Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction- A Randomized Control Trial.
Phase: NA
Conditions: Tooth, Impacted
Sponsor: Jamia Millia Islamia

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
 
Title page 
 
TITLE: Oral health related quality of life and clinical outcomes in patients undergoing 
canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604 
 
PROPOSED DEPARTMENT & PLACE OF STUDY:  
Dept. of Orthodontics, Faculty of Dentistry, Jamia Millia Islamia, New Delhi 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
RESEARCH PROPOSAL 
 
TITLE: Oral health related quality of life and clinical outcomes in patients undergoing 
canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604 
 
OBJECTIVES:  
1. To assess oral health related quality of life in patients undergoing canine disimpaction 
through Questionnaire. 
2. To assess periodontal outcomes between the open and closed surgical techniques. 
3. To assess whether there are differences in patient reported outcomes between the 
open and closed surgical techniques. 
 
1. BACKGROUND KNOWLEDGE: 
Impacted canines are permanent teeth that could not erupt at its normal chronological age 
due to its displacement to abnormal position in the roof of mouth (palate), or due to 
obstruction in its path of eruption or inherent deficient eruption potential. This is a 
frequently occurring anomaly, present in 2% to 3% of the population.1 Management of 
this problem is both time consuming and expensive and involves surgical exposure 
(uncovering of palatal mucosa) along with fixed orthodontic appliance to bring the canine 
into its normal position and alignment within the dental arch. 
 
Two techniques for surgical exposure of palatally impacted canines are routinely 
followed:  
a) Open surgical technique, involves surgical uncovering of the palatal mucosa 
overlying impacted canine by creation of a window in the palatal mucosa, and a dressing 
is placed to cover the exposed area. Then approximately 10 days later, this pack is 
removed and the canine is allowed to erupt naturally. Once the tooth has erupted 
sufficiently for an orthodontic attachment to be bonded to its surface, orthodontic 
treatment is commenced to bring this tooth into its correct position in dental arch the 
through the palatal mucosa.  
b) Closed surgical technique involves surgical uncovering of palatal mucosa above the 
impacted canine by full thickness flap and bonding an attachment over the exposed 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
surface of canine, repositioning/suturing of palatal mucosa and then with the help of 
bonded attachment, orthodontically moving this canine into its correct position from 
beneath the palatal mucosa.2  
 
2. REASON OF THE STUDY:  
Through this prospective study, clinical outcomes and patient experiences for both these 
techniques will be evaluated.  
Permanent maxillary canines usually erupt in the mouth at the age of 11 to 12 years. They 
play a vital role in facial appearance, dental aesthetics, arch development and functional 
occlusion i.e the canine guided occlusion. The process of eruption of the permanent 
canines leading to their final positioning in the oral cavity is complex and the longest of 
all the permanent teeth which may leads to impaction or eruption of these canines into 
abnormal position. Impacted canines are usually asymptomatic, however, impaction may 
cause severe complications such as development of malocclusion and some pathological 
conditions e.g. dentigerous cysts. The most common irreversible and adverse effect of 
maxillary canine impaction is root resorptions. Their impaction can also cause damage to 
the roots of neighboring teeth by causing resorption of their roots and the damage may be 
so severe that these teeth are subsequently lost. The tissue that is the dental follicle 
around these impacted canine teeth may undergo cystic changes. Impaction of these teeth 
can also lead to aesthetic problems due to a gap created in the dental arch in the area at 
their position. Hence negative physical and psychological impact can occur to the patient. 
Therefore it is important to disimpact these teeth and bring them into their correct 
occlusal position within the dental arch. 3,4 
 There are only a few clinical trials, where open and closed surgical exposure of canine 
are compared on various outcomes. Most of these studies are retrospective and due to the 
biases involved, they provide very little conclusive evidence.5,6,7 
A study by Wisth5 compared closed and open techniques. 34 participants received an 
open exposure and 22 patients received a closed exposure. It was found that the mean 
duration of treatment was 4 months longer in the closed group and it was reported that 
this was likely due to lack of direct vision of the canine from when it was exposed to 
when it was brought into the line of the arch. The closed group appeared to have less 
periodontal damage in terms of loss or attachment and bone levels. The study however 
was retrospective, pretreatment equivalence was not established (in terms of participant’s 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
age or severity of canine displacement) and therefore the risk of selection and detection 
bias was high. 
Woloshyn6 study, all palatally displaced canines received a closed exposure. This study 
found that the roots of the impacted canine and adjacent lateral incisor were slightly 
shorter than those of the contralateral canine and that the treated canine could be visually 
differentiated from the control canine in 70% to 80% of cases. They came to a conclusion 
that the overall consequences to the impacted canine with open technique seem better 
than with a closed technique. This is in contrast to findings of Becker8 reported excellent 
periodontal health following alignment of canines using a closed technique. Importantly, 
all these mentioned studies, are retrospective and findings therefore score low in terms of 
evidence.  
Sampaziotis et al9 in their systematic review concluded that there is a need for 
randomized clinical trials (RCTs) to compare the two treatment alternatives and more 
RCTs should be performed in the future for stronger evidence and clarification of some 
controversial issues. 
According to a recent Cochrane review10, the studies conducted had high risk of bias and 
thus were very low in evidence to support any decision. Thus, particular conclusion as to 
which technique of surgical exposure is superior in terms of periodontal health, aesthetic 
and patient comfort cannot be attained.  
The present study has been designed keeping the lacunae in previous literature in mind. 
Currently, there is little evidence to support one surgical technique over the other in terms 
of dental health, aesthetics and patient factors. Therefore, a high quality prospective 
clinical trial with participants randomly allocated into the two treatment groups need to be 
conducted. Otherwise, methods of exposing canines will be left to the personal choice of 
the surgeon and orthodontist.  
 
