Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Tooth, Impacted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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open exposure and control

● surgically uncover the canine tooth and bone removal exposing the largest diameter of the ectopic canine crown make a window in the palatal soft tissue and bond bracket after 10 days

Group Type EXPERIMENTAL

open exposure

Intervention Type PROCEDURE

the open surgical methods of exposing the canine is compared with control

closed exposure and control

raising a flap in the area of impacted canine,bonding an attachment and resuturing the flap

Group Type EXPERIMENTAL

closed exposure

Intervention Type PROCEDURE

closed exposure is compared with control

Interventions

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open exposure

the open surgical methods of exposing the canine is compared with control

Intervention Type PROCEDURE

closed exposure

closed exposure is compared with control

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes