Comparison of Periodontal Health, Bonding Time and Failure Between Direct and Indirect Fixed Retainer Placement Among Orthodontic Patients - A Modified Split-mouth Randomized Controlled Trial
Phase: NA
Conditions: Orthodontic Treatment
Sponsor: Aga Khan University Hospital, Pakistan

Comparison of Periodontal Health, Bonding 
Time and Failure Between Direct and Indirect 
Fixed Retainer Placement among Orthodontic 
Patients– A Modified Split Mouth Randomized 
Controlled Trial 
 
 
 
 
 
Approved on 14-12-2023 
 
Dental Section, Department of Surgery 
The Aga Khan University Hospital, 
Karach

 

 
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TITLE: Comparison of Periodontal Health, Bonding Time and Failure Between Direct and 
Indirect Fixed Retainer Placement among Orthodontic Patients– A Modified Split-mouth 
Randomized Controlled Trial 
INTRODUCTION: 
Orthodontic treatment is an interplay between applied forces and the biological response of teeth.  
The orthodontic force alters the equilibrium and causes the tooth to move in the desired position.  
However, there is always a chance of relapse.1  An interplay of gingival fibres, periodontal fibers 
and continuous bone growth are responsible for teeth returning to their original positions.2  
Therefore, retention of teeth in their corrected position is necessary for every orthodontic patient.  
Sperry and Abdulla.3 attempted retention of teeth after space closure using a fixed retainer in which 
they found the use of direct bonding material to place the retainer in the mouth conservative and 
non-invasive.   
Fixed retainers forego the need for compliance and are invisible since they are bonded to the 
lingual surfaces of teeth but in the presence of these retainers, teeth become more susceptible to 
plaque accumulation.4  Heier et al.5 compared the periodontal implications of fixed and removable 
retainers using plaque and calculus indices.  He reported that more plaque and calculus was present 
on teeth retained with fixed retainer.   
There are two ways of placement of fixed retainers, either directly placed intra orally after prior 
fabrication on a cast or indirectly placed utilizing a cast on which the retainer is placed using 
composite pads and then transferred into the mouth using a silicon tray.6  The stability of retainers 
is of prime importance for maintaining the correct position of teeth in the long run.7  Egli et al.8 
compared the failure and posttreatment stability of both placement techniques in mandibular arch 
and found that there was no difference in the risks of failure between mandibular retainers bonded 
with direct (DB) and indirect methods. (IDB)  Bovali et al.9 compared the placement time and 
number of failures of fixed retainers bonded via DB and IDB methods and found that the bonding 
time is significantly shorter for DB along with a higher number of failures using the IDB method.   

 
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Levin et al.10 also assessed the association of orthodontic treatment and fixed retention with 
gingival health by examining gingival recession, probing depth, and bleeding on probing of 
anterior teeth.  They found the probing depth to be 1.90 ± 0.2 mm, gingival recession to be 0.06 ± 
0.02 mm and 20.8% of all sites showed bleeding on probing.  He also found that localized lingual 
gingival recession was significantly greater in teeth with fixed retainers (0.09 ± 0.2 mm) compared 
to teeth with no fixed retainers (0.01 ± 0.1 mm); p < 0.05.   
Many people remain cautious of brushing on anterior teeth with retainers because of fear of 
breakage resulting in more plaque deposits on these teeth and therefore, requiring more scaling 
visits.  The time taken for bonding the direct retainers during outpatient clinics can affect the 
duration of debonding appointment which is already a lengthy procedure.  Thus, its important to 
assess the periodontal health, bonding time and stability of both maxillary and mandibular fixed 
retainers placed using DB in one arch and IDB in the other arch in patients who underwent 
orthodontic treatment.   
RATIONALE: 
The placement technique of retainers in both maxillary and mandibular arches can influence the 
time taken for bonding the retainer in the mouth of a patient which can in turn affect the patient´s 
response to the procedure.  The different placement techniques can influence the stability of the 
retainer wire on teeth and the maintenance of periodontal health during the retention period.  
Therefore, it is essential to know which technique is better suited for placement and its influence 
on periodontal health so that in the future it helps clinicians save their time during placement of 
retainers while benefiting the patients.  To our knowledge, this will be the first study both locally 
and internationally that will include an assessment of periodontal health, time duration of 
placement and stability of fixed retainer in the maxillary arch as well.  Three months period is 
sufficient for assessment of periodontal health and failure of retainer, long term studies can be at 
a risk of attrition bias.   

 
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OBJECTIVES: 
The objectives of this study are: 
• The primary objective of this study is to compare the failure of fixed retainers which are 
bonded either through direct method or indirect method on patients undergoing orthodontic 
debonding through a modified split-mouth technique over a period of three months.   
• The secondary objective of the study is to assess the amount of time taken during placement 
of retainers via both direct and indirect bonding of fixed retainers and periodontal health 
of patients undergoing orthodontic debonding through a modified split-mouth technique 
using mean values for plaque index, gingival index, calculus index follow up appointments 
over a period of three months.   
OPERATIONAL DEFINITIONS: 
Fixed Retainer11:  
Fixed retainers consist of a twisted, flexible wire placed over and bonded to the lingual surface of 
anterior teeth.   
Plaque and Calculus Indices:12 (Annexure A) 
Plaque index is a grading system used to assess the amount of plaque present at the gingival 
margins and helps in assessing oral health.  Calculus index is also a grading system used to assess 
the amount of calculus present on gingiva.  These are measurement indices which consist of four 
grades namely Grade 0, 1, 2, and 3.  The increase in grade indicates the increased amount of plaque, 
calculus along the gingiva.  Grade 0 denotes no plaque, calculus deposits, grade 1 denotes thin 
layer of plaque, calculus deposits, grade 2 denotes moderate layer of plaque, calculus deposits, 
grade 3 denotes abundant layer of plaque, calculus deposits. 
Gingival Index:12 (Annexure B) 
Gingival index is a grading system that is used to assess the health of the gingiva.  It consists of 
four grades namely Grade 0, 1, 2, and 3.  The increase in grade indicates the compromised health 

 
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of gingiva.  Grade 0 indicates no gingival inflammation, grade 1 indicates mild inflammation, 
grade 2 indicates moderate inflammation and grade 3 indicates severe inflammation. 
Retainer Failure:13 
Detachment of the retainer wire either at the wire-composite interface or at the adhesive-enamel 
interface with either movement of teeth or no movement of teeth into a new position.  
Periodontal Health:14 
A state free from inflammatory periodontal disease. 
 
 

 
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Modified Split-mouth Technique: 
A randomized control trial in which experimental and control interventions are randomly allocated 
to different areas in the oral cavity.  In our study, experimental and control interventions will be 
randomly allocated to the upper and lower dental arches.   
 
 HYPOTHESIS: 
• Null Hypothesis: There is no difference in placement technique of fixed retainers that can 
influence the failure of fixed retainers.   
• Alternate Hypothesis: There is a 54% difference in placement technique of fixed retainers 
that can influence the failure of fixed retainers. 
 

 
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MATERIAL & METHODS: 
Study Design: A modified split-mouth randomized controlled trial  
Settings: Department of Surgery, Dental clinics at the Aga Khan University Hospital. 
Study Duration: Minimum six months after ethical review committee (ERC) approval, two 
months will be used for recruitment of participants in this study. 
SAMPLE SIZE:  
The size of sample was measured using Open-epi software by using the findings of Gokce et al.15, 
keeping α as 5%, the power of study as 80% and confidence level at 95%.  To calculate sample 
size, we used the mean and standard deviation values of gingival index at one week interval (0.54 
± 0.64) and (1.02 ± 0.67) for two different bonding techniques i.e direct and indirect, of fixed 
retainer placement.  A sample size of 30 was achieved in each group accounting for the total sample 
size of 60.   
Sampling Technique: Non-probability consecutive sampling 
Sample Selection:  
Inclusion Criteria: 
• Patients aged between 18 - 40 years 
• Patients who read, write and understand English language 
• Patients undergoing fixed orthodontic treatment  
• Patients with good oral hygiene, with grade 1 or below on plaque and gingival indices at 
the time of debonding of brackets. 
• All patients who will sign the informed consent form  
Exclusion Criteria:  

 
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• Patients with periodontal disease 
• Patients with any systemic disease 
• Pregnant or nursing females 
• Patients who cannot come for follow up appointments for a retainer check up 
 