3. METHODOLOGY: 
Study design: A unicentric, randomized controlled clinical trial involving 2 parallel 
groups (Group 1 for open surgical technique and group 2 for closed surgical technique) 
where contralateral side fully erupted and normally positioned canine will be considered 
as control. The study will be conducted in Department of Orthodontics, Faculty of 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Dentistry, Jamia Millia Islamia post ethical committee approval by institutional ethics 
committee.  
Written informed consent will be taken from all the patients enrolling in the study.  
Estimation   of  Sample  Size: Assuming  the   mean   difference  of   the primary   
outcome  (measure  of clinical attachment)  as  0.5 mm with standard   deviation   as  0.61 
mm  between   the  open and closed  exposure  group  ( Reference  : Periodontal health of 
palatally displaced canines treated with open or closed surgical technique: A multicenter, 
randomized controlled trial. American Journal of Orthodontics and Dentofacial 
Orthopedics August 2013 ; 176-84; Vol 144 ;Issue 2)  with alpha (level of  significance)  
<0.05  , Power=80% ,  2 sided hypothesis,   the total   minimum sample  size  40   will  be  
required   to  detect  the minimum significant   difference of  the primary outcome.  The 
total sample size can be randomized in equal no. as 20  in each group  (open and closed 
group). Twenty patients who meet the below mentioned criteria will be randomly 
allocated in each group. Participants for the trial will be identified from treatment waiting 
lists and new patient clinics.  
 
Inclusion criteria: 
 Patients with unilateral and favorably placed palatally ectopic maxillary canines who 
require surgical exposure for orthodontic alignment of impacted canine on contralateral   
side of same arch. The other side will be taken as control canine. 
 Age 13-25 years  
 Minimal orthodontic malocclusion other than the ectopic canine 
 Good oral hygiene and motivation to wear fixed appliances for at least 2 years 
 
Exclusion criteria: 
 Patients with contralateral ectopic maxillary canines. 
 Periodontal disease (bleeding on probing, pocket probing depths 3 mm and decreased 
bone levels as diagnosed from baseline panoramic imaging) 
 Cases in which the canine is to be brought into the position of the lateral incisor or 
premolar. 
 Compromising medical conditions (patients requiring antibiotic prophylaxis to prevent 
infective endocarditis) 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
 
Radiographic diagnosis of palatal impaction: 
The horizontal parallax method will be used since it is more reliable than vertical 
parallax. A periapical film would be placed in mouth on the palatal aspect of the area 
where the tooth is normally situated. The X-ray tube is directed at right angles to a 
tangent to the line of the arch at this point and at appropriate angle to the horizontal 
plane as for any periapical view. A second film is placed in the mouth in the identical 
position but, on this occasion, the x-ray tube would be shifted distally but held at the 
same angle to the horizontal plane and directed mesially. To do this the tube should 
describe 30-450 of an arc of a circle, whose center is somewhere in the middle of the 
palate. The IOPA Xray which would be taken from distal will be marked “D” for 
identification. 
 
Randomization: 
Randomization procedures and reporting include the following steps. 
1. Generation of the random allocation sequence, including details of any restrictions: 
Minimization, a form of restricted randomization, is considered to be a dynamic method, 
since the randomization list is not produced before the trial starts, but during participant 
recruitment. Additionally, minimization, in contrast to the previous methods, is 
considered to be an adaptive randomization technique, since future participant allocation 
depends on previous assignments. Once consent had been obtained, each participant will 
be randomly allocated to group 1 or group 2.  
 
2. Allocation concealment and implementation of the random allocation sequence: 
Blinding of the investigator is not possible so to reduce bias one of the staff assistant 
who was neutral towards treatment will be allocated the job of assigning patient in the 
two treatment groups. The first 5 patients will be allocated according to simple 
randomization and from 6th patient onwards minimization will be followed.  
The prognostic factors or predictors will be used like severity of impaction, age, oral 
hygiene, presence of crowding, and rotation of canine. The severity of the canine 
impaction will be assessed by a single blinded assessor, from the pretreatment panoramic 
imaging film, using the criteria described by Ericson and Kurol. 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Treatment Protocol: 
The orthodontic treatment will be done by single orthodontist who will follow a strict 
protocol as follows: 
 
1. Initial orthodontic alignment will be aimed at creating space in the maxillary arch 
with fixed appliance therapy (0.022 slot) .The surgical procedure will be done after 
reaching a full size wire of 19X25 S.S with open coil spring to maintain space for the 
permanent canine. Anchorage preparation will also be done with the help of TPA.  
 
2. Surgical exposure and orthodontic traction. 
The tooth will be sufficiently exposed to bond an orthodontic attachment (button). NiTi 
closed coil (0.018”S.S. wire) spring will be used to vertically extrude highly placed 
palatal canine impactions till the time it erupts sufficiently so as not to resorb the roots. 
After that traction force will be applied followed by ligature with e chain which will be 
hooked to the helix to get it in the line of arch once it has extruded sufficiently so as not 
to interfere with the roots. The duration of this phase (duration of traction) will be 
calculated as the time between the application of the traction device and the alignment of 
the impacted canine. 
 
3. Finishing: Orthodontic finishing of case to align the canine in the maxillary arch. 
All surgical procedures will be carried out under local anesthesia by a single specialist 
(Oral and maxillofacial surgeon) having experience of practicing both surgical 
techniques: open and closed. 
 
Open Surgical Exposure of Impacted canine:  
 Surgically uncover the canine tooth and bone removal exposing the largest diameter of 
the ectopic canine crown. The edges need to be substantially trimmed back and dental 
follicle removed to prevent regrowth of the very thick palatal mucosa. For a deeply 
buried and palatally displaced tooth, the exposure will additionally need to be 
maintained using surgical pack. 
 Coe-pack surgical dressing (GC America Inc, Alsip, IL) will be left in place. 
 The patient will be reviewed 10 days later, the surgical pack will be removed and the 
bracket will be bonded and loading will be done by traction forces. Once the tooth has 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
erupted sufficiently for an orthodontic attachment to be positioned at its correct location 
to bring the tooth into line. 
 
Closed Surgical Exposure of Impacted canine:  
 Surgically, the palatal mucosal full thickness flap overlying the impacted canine will be 
raised and surgical bone removal exposing the largest diameter of the ectopic canine 
crown. 
 An orthodontic attachment (button) with ligature wire and bracket with closed coil 
spring will be bonded to the palatal or buccal surface of the ectopic canine crown 
(whichever was the most accessible).  
 
