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

Jamia Millia Islamia

Status: Active, not recruiting

Conditions: Tooth, Impacted

Treatments: Procedure: open exposure; Procedure: closed exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT01917604

imc25

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 13 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

open exposure and control

Experimental group

Description:

● 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

Treatment:

Procedure: open exposure

closed exposure and control

Experimental group

Description:

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

Treatment:

Procedure: closed exposure