DATA COLLECTION PROCEDURE: 
Before the initiation of the study, ethical approval will be taken from the institutional Ethical 
Review Committee of AKUH.  This study will be carried out as per guidelines of the World 
Medical Association’s Declaration of Helsinki and the principles of Good Clinical Practice (GCP).  
Any modifications in the protocol will be re-submitted to the ERC.  The study will be conducted 
in compliance with regulations and a copy of the final study protocol will be submitted to ERC.  
All participants will be given the choice to either accept or refuse their inclusion in the study after 
providing them with complete detailed information.  Only those patients signing the informed 
consent (Annexure E) will be recruited as study participants.  All the data recorded of patients 
will remain confidential.  Access will be provided to no one except the investigators.  Participants’ 
names and identities will remain undisclosed; however, data may be seen by ERC or any local 
regulatory body.  Data will be saved for 15 years as per regulatory requirements and institutional 
guidelines.   
Participants will be assigned to one of the two study groups using a computer-generated 
randomization list using a random permuted block sampling of 6.  The investigators of the study 
will not be blinded.  The recruitment of the patients will be performed by the investigator who will 
explain the objective, the two arms of the study and the allocation to the participants.  Patients will 
be recruited by principal investigator Dr. Rashna and co-investigator Dr. Fizzah on the basis of the 
above-mentioned inclusion and exclusion criteria.  A proper thorough history and examination will 
be taken by the principal investigator and co-investigator for the purpose of appropriate 

 
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recruitment of patients.  Sequentially numbered, opaque, sealed envelopes method will be 
implemented for allocation concealment, which will conceal the sequence until interventions are 
being assigned.  Allocation of one of two retainer placement techniques will be assigned using 
closed sealed envelopes.  Randomization will be done by closed sealed envelopes.  The 
randomization will be performed by CTU.  The study investigators and patients will not be blinded.  
The eligible upper and lower arches in each subject will be randomized to one of two groups at a 
1:1 allocation ratio. Randomization will aid in minimizing selection bias.  Envelopes must be 
stored in a secure place and opened one by one, only after the subject has been found eligible to 
be randomized.   
 
A fixed retainer wire will be placed either through direct method or indirect method on randomely 
selected either of the maxillary and mandibular teeth of orthodontic patients after debonding 
procedure.  All the measurements will be recorded by the investigator on a plaque index 
(Annexure A), gingival index (Annexure B) and calculus index (Annexure C).   
Data will be collected on an organized study proforma (Annexures D).  The patients will be 
recruited from the Dental clinics, AKUH.  All patients who will sign the informed consent form 
(Annexure E) will receive detailed information regarding the study.  Data will be collected at 
three points in time.  First, at the time of placement of retainer (T-0), their periodontal health will 
be recorded on the chart using the plaque, calculus and gingival indices and bonding time will be 
recorded using a timer. At the follow-up appointments at 1 month (T-1), 3 months (T-2), retainer 
breakage, gingival and periodontal health findings will be assessed clinically.   
 
Study groups: 
The patients will be screened using the inclusion and exclusion criteria by the investigator.  Plaque 
will be assessed using a Community Index of Periodontal Treatment Needs (CPITN) probe before 

 
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bonding at T-0, T-1, and T-2.  Measurements will be taken for the plaque and gingival indices and 
bonding time will be assessed using a timer.  Retainer failures and periodontal health will be 
assessed at the follow-up appointments.   
Group A (Intervention): Indirect placement of retainer (first making of retainer in lab and then 
it´s transfer from the cast onto the teeth via silicon key.)   
Group B (Control): Direct placement of retainer ( no prior lab work).   
The participants will receive routine instructions for oral hygiene maintenance and care of the 
appliance verbally.   
The investigator will unseal the envelope from the CTU, containing information regarding the 
intervention to be used on the participants based on randomization.   
 
Retainers’ management: 
Routine oral hygiene maintenance and retainer management instructions will be given to each 
recruit.  The participants will be advised to not bite from their front teeth as it may make retainer 
wire susceptible to breakage.  In case, patient feels wire has moved, tooth has moved or wire is 
hindering chewing and irritating soft tissues such as tongue, gingiva, patients are advised to 
report to orthodontic clinics for timely repair of retainer wire. 
Interim Analysis/ Stopping Rules: 
Interim analysis will be run once after achievement of data collection of 50% of sample size.  On 
the basis of results, it will be decided whether the study will be continued.  In case of more than 
54% significant difference in failure of fixed retainers, and significant difference in periodontal 
health and bonding time in two different bonding techniques of fixed retainers, the study will be 
stopped. 
 