Outcome Assessment: 
The following outcomes will be measured during and post orthodontic treatment: 
 
Primary Outcome Measures: 
1. Oral health based Quality of life of patients undergoing canine disimpaction will be 
accessed by questionnaire. (Annexure 1) 
2. Measurement of width of attached gingiva. Measures which assess the periodontal 
outcome like crown length, gingival recession, bone will be assessed. (Annexure 2). 
 
Secondary Outcome Measures: 
3. Pain score on the visual analogue scale [Time Frame: 10 days post-surgery], many 
patient reported outcomes like the number of times the bond failure take place, surgical 
time, pain associated with surgery will be assessed. (Annexure 3) 
 
4. EXPERIMENTAL SCHEDULE & OUTCOME FOR 3 YEARS: 
Time in Months 
1-2m 
2-12m 
12-30m 
30-36m 
Training 
of 
Research Associate 
and enrollment of 
patients 
 
 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Implementation of 
project 
and 
treatment phase 
 
 
 
 
Data Analysis and 
compilation 
of 
results 
 
 
 
 
 
 
5. SHADOW PRICING OF PROPOSED STUDY & MODALITIES: This is a 
routine fixed orthodontic procedure in Dept. of Orthodontics, Faculty of Dentistry, 
Jamia Millia Islamia and materials related to this project will be provided by the 
institute. 
 
6. SCIENTIFIC IMPACT OF PROPOSED STUDY: According to present literature, 
there is no evidence to support either the open or the closed technique for exposing 
palatally ectopic canines to be clinically superior in terms of dental health, aesthetics, 
economics and patient factors. There is a high need for randomized clinical trials on 
this subject, the current literature provides very weak evidence. Current evidence gaps 
need to be filled. Our study aims at providing evidence as to which technique should be 
used to expose palatally impacted canines, open or closed. It will take into 
consideration the primary outcomes like periodontal health of the disimpacted teeth as 
well as the secondary outcomes that is the patient reported outcomes including patient 
comfort and aesthetics. This study might provide some good evidence which could help 
the surgeon and orthodontist to decide the suitable approach for a particular case. 
 
7. INSTITUTIONAL ETHICAL COMMITTEE CLEARANCE: 
The project has received approval from Institutional ethical committee (IEC), Jamia 
Millia Islamia, New Delhi. 
 
8. MY SPECIFIC FUNCTION & ROLE IN THE PROPOSED STUDY: 
After allocation of patients in both the groups, being an investigator, my role shall be 
clinical intervention from bonding the brackets to orthodontic dis-impaction of 
impacted canines to its normal position. Being a clinical research project, it will be 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
help in practicing both clinical, and research analysis. It will be a team effort i hope to 
contribute to the practice of evidence based dentistry through this project. By 
performing it to best of my abilities and minimizing bias. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
REFERENCES: 
1. Grover PS, Lorton L. The incidence of unerupted permanent teeth and related clinical 
cases. Oral Surg Oral Med Oral Pathol. 1985;59(4):420-5. 
2. Clark J, Davis M, Harden R. National responses. Clinical audit: scenarios for 
evaluation and study. Dundee: University of Dundee, Centre for Medical Education, 
1994: 76. 
3. Shafer WG, Hine MK, Levy BM. A textbook of oral pathology. 4th Edition. 
Philadelphia, PA: Saunders, 1983: 66–9.  
4. Nagpal A, Sharma G, Sarkar A, Pai KM. Eruption disturbances: An aetiological-
cummanagement perspective. Dentomaxillofac Radiol.2000; 34(1):59-63. 
5. Wisth PJ, Norderval K, Boe OE. Periodontal status of orthodontically treated 
impacted maxillary canines. Angle Orthodontist 1976; 46(1):69–76. 
6. Woloshyn H, Artun J, Kennedy DB, Joondeph DR. Pulpal and periodontal reactions 
to orthodontic alignment of palatally impacted canines. Angle Orthodontist 
1994;64(4): 257–64.  
7. Parkin N, Milner R, Deery C et al, Periodontal health of palatally displaced canines 
treated with open or closed surgical technique: A multicenter randomized controlled 
trial AmJoDo 2013;144:176-84. 
8. Becker A, Kohavi D, Zilberman Y. Periodontal status following the alignment of 
palatally impacted canine teeth. American Journal of Orthodontics 1983; 84:332–6.  
9. Sampaziotis D, Tsolakis I , Bitsanis E, Tsolakis A. Open versus closed surgical 
exposure of palatally impacted maxillary canines: comparison of the different 
treatment outcomes—a systematic review. Eu J Orthod 2018;40:11-22. 
10. Parkin, N., Benson, P. E., Thind, B. and Shah, A. (2008) Open versus closed surgical 
exposure of canine teeth that are displaced in the roof of the mouth. The Cochrane 
Database of Systematic Reviews, 8, CD006966  
 
 
 
 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
OUTCOME: Annexure 1;1 
Oral Health Impact Profile Questionnaire (OHIP-14) 
(Pre-treatment) 
 
S.no 
Questions 
Score (Tick any one) 
 
 
Very 
Often 
Fairly 
Often 
Occasio
nally 
Hardly 
ever  
 
Never 
Don't 
know 
1. 
Have you had trouble pronouncing any words because of 
problems with your teeth or mouth? 
O O O O O O 
2. 
Have you felt that your sense of taste has worsened because of 
problems with your teeth or mouth? 
O O O O O O 
3. 
Have you had painful aching in your mouth? 
O O O O O O 
4. 
Have you found it uncomfortable to eat any foods because of 
problems with your teeth or mouth?  
O O O O O O 
5. 
Have you been self-conscious because of your teeth or mouth? 
 
