Clinical trial NCT01917604: Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction
Official title: Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction- A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tooth, Impacted
Keywords: Open versus Closed surgical technique
Palatally impacted maxillary canine
Orthodontic disimpaction
Oral health related Quality of life
Lead sponsor: Jamia Millia Islamia
Sponsor class: OTHER
Collaborators: name: Council of Scientific and Industrial Research, India
First posted: 2013-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the null hypothesis that there are no differences in the OHRQOL and clinical outcomes in patients undergoing palatal canine disimpaction using either open or closed surgical method.

Detailed description: The study design will be a unicentric, randomized controlled clinical trial involving 2 parallel groups. The protocol has been approved by local ethics committee of Jamia Millia Islamia and all participants will be provided with an informed consent agreement. The settings will be the orthodontic department of a dental teaching hospital (Faculty of Dentistry, Jamia Millia Islamia). Participants for the trial will be identified from treatment waiting lists and new patient clinics.

Proper randomization procedures and reporting include the following steps.

1. Generation of the random allocation sequence, including details of any restrictions.
2. Allocation concealment.
3. Implementation of the random allocation sequence:

information on who generated the allocation sequence, who enrolled the participants, and who assigned them to their groups.

OPEN SURGICAL EXPOSURE

* Surgically uncover the canine tooth followed by 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 reclosure of the very thick palatal mucosa.
* Surgical excision of the palatal mucosa-standardized using a preformed wire template.
* Coe-pack surgical dressing (GC America Inc, Alsip, IL) will be left in place.
* The patient will be reviewed 10 days later and the surgical pack removed and the bracket bonded and force application started once the tooth has erupted sufficiently for an orthodontic attachment to be glued onto its surface, orthodontic brace treatment is commenced to bring the tooth into line.

CLOSED SURGICAL EXPOSURE

• Surgically uncover the canine tooth and Surgical bone removal exposing the largest diameter of the ectopic canine crown.

* An multipurpose attachment with ligature wire and e chain will be bonded to the palatal or buccal surface of the ectopic canine crown (whichever was the most accessible).
* 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 before, 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 pre-treatment and post treatment (one month after debond) -(Annexure 1 - page 1,2)
2. Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire 24 hrs and 10 days after surgical caniine exposure (Annexure 1 - page 3,4).
3. Measurement of clinical outcomes 3 months post debond (details mentioned in Annexure 2).
4. Maxillary Canine Aesthetic Index (one month after debond) - Annexure 3

Eligibility criteria: Inclusion Criteria:Patients with palatally ectopic maxillary canines who required surgical exposure and orthodontic alignment

* Age 13-25 years Minimal orthodontic problems other than the ectopic canine
* Good oral hygiene and motivated to wear fixed appliances for at least 2 years

Exclusion Criteria:

Compromising medical conditions (patients requiring antibiotic prophylaxis to prevent infective endocarditis)

* 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.

Primary outcomes:
measure: Oral health based Quality of life (Annexure 1; page 1 and page 2)
timeFrame: pre-treatment and 1 month post treatment (average duration of treatment 18 months )
measure: Post- surgical Oral health based Quality of life (24 hours after surgical exposure) (Annexure 1; page 3)
timeFrame: 24 hours after surgical exposure
measure: Post- surgical Oral health based Quality of life (10th day after surgical exposure)(Annexure 1; page 4)
timeFrame: 10th day after surgical exposure
measure: Clinical outcomes - periodontal (Annexure 1; page 5)
timeFrame: Three month post debond
measure: Maxillary canine aesthetic index (Annexure 1; page 7)
timeFrame: one month after debond
Secondary outcomes:
Other outcomes:
Locations:
city: Delhi
country: India
facility: Jamia Millia Islamia
Study officials:
affiliation: Jamia Millia Islamia
name: panchali batra, m.d.s.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parkin NA, Deery C, Smith AM, Tinsley D, Sandler J, Benson PE. No difference in surgical outcomes between open and closed exposure of palatally displaced maxillary canines. J Oral Maxillofac Surg. 2012 Sep;70(9):2026-34. doi: 10.1016/j.joms.2012.02.028. Epub 2012 Jun 6.