 

 
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DATA ANALYSIS:  
Data will be entered and analyzed in SPSS for Windows (version 23.0, SPSS Inc. Chicago).  
Frequencies and proportions will be reported for categorical variables such as gender.  The 
Shapiro-Wilk test will be used to check the normality of the data.  Descriptive statistics, such as 
means and standard deviations for normally distributed or median and interquartile range (IQR) 
for non-normally distributed data will be reported for all baseline clinical factors such as age, 
gender, type of malocclusion, duration of retainer placement since two different methods are used. 
Further, gingival and periodontal health may modify/effect the survival of retainers.  Repeated 
measures Anova will be used for the pairwise comparison at baseline, one month and two months 
follow up.  Independent sample t-test will be used for the comparison between the two groups to 
compare the values between both groups at T-0, T-1, and T-2.  Univariate Cox regression analysis 
will be used to assess the influence of factors such as age, gender, and type of malocclusion on 
periodontal health and retainer failures.  Significant variables at univariate level will be taken to 
the multivariable regression.  Cox proportional hazard regression will be run for survival analysis 
to assess the survival time of both, DB and IDB.  The significance level will be kept at p ≤ 0.05 
and confidence level will be kept at 95%.   
Data management and confidentiality: 
Confidentiality regarding patient information will be strictly followed.  Except investigators 
nobody will have access to patient information.  There will be no disclosure at any time of 
participants’ name and identity.  However, the data may be seen by ERC, or any local regulatory 
body for monitoring and audit purpose.  As per GCP and other guidelines, data will be retained 
for 10 years. 
Publication policy/plan: 
For publication, the anonymized data will be utilized, and it could be presented in either national 
or worldwide forum.  

 
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Data monitoring and quality assurance:  
Study PI will randomly check the data for accuracy and completeness on ongoing basis. 
Ethical considerations: 
Before the initiation of the study, ethical approval will be taken from the institutional Ethical 
Review Committee of AKUH.  This study will be carried out as per guidelines of the World 
Medical Association’s Declaration of Helsinki and the principles of Good Clinical Practice (GCP).  
Any modifications in the protocol will be re-submitted to the ERC.  The study will be conducted 
in compliance with regulations and a copy of the final study protocol will be submitted to ERC.  
All participants will be given the choice to either accept or refuse their inclusion in the study after 
providing them with complete detailed information.  Only those patients signing the informed 
consent (Annexure E) will be recruited as study participants.  All the data recorded of patients 
will remain confidential.  Access will be provided to no one except the investigators.  Participants’ 
names and identities will remain undisclosed; however, data may be seen by ERC or any local 
regulatory body.  Data will be saved for 10 years as per GCP and institutional guidelines.   
Possible risks or benefits:  
There is a risk of breakage of retainer wire.  In case of retainer breakage, there can be a risk of 
flexible retainer wire irritating the gums and hinder chewing and for this reason patients are 
advised to come to dental clinics for timely repair of retainer wire.   
References: 
1. Li Y, Jacox LA, Little SH, Ko CC. Orthodontic tooth movement: The biology and clinical 
implications. Kaohsiung J Med Sci. 2018;34:207-14.   
2. Johnston CD, Littlewood SJ. Retention in orthodontics. Br Dent J. 2015;218:119-22.   
3. Sperry TP, Abdulla A. Physiologic permanent retention following space closure. Am J Orthod. 
1982;82:42-4.   

 
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4. Arn ML, Dritsas K, Pandis N, Kloukos D. The effects of fixed orthodontic retainers on 
periodontal health: a systematic review. Am J Orthod Dentofacial Orthop. 2020;157:156-64.   
5. Heier EE, De Smit A, Wijgaerts IA, Adriaens PA. Periodontal implications of bonded versus 
removable retainers. Am J Orthod Dentofacial Orthop. 1997;112:607-16.   
6. Korkmaz YN, Arslan S. Transfer accuracy of four different lingual retainer transfer methods 
using digital orthodontic models: an in vivo comparative study. Angle Orthod. 2021;91:778-
85.   
7. Moda LB, da Silva Barros AL, Fagundes NC, Normando D, Maia LC, dos Anjos Mendes SM. 
Lower fixed retainers: bonded on all teeth or only on canines? a systematic review.  Angle 
Orthod. 2020;90:125-43.   
8. Egli F, Bovali E, Kiliaridis S, Cornelis MA. Indirect vs direct bonding of mandibular fixed 
retainers in orthodontic patients: comparison of retainer failures and posttreatment stability. a 
2-year follow-up of a single-center randomized controlled trial. Am J Orthod Dentofacial 
Orthop. 2017;151:15-27.   
9. Bovali E, Kiliaridis S, Cornelis MA. Indirect vs direct bonding of mandibular fixed retainers 
in orthodontic patients: a single-center randomized controlled trial comparing placement time 
and failure over a 6-month period. Am J Orthod Dentofacial Orthop. 2014;146:701-8.   
10. Levin L, Samorodnitzky‐Naveh GR, Machtei EE. The association of orthodontic treatment and 
fixed retainers with gingival health. J Periodontol. 2008;79:2087-92.   
11. Rinchuse DJ, Miles PG, Sheridan JJ. Orthodontic retention and stability: a clinical perspective. 
J Clin Orthod. 2007;41:125-32.   
12. Knaup I, Wagner Y, Wego J, Fritz U, Jäger A, Wolf M. Potential impact of lingual retainers 
on oral health: comparison between conventional twistflex retainers and CAD/CAM fabricated 
nitinol retainers. J Orofac Orthop. 2019;80:88-96.   
13. Iliadi A, Kloukos D, Gkantidis N, Katsaros C, Pandis N. Failure of fixed orthodontic retainers: 
a systematic review. J Dent. 2015;43:876-96.   