O O O O O O 
6. 
Have you felt tense because of problems with your teeth or 
mouth? 
O O O O O O 
7. 
Has been your diet been unsatisfactory because of problems with 
your teeth of mouth? 
O O O O O O 
8. 
Have you had to interrupt meals because of problems with your 
teeth or mouth? 
O O O O O O 
9. 
Have you found it difficult to relax because of problems with your 
teeth or mouth? 
O O O O O O 
10. 
Have you been a bit embarrassed because of problems with your 
teeth or mouth? 
O O O O O O 
11. 
Have you been a bit irritable with other people because of 
problems with your teeth or mouth? 
O O O O O O 
12. 
Have you had difficulty doing your usual jobs because of 
problems with your teeth or mouth? 
O O O O O O 
13. 
Have you felt that life in general was less satisfying because of 
problems with your teeth or mouth? 
O O O O O O 
14. 
Have you been totally unable to function because of problems 
with your teeth or mouth? 
O O O O O O 
 
  
 
 
 
 
 
 
 
 
 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Annexure 1;2 
Oral Health Impact Profile Questionnaire (OHIP-14) 
(Post-treatment) 
 
S.no 
Questions 
Score (Tick any one) 
 
 
Very 
Often 
Fairly 
Often 
Occasio
nally 
Hardly 
ever  
 
Never 
Don't 
know 
1. 
Have you had trouble pronouncing any words because of 
problems with your teeth or mouth? 
O O O O O O 
2. 
Have you felt that your sense of taste has worsened because of 
problems with your teeth or mouth? 
O O O O O O 
3. 
Have you had painful aching in your mouth? 
O O O O O O 
4. 
Have you found it uncomfortable to eat any foods because of 
problems with your teeth or mouth?  
O O O O O O 
5. 
Have you been self-conscious because of your teeth or mouth? 
 
O O O O O O 
6. 
Have you felt tense because of problems with your teeth or 
mouth? 
O O O O O O 
7. 
Has been your diet been unsatisfactory because of problems with 
your teeth of mouth? 
O O O O O O 
8. 
Have you had to interrupt meals because of problems with your 
teeth or mouth? 
O O O O O O 
9. 
Have you found it difficult to relax because of problems with your 
teeth or mouth? 
O O O O O O 
10. 
Have you been a bit embarrassed because of problems with your 
teeth or mouth? 
O O O O O O 
11. 
Have you been a bit irritable with other people because of 
problems with your teeth or mouth? 
O O O O O O 
12. 
Have you had difficulty doing your usual jobs because of 
problems with your teeth or mouth? 
O O O O O O 
13. 
Have you felt that life in general was less satisfying because of 
problems with your teeth or mouth? 
O O O O O O 
14. 
Have you been totally unable to function because of problems 
with your teeth or mouth? 
O O O O O O 
 
  
 
 
 
 
 
 
 
 
 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Annexure 1;3 
 
Oral Health related Quality of life Questionnaire  
(24hrs after surgery) 
How much trouble you have with your teeth or mouth? 
S.no 
Questions 
Score (Tick any one) 
 
 
No 
trouble 
A little 
trouble 
Some 
trouble 
Quite a lot 
trouble 
Lots of 
trouble 
1. 
Eating/chewing foods you want  
O 
O 
O 
O 
O 
2. 
Opening your mouth wide 
O 
O 
O 
O 
O 
3. 
Sleeping 
O 
O 
O 
O 
O 
4. 
Talking to people so that they can understand you 
O 
O 
O 
O 
O 
5. 
Going about your everyday routine 
O 
O 
O 
O 
O 
6. 
Taking part in your social life 
O 
O 
O 
O 
O 
7. 
Taking part in sports 
O 
O 
O 
O 
O 
8. 
Swelling of your cheeks 
O 
O 
O 
O 
O 
9. 
Bruising 
O 
O 
O 
O 
O 
10. 
Bleeding 
O 
O 
O 
O 
O 
11. 
Nausea 
O 
O 
O 
O 
O 
12. 
Bad taste / bad breath 
O 
O 
O 
O 
O 
13. 
Food collecting in the hole after the teeth were pulled 
O 
O 
O 
O 
O 
14. 
Rate the worst pain you have felt in your teeth, mouth and face 
during past 24 hrs. 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Annexure 1;4 
Oral Health related Quality of life Questionnaire 
(Ten days after surgery) 
How much trouble you have with your teeth or mouth? 
S.no 
Questions 
Score (Tick any one) 
 
 
No 
trouble 
A little 
trouble 
Some 
trouble 
Quite a lot 
trouble 
Lots of 
trouble 
1. 
Eating/chewing foods you want  
O 
O 
O 
O 
O 
2. 
Opening your mouth wide 
O 
O 
O 
O 
O 
3. 
Sleeping 
O 
O 
O 
O 
O 
4. 
Talking to people so that they can understand you 
O 
O 
O 
O 
O 
5. 
Going about your everyday routine 
O 
O 
O 
O 
O 
6. 
Taking part in your social life 
O 
O 
O 
O 
O 
7. 
Taking part in sports 
O 
O 
O 
O 
O 
8. 
Swelling of your cheeks 
O 
O 
O 
O 
O 
9. 
Bruising 
O 
O 
O 
O 
O 
10. 
Bleeding 
O 
O 
O 
O 
O 
11. 
Nausea 
O 
O 
O 
O 
O 
12. 
Bad taste / bad breath 
O 
O 
O 
O 
O 
13. 
Food collecting in the hole after the teeth were pulled 
O 
O 
O 
O 
O 
14. 
Rate the worst pain you have felt in your teeth, mouth and face 
during past 24 hrs. 
1 
2 
3 
4 
5 
 
15.  
Are you still taking any pain killers? (yes/no) 
 
16.  
If yes, How many days you took and frequency  
 
 
 
 
 
 
 
 
 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
 
2. CLINICAL OUTCOMES (Annexure 2) 
(To be measured after 1 month post debond): 
 
Group: open/closed 
 
1. Pocket Depth 
 
2. KT width  
 
3.  
a. Gingival recession, if any, measured on the buccal midpoint of the 
canine crown. 
b. Gingival recession, if any, measured on the buccal midpoint of the 
L.I.  crown. 
 
4. Clinical crown length-incisal edge to gingival margin on midfacial 
surface parallel to the long axis. 
 
5. Clinical crown length-incisal edge to gingival margin on midfacial 
surface parallel to the long axis of the contralateral tooth  
 
6. Time period it took to align 
DOE 
DOA 
7. How many times did bracket debond 
 
8. How many times flap was raised. 
 
9. Probing bone level-subtracting the distance CEJ to gingival margin 
from the distance gingival margin to bone. 
 
10. Bleeding on probing 
 
11. Loe and silness score 
 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Operator’s measure of surgical ease (Annexure 3) 
 
Group (open/closed): 
 
S.NO.  QUESTION  
 
1.  
Actual surgical time- from incision to last suture 
 
2.  
Difficulties felt by Operator 
 
3.  
Number of times flap was raised 
 
4. 
No of times button debonded 
 
5.  
Duration of traction phase till alignment of canine  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Maxillary Canine Aesthetic Index scoring sheet  
 
( Annexure 4) 
Patient name: ………………………….                            
Date of recording: …………………………. 
Working side: ……………………………….. 
 