 
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14. Lang NP, Bartold PM. Periodontal health. J Periodontol. 2018;89:9-16. 
15. Gökçe B, Kaya B. Periodontal effects and survival rates of different mandibular retainers: 
comparison of bonding technique and wire thickness. Eur J Orthod. 2019;41:591-600. 
 
 

 
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Annexure: Proforma 
TITLE: Comparison of Periodontal Health, Bonding Time and Failure Between Direct and 
Indirect Fixed Retainer Placement among Orthodontic Patients – A Modified Split-mouth 
Randomized Controlled Trial 
Our team is conducting a clinical trial to compare the health of your gums, time taken for 
placement of retainer wire and breakage of fixed retainer wire placed either directly by just 
placing the wire directly on teeth or indirectly by first making it in lab and then transferring it 
from the cast onto the teeth.  Health of your gums will be assessed  using plaque and gingival 
indices.  Kindly read the form thoroughly and decide if you want to participate in this study.  In 
case of participation, you must sign the informed consent form.  In case of any query, you can 
ask for an explanation.   
 
Date:   
 
 
 
 
 
 
            Version:  
Study ID: 
___________  
 
 
 
 
Gender:  
 
 
Age:__ _________ 
 
 
 
 
 
Group: 
🖉 Direct retainer  
🖉 Indirect retainer  
At the time of placement of retainer T0 
Type of Placement 
Bonding 
Time 
Plaque 
Score 
Gingival 
Score 
Calculus 
Score 
Number of 
Breakages 
 Direct 
 
 
 
 
 

 
17 
 
 
 
 
 
Indirect 
 
 
 
 
 
 
Investigator sign__________ 
Date_____________ 
Possible risks:  
There is a risk of breakage of retainer wire.  In case of retainer breakage, there can be a risk of 
flexible retainer wire irritating the gums and hinder chewing and for this reason you are advised 
to not bite anything from from teeth and maintain proper oral hygiene through brushing and 
flossing twice a day.  In case of breakage, come right away to dental clinics for timely repair of 
retainer wire.   
 
 

 
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Date:   
 
 
 
 
 
 
            Version:  
Study ID: 
___________  
 
 
 
 
Gender:  
 
 
Age:__ _________ 
 
 
 
 
 
Group: 
🖉 Direct retainer  
🖉 Indirect retainer  
At the time of one month follow up of retainer T1 
Type of Placement 
Plaque 
Score 
Gingival 
Score 
Calculus 
Score 
Number of 
Breakages 
 Direct 
 
 
 
 
Indirect 
 
 
 
 
 
Investigator sign__________ 
Date_____________ 
 
 
 

 
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Date:   
 
 
 
 
 
 
            Version:  
Study ID: 
___________  
 
 
 
 
Gender:  
 
 
Age:__ _________ 
 
 
 
 
 
Group: 
🖉 Direct retainer  
🖉 Indirect retainer  
At the time of three months follow up of retainer T2 
Type of Placement 
Plaque 
Score 
Gingival 
Score 
Calculus 
Score 
Number of 
Breakages 
 Direct 
 
 
 
 
Indirect 
 
 
 
 
 
Investigator sign__________ 
Date_____________ 
 
 
 

 
20 
 
 
 
 
 