Parameters investigating the previously impacted canine 
 
Absent  
Incomplete  
Complete 
Mesial papilla  
 
 
 
Distal papilla 
 
 
 
Marginal gingiva 
 
 
 
Recession  
 
 
 
Marginal gingival thickness 
 
 
 
Mesiodistal canine angulation  
 
 
 
 
Parameters investigating comparison between both canines 
 
Major 
discrepancy  
Minor 
discrepancy  
No 
discrepancy 
Curvature of marginal gingiva  
 
 
 
Soft tissue color and texture  
 
 
 
Root convexity  
 
 
 
Tooth morphology  
 
 
 
Vertical tooth position  
 
 
 
 
Parameters investigating relation previously impacted canine and neighboring teeth 
Bucco-lingual angulation crown 
acc. neighboring teeth  
 
 
 
Total score 0–3 points = excellent  
4–8 points = good 
9–13 points = moderate 
14 or more points = poor aesthetics 
Total score = 
 
 
 
 
 
 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Baseline Data 
 
 Patient’s name: 
Age/sex:  
UID no: 
Case no: 
Contact number: 
Address: 
Side of Impaction 
Severity of Impaction (Ericson and Kurol) 
Angle: 
Vertical height: 
Sector: 
Oral Hygiene: 
Date of start of fixed treatment: 
Date of surgical exposure: 
Date of alignment of canine: 
Date of debonding: 
 
 
 
 
 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Institutional Ethics Committee (IEC) 
Jamia Millia Islamia 
Annexure III (Subject Information Sheet and Consent Form for Patients) 
Title of the project:  
Oral health related quality of life, clinical outcomes in patients undergoing canine 
disimpaction- A Randomized Control Trial. 
Site of the investigation:  
Department of Orthodontics, Oral surgery and Periodontology, Faculty of Dentistry, Jamia 
Millia Islamia, New Delhi, 110025 
Name, address and contact number of the Principal Investigators: 
Dr. Panchali Batra 
Professor, 
Department of Orthodontics. 
Contact 9999908022 
 
 
Aims and methods of the research 
The permanent canine or corner tooth in the upper arch usually erupts by the age of 11-12 
years. Sometimes, this tooth may not erupt in the oral cavity and may remain impacted inside 
the bone. This tooth has the longest root, supports the corners of the mouth and helps to 
protect other teeth during function hence it is very important to save this tooth and do every 
effort to save or align/disimpact this tooth. Leaving this tooth in the bone might sometimes 
lead to unfavourable consequences like root resorption of the adjacent teeth or development 
of cysts. To align this tooth in the arch, the patient needs fixed braces treatment so that 
traction force can be applied to the tooth. Since this tooth impacted, is covered by soft tissue 
or bone, and is not visible in the oral cavity, the tooth has to be uncovered by a minor surgical 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
procedure so that the bracket can be placed on that tooth and then traction force could be 
applied. There are 2 commonly used methods of exposing the tooth surgically-open surgical 
method in which the tooth remains open and visible in the oral cavity throughout the 
alignment period, and the closed method in which the flap is restored back and tooth is not 
visible. Since there is lack of high quality evidence as to which surgical approach is better, it 
is left to the discretion of the surgeon to select the surgical method of exposure. This study 
aims to evaluate the difference in the results of the two methods by assessing the clinical and 
patient related outcomes. The patients will be randomly divided into the two groups. Both the 
surgical procedures are routine procedures applied for disimpaction. An oral health related 
quality of life related to experiences of patient undergoing disimpaction will be collected by a 
written questionnaire format. 
1. 
Expected duration of the subject participation. 
Three years 
2. 
The benefits to be expected from the research to the subject or to others. 
Our research project will help us improve our understanding as to which method of surgical 
treatment is better and will be evidence based. This will help the clinician to give clear 
indications for each surgical method and may benefit patients as repeated trauma due to 
surgeries could be avoided. Also patient with impacted canine will benefit from its alignment 
in arch for better function and aesthetics.  
3. 
Alternative treatment/procedure options. 
 These are the only two surgical methods followed, there are no alternatives.  
4. 
Right to prevent use of biological samples (DNA, cell line etc.) at any time during 
the research. 
Not applicable as no biological samples as DNA, Cell line are collected in this study. 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
5. 
Any risk to the subject associated with the study. 
There are no major health risks of taking part in this study as it’s a conventional procedure of 
disimpaction. Through this research we intend to only observe the features of both the 
techniques and these are being practiced as standard procedures. We do not anticipate any 
major threat to life and health because of this treatment.  
6. Maintenance of confidentiality of records. 
All the personal information of the patient that is collected during the course of the research 
will be kept strictly confidential. The data regarding results of the study will be used for 
publication without disclosing identity of the subjects.  
7. 
Provision of free treatment for research related injury. 
There is no anticipation of any additional risks or injury related to research project. In the 
event of a bodily injury or illness directly resulting from the study, the institute will give 
reasonable and necessary treatment. ‘Jamia Millia Islamia’ is not responsible for medical 
expenses due to pre-existing medical conditions, any underlying diseases, any ongoing 
treatment process and negligence or willful misconduct of the patient or investigator.  
8. 
Compensation of subjects for disability or death resulting from such injury. 
We do not anticipate any disability or death from this research procedure.  
9. 
Freedom of individual to participate or to withdraw from research at any time 
without penalty or loss of benefits to which the subject would otherwise be entitled. 
You are free to withdraw at any time and without giving a reason. A decision to withdraw at 
any time, or a decision not to take part, will not affect the standard of care you receive. 
10. 
Amount of clinical sample in quantity, to be taken should be mentioned. 
No clinical sample (eg. blood, urine, sputum) is collected from patient for this study, only 
clinical observations are made in this study.  
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
11. 
Source of funding for the Investigation. 
Nothing additional will be charged from patient for research project. The patients will be 
charged by institute as per its existing subsidised charges for dental treatment.  
 
12. 
In case of drug trials: 
a) 
The chemical name of drug, date of its manufacturing and batch number must 
be mentioned - Not applicable 
b) 
Initial bio equivalent study of the drug/references should be provided - Not 
applicable.  
 
13. 
Foreseeable extent for information on possible current and future usage of the 
biological material and of the data to be generated from the research and if the material 
is likely to be used for secondary purposes or would be shared with others, clear 
mention of the same.  
The data generated from this research may be used for research publication purposes but 
identity of individual and sensitive personal information will be kept confidential. Data will 
not be put to any secondary purpose. 
 
14. 
Risk of discovery of biologically sensitive information. 
Biological sensitive information will be kept confidential.  
 
15. 
Publication, if any, including photographs and pedigree charts. 
At the end of the study all the information will be put together and the results will be 
presented and published in a peer reviewed journal and confidentiality of the patient personal 
information will be maintained. 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Responsibility of Investigators. 
Investigators take the responsibility that your treatment will not be changed or altered in 
any way because you are in this study. Also all your records shall be kept confidential and 
will not be revealed to any outsider. 
 
Consent 
1. I agree voluntarily to take part in this study. 
2. I have been explained the purpose and other details of the study. I have been given a 
full explanation of the procedures involved. 
3. I have been given an opportunity to ask questions and all my questions have been 
answered to my satisfaction. 
4. I am free to withdraw from the study at any time without any reason and without my 
medical care or legal right being affected. 
5. I understand that the information in my medical records is essential to evaluate the 
results of the study. I agree to release this information on the understanding that will 
be treated confidentially. 
6. I agree that I will not be referred to by name in any reports/documents/any other 
means concerning this study. 
7. I have been explained the risks and benefits for the patients and society associated 
with the study. 
8. I agree that if I am harmed as result of taking part in the study, treatment will be 
provided free of cost by the PI/Institution/University. 
9. I agree/ do not agree that the data collected during this study may be stored for future 
use.  
 
 
I willingly agree to take part in the above study. 
 
 
 
 
Signature of the participant/guardian                              Date: 
Name: 
Age: 
 
Address: 
 
 
 
Signature of the doctor/Principal Investigator:             Date: 
 
 
 
 
Signature of the witness:                                                 Date: 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Signature page for patients between ages 13 - 17 years of age: 
1. I agree that my child is voluntarily taking part in this study. 
2. I have been explained the purpose and other details of the study. I have been given a 
full explanation of the procedures involved. 
3. I have been given an opportunity to ask questions and all my questions have been 
answered to my satisfaction. 
4. I know that my child is free to withdraw from the study at any time without any 
reason and without my medical care or legal right being affected. 
5. I understand that the information in my child’s medical records is essential to evaluate 
the results of the study. I agree to release this information on the understanding that 
will be treated confidentially. 
6. I agree that my child will not be referred to by name in any reports/documents/any 
other means concerning this study. 
7. I have been explained the risks and benefits for the patients and society associated 
with the study. 
8. I agree that if my child is harmed as result of taking part in the study, treatment will 
be provided free of cost by the PI/Institution/University. 
9. I agree/ do not agree that the data collected during this study may be stored for future 
use 
I willingly agree that my child will take part in the above study. 
 
 
 
Signature of the parent/guardian                              Date: 
 
 
 
Assent of child: ------------------------ (name of child/minor) has agreed to participate in above 
study 
 
 
 
Signature of the child  
 
Date: 
 
Name: 
Age: 
 
Address: 
 
 
 
Signature of the doctor/Principal Investigator:             Date: 
 
 
 
 
Signature of the witness:                                                 Date:   
  

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
Institutional Ethics Committee (IEC) 
JamiaMilliaIslamia 
Annexure III (Subject Information Sheet and Consent Form for Patients in Hindi) 
परियोजना का शीर्षक: 
कैनाइन विच्छेदन के दौर से गुजर रहे रोगगयों में मौखिक स्िास््य से संबंगित जीिन की 
गुणित्ता, नैदाननक पररणाम- एक यादृच्च्छक ननयंत्रण परीक्षण। 
जांच के साइट: 
दंत गिककत्सा के ओर्थोडोंटिक विभाग, संकाय, जाममया मममिया इस्िाममया, नई टदल्िी, 110025 
नाम, पता औि प्रधान जांचकताष के सांपकष नांबि: 
डॉ पांिािी बत्रा 
प्रोफेसर, 
ओर्थोडोंटिक  विभाग। 
संपकक 9999908022 
लक्ष्य औि अनुसांधान के तिीके 
मुँह की छत में फसे कैनाइन दांत को बेनकाब करने के मिए एक िुिी या बंद शल्य गिककत्सा 
पद्िनत में कोई मतभेद नही है । परीक्षण के मिए प्रनतभागगयों को उपिार प्रतीक्षा सूिी और नए 
मरीज क्िीननक से पहिाना जाएगा। िुिी या बंद शल्य गिककत्सा पद्िनत: िे बेतरतीब ढंग से दो 
समूहों में आिंटित ककया जाएगा। मरीज के मुंह के अन्य िृत्त का ितुर्थक भाग ननयंत्रण के रूप में 
कायक करेगा। 
एक तकनीक में फ्िैप उठाया जाएगा अिैिमेंि  बॉिा जाएगा और कफर फ्िैप कफर से िापस सीिन 
ककया जाएगा।अन्य तकनीक में फ्िैप उठाया जाएगा और एक खिड़की बनाया जाए गी और अिैिमेंि 
बाद में  बॉिा जाएगा । इिाज पूरा हो गया है जब तक रोगी की समीक्षा की जाएगी। रोगी को जीिन 
की मौखिक स्िास््य गुणित्ता से संबंगित एक प्रश्नाििी भरने के मिए कहा जाएगा.  
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
 