 
Annexure E: Informed Consent Form 
Project Information 
TITLE: Comparison of Periodontal Health, Bonding Time and Failure Between Direct and 
Indirect Fixed Retainer Placement among Orthodontic Patients – A Modified Split-mouth 
Randomized Controlled Trial 
ERC Project No: 
Principal investigator: Dr. Rashna Firoze Aga 
Location: Section of Orthodontics, Department of Surgery. The Aga Khan University Hospital 
Co-investigator: Dr. Fizzah Ikram 
Location: Section of Orthodontics, Department of Surgery. The Aga Khan University Hospital 
Version and Date: 
Sponsor: The Aga Khan University Hospital 
Organization: The Aga Khan University Hospital 
Phone: 021-34930051 
 
 
 
 
 
 
 
INFORMATION SHEET 
Our team is conducting a clinical trial to compare the health of your gums, time taken for 
placement of retainer wire and breakage of fixed retainer wire placed either directly by just 
placing the wire directly on teeth or indirectly by first making it in lab and then transferring it 

 
21 
 
 
 
 
 
from the cast onto the teeth.  Health of your gums will be assessed  using plaque and gingival 
indices.  Kindly read the form thoroughly and decide if you want to participate in this study.  In 
case of participation, you must sign the informed consent form.  In case of any query, you can 
ask for an explanation.   
Purpose of this research study:  
This study aims to compare the gum health, time taken for placement of retainer wire and 
breakage of fixed retainer wire placed either directly onto teeth or indirectly by first making it in 
lab and then transferring it from cast onto the teeth. Your participation will help us find the 
technique better suited for placement of fixed retainers after orthodontic treatment.   
Procedures:  
Your gum health will be assessed using probes and indices at the time of placement of retainer, 
during follow up appointments at one month and then three months later.  Two retainers will be 
placed in your upper and lower teeth.  However, in one jaw the retainer will be placed directly 
and in the other jaw of your mouth the retainer will be placed which was first made in laboratory 
and it will be transferred to your teeth via a transfer tray.  Selection of jaws for direct and indirect 
placement of retainers will be random. 
Possible risks:  
There is a risk of breakage of retainer wire.  In case of retainer breakage, there can be a risk of 
flexible retainer wire irritating the gums and hinder chewing and for this reason you are advised 
to not bite anything from from teeth and maintain proper oral hygiene through brushing and 
flossing twice a day.  In case of breakage, come right away to dental clinics for timely repair of 
retainer wire.  Retainer repair and management is part of the package of orthodontic treatment, 
hence, no additional cost exists for this purpose.   
Financial considerations:  
There is no financial compensation for your participation in this research.   
Incentive:  
There will be no incentives for your participation in this study.  
Adverse events:  
Placement of retainer wire on anterior teeth is a routine form of keeping the teeth in their 
corrected possible.  It is essential that a retainer wire holds the teeth in their new position until 

 
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soft tissues adapt to this new position, therefore, other than the risk of breakage of retainer wire, 
there are no known adverse events related to placement of retainers.   
Subject withdrawal:  
Your participation in this study is voluntary, and you may withdraw from the study at any point 
due to any valid reason if you wish to do so.  This would not affect your treatment or routine 
care.  
Available sources of information:  
Any further questions you have about this study will be answered by: 
Principal Investigator: 
Name: Dr. Rashna Firoze Aga 
Phone Number: 0333-5141026 
 
Any questions you may have about your rights as a research subject will be answered by: 
 
Name: Dr. Fizzah Ikram 
Phone Number: 0343-0204809 
 
In case of a research-related emergency, call:  
 
Day Emergency Number: 
 
Night Emergency Number: 

 
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AUTHORIZATION 
I have read and understand this consent form, and I volunteer to participate in this research study.  
I understand that I will receive a copy of this form.  I voluntarily choose to participate, but I 
understand that my consent does not take away any legal rights in the case of negligence or other 
legal fault of anyone who is involved in this study.   
Name of participant (Printed or Typed): 
Date: 
 
Signature of participant: 
Date: 
 
Signature of Principal Investigator: 
Date: 
 
Name and Signature of person obtaining consent: 
Date: 
 
 

 
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For Participants unable to read 
 
Witness:  
I have witnessed the accurate reading of the consent form to the potential participants, and the 
individual has had the opportunity to ask questions.  I confirm that the individual has given 
consent freely.   
Witness Name: _____________________        Participant’s Thumb Print: __________________ 
Signature:  
 
 
 
 
 
Date:  
 
 
 
 
 
 
 
 
 
 

 
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