1.विर्य भागीदािी की अनुमाननत अिधध। 
3 साि 
2. अनुसांधान के लाभ 
हमारी शोि पररयोजना से हमें यह समझने में मदद ममिेगी कक सच्जककि उपिार का कौन 
सा तरीका बेहतर है और साक्ष्य आिाररत होगा। इससे गिककत्सक को प्रत्येक शल्य गिककत्सा 
पद्िनत के मिए स्पष्ि संकेत देने में मदद ममिेगी और रोगगयों को िाभ हो सकता है 
क्योंकक सजकरी के कारण बार-बार होने िािे आघात से बिा जा सकता है। इसके अिािा 
प्रभावित कैनाइन िािे रोगी को बेहतर कायक और सौंदयकशास्त्र के मिए आिक में इसके संरेिण 
से िाभ होगा। 
3. िैकल्पपक उपचाि / प्रक्रिया विकपप। 
कोई नहीं।  केिि ये दो शल्य गिककत्सा पद्िनतयों का पािन ककआ जाता है । 
1. शोध के दौिान क्रकसी भी समय जैविक नमूने (डीएनए, सेल लाइन आदद) के उपयोग को िोकने का 
अधधकाि: 
िागू नहीं है क्योंकक इस अध्ययन में डीएनए, सेि िाइन के रूप में कोई जैविक नमूने एकत्र 
नहीं ककए गए हैं। 
5. अध्ययन से जुडे विर्य के ललए क्रकसी भी प्रकाि का जोखिम: 
 
इस अध्ययन में भाग िेने का कोई बड़ा स्िास््य जोखिम नहीं है क्योंकक यह एक पारंपररक 
प्रकिया है। इस शोि के माध्यम से हम केिि दोनों तकनीकों की विशेषताओं का ननरीक्षण 
करना िाहते हैं और इन्हें मानक प्रकियाओं के रूप में अभ्यास ककया जा रहा है। हम इस 
उपिार के कारण जीिन और स्िास््य के मिए ककसी बड़े ितरे की आशंका नहीं रिते हैं। 
6.रिकॉडष की गोपनीयता: 
रोगी की सभी व्यच्क्तगत जानकारी जो अनुसंिान के दौरान एकत्र की जाती है उसे कड़ाई से 
गोपनीय रिा जाएगा। अध्ययन के पररणामों से संबंगित डेिा का उपयोग विषयों की पहिान 
का िुिासा ककए बबना प्रकाशन के मिए ककया जाएगा। 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
 
7.अनुसांधान से सांबांधधत चोट लगने पि मुफ्त इलाज का प्रािधान: 
अनुसंिान पररयोजना से संबंगित ककसी भी अनतररक्त जोखिम या िोि की कोई आशंका नहीं 
है। अध्ययन के पररणामस्िरूप सीिे शारीररक िोि या बीमारी की च्स्र्थनत में, संस्र्थान उगित 
और आिश्यक उपिार देगा। 'जाममया मममिया इस्िाममया' पहिे से मौजूद गिककत्सा 
च्स्र्थनतयों, ककसी अंतननकटहत बीमारी, ककसी भी िि रही उपिार प्रकिया और िापरिाही या 
रोगी या अन्िेषक की जानबूझकर कदािार के कारण गिककत्सा ििों के मिए च्जम्मेदार नहीं 
है। 
8. इस तिह की चोट से उत्पन्न विकलांगता या मौत के ललए विर्यों का मुआिजा। 
हम इस शोि से ककसी विकिांगता या मृत्यु का अनुमान नहीं िगाते हैं। 
9. क्रकसी भी समय अनुसांधान में भाग नहीां लेने की व्यल्तत की स्ितांत्रता बबना क्रकसी जुमाषना 
या लाभ की हानन के, ल्जसके विर्य अन्यथा हकदाि होंगे । 
यह अध्ययन स्िैच्च्छक है; यह तय करना आप पर ननभकर है। अगर आप भाग िेने के मिए 
मना कर दें तो इस से आपके देिभाि या उपिार पर असर नहीं होगा। अगर आप भाग िेने 
का फैसिा करते  है  तबभी आप ककसी भी समय बबना कारण अध्ययन मे ना भाग िेने के 
मिए स्ितंत्र हैं। 
10. अनुसांधान मे भाग लेने िाले मिीजों की सांख्या 
इस अध्ययन के मिए रोगी से कोई नैदाननक नमूना (जैसे रक्त, मूत्र, र्थूक) एकत्र नहीं ककया 
जाता है, इस अध्ययन में केिि नैदाननक अििोकन ककए जाते हैं। 
 
11. जांच के ललए धन का स्रोत। 
अनुसंिान पररयोजना के मिए रोगी से कोई अनतररक्त शुल्क नहीं मिया जाएगा। दंत 
गिककत्सा के मिए मौजूदा ररयायती शुल्क के अनुसार संस्र्थान द्िारा रोगगयों से शुल्क मिया 
जाएगा 
12.दिा पिीक्षण के मामले में: 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
a) दिा का िासायननक नाम इसके ननमाषण की नतधथ औि बैच नांबि 
b) दिा की प्रािांलभक जैि समकक्ष अध्ययन
 
 /
सांदभष
 
प्रदान की जानी चादहए 
िागू नहीं 
13. जैविक सामग्री के सांभावित ितषमान औि भविष्य के उपयोग 
इस शोि से उत्पन्न डेिा का उपयोग शोि प्रकाशन उद्देश्यों के मिए ककया जा सकता है 
िेककन व्यच्क्तगत और संिेदनशीि व्यच्क्तगत जानकारी की पहिान गोपनीय रिी जाएगी। 
डेिा को ककसी द्वितीयक उद्देश्य के मिए नहीं रिा जाएगा। 
14. जैविक रूप से सांिेदनशील जानकािी की िोज का जोखिम। 
जैविक संिेदनशीि जानकारी को गोपनीय रिा जाएगा। 
15. प्रकाशन क्रकसी भी फोटो औि िांशािली चाटष के सदहत । 
अध्ययन के अंत में सभी जानकारी एक ओर्थडोटिक जनकि में एक सार्थ डाि दीजाएगी और 
पररणाम प्रस्तुत ककया जाएगा । आप के बारे में ककसी भी जानकारी को प्रकामशत करने के 
समय अप का नाम और पता हिा टदया जाएगा। 
16.जांचकताषओां की ल्जम्मेदािी। 
जांिकताक च्जम्मेदारी िेते हैं कक यटद आप इस अध्ययन में हैं तो ककसी भी तरह से इिाज 
पररिनतकत या बद िा नहीं जाएगा। सब के ररकॉडक गोपनीय ररिे जाएगे और ककसी भी बाहरी 
व्यच्क्त को नहीं बताया जाएगा। 
मिीजों के ललए सहमनत पत्र( उम्र 18 औि उससे अधधक) 
 सहमनत 
1. मैं इस अध्ययन में भाग िेने के मिए स्िेच्छा से सहमत हूं 
2. मुझे अध्ययन का उद्देश्य और अन्य वििरण समझाया गया है। मुझे इसमें शाममि प्रकियाओं का पूरा 
वििरण टदया गया है 
3.  मुझे सिाि पूछने का मौका टदया गया है और मेरे सभी सिािों का जिाब मेरी संतुच्ष्ि के मिए टदया 
गया है 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
4. मैं बबना ककसी कारण के ककसी भी समय अध्ययन से पीछे हिने के मिए स्ितंत्र हूं और मेरी गिककत्सा 
देिभाि या कानूनी अगिकार प्रभावित हुए बबना 
5. मैं समझता हूं कक अध्ययन के पररणामों का मूल्यांकन करने के मिए मेरे मेडडकि ररकॉडक में जानकारी 
आिश्यक है। मैं इस जानकारी को उस समझ पर जारी करने के मिए सहमत हूं च्जसे गोपनीय रूप से 
माना जाएगा 
6. मैं इस बात से सहमत हूं कक मुझे इस अध्ययन से संबंगित ककसी भी ररपोिक / दस्तािेज / ककसी अन्य 
माध्यम से नाम से संदमभकत नहीं ककया जाएगा 
7. मुझे अध्ययन से जुड़े रोगगयों और समाज के मिए जोखिम और िाभ के बारे में समझाया गया है 
8. मैं इस बात से सहमत हूं कक यटद मुझे अध्ययन में भाग िेने के पररणामस्िरूप नुकसान हुआ है, तो 
पीआई / सतककता / विश्िविद्यािय द्िारा उपिार नन: शुल्क प्रदान ककया जाएगा। 
9. मैं इस बात से सहमत हूं कक इस अध्ययन के दौरान एकत्र ककए गए आंकड़े को भविष्य में उपयोग के 
मिए संग्रहीत ककया जा सकता है। 
 
मैं स्िेच्छा से उपरोक्त अध्ययन में भाग िेने के मिए सहमत हूं। 
 
अनुमनत दे                                                                                      अनुमनत नहीं दे 
 
प्रनतभागी / अमभभािक का हस्ताक्षर                                                       टदनांक: 
नाम: 
उम्र: 
पता: 
 
 
 
 
 
डॉक्िर / प्रिान अन्िेषक का हस्ताक्षर:                                                    टदनांक: 
 
 
 
 
 
साक्षी का हस्ताक्षर:                                                                              टदनांक 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
 
13 िर्ष से 17 िर्ष की आयु के बच्चों को शालमल किने के ललए हस्ताक्षि पृष्ठ 
1. 
मैं इस बात से सहमत हूं कक मेरा बच्िा स्िेच्छा से इस अध्ययन में भाग 
िे रहा है। 
2. मुझे अध्ययन का उद्देश्य और अन्य वििरण समझाया गया है। मुझे इसमें शाममि प्रकियाओं 
का पूरा वििरण टदया गया है 
3.  मुझे सिाि पूछने का मौका टदया गया है और मेरे सभी सिािों का जिाब मेरी संतुच्ष्ि के मिए 
टदया गया है 
4. 
मुझे पता है कक मेरा बच्िा बबना ककसी कारण के ककसी भी समय 
अध्ययन से पीछे हिने के मिए स्ितंत्र है और मेरी गिककत्सा देिभाि या 
कानूनी अगिकार प्रभावित हुए बबना 
5. 
मैं समझता हूं कक अध्ययन के पररणामों का मूल्यांकन करने के मिए मेरे 
बच्िे के मेडडकि ररकॉडक में जानकारी आिश्यक है। मैं इस जानकारी को उस 
समझ पर जारी करने के मिए सहमत हूं च्जसे गोपनीय रूप से माना जाएगा। 
6. 
मैं इस बात से सहमत हूं कक मेरे बच्िे को इस अध्ययन से संबंगित 
ककसी भी ररपोिक / दस्तािेज / ककसी अन्य माध्यम से नाम से नहीं भेजा 
जाएगा 
7. मुझे अध्ययन से जुड़े रोगगयों और समाज के मिए जोखिम और िाभ के बारे में समझाया गया 
है 
8. 
मैं इस बात से सहमत हूं कक यटद मेरे बच्िे को अध्ययन में भाग िेने के 
पररणामस्िरूप नुकसान हुआ है, तो पीआई / संस्र्थान / विश्िविद्यािय द्िारा 
मुफ्त में उपिार प्रदान ककया जाएगा। 
9. मैं इस बात से सहमत हूं कक इस अध्ययन के दौरान एकत्र ककए गए आंकड़े को भविष्य में 
उपयोग के  
मिए संग्रहीत ककया जा सकता है। 
 
       मैं स्िेच्छा से सहमत हूं कक मेरा बच्िा उपरोक्त अध्ययन में भाग िेगा। 
 
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604                                                                                                                                            
 
 
अनुमनत दे                                                                                      अनुमनत नहीं दे 
 
 
 
 
 
माता-वपता / अमभभािक का हस्ताक्षर 
                                                                                                      टदनांक: 
नाम: 
उम्र: 
पता: 
 
 
बच्िे की सहमनत: --------------------- बच्िे / नाबामिग का नाम) उपरोक्त अध्ययन में भाग िेने 
के मिए सहमत हो गया है 
 
      
 
 
      बच्िे का हस्ताक्षर                                           टदनांक:                  
 
 
 
 
 
डॉक्िर / प्रिान अन्िेषक का हस्ताक्षर:                                                    टदनांक: 
 
 
 
साक्षी का हस्ताक्षर:                                                                              टदनांक 
                                                                                                                  
 

01-11-2021 
 
Oral health related quality of life and clinical outcomes in patients undergoing canine disimpaction- A Randomized Control Trial. 
NCT number: NCT01917604