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

September 27, 2023 updated by: DR.PANCHALI BATRA, Jamia Millia Islamia

Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction- A Randomized Control Trial.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
      • Delhi, India, 110025
        • Jamia Millia Islamia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: open exposure
the open surgical methods of exposing the canine is compared with control
Experimental: closed exposure and control
raising a flap in the area of impacted canine,bonding an attachment and resuturing the flap
Procedure: closed exposure
closed exposure is compared with control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral health based Quality of life (Annexure 1; page 1 and page 2)
Time Frame: pre-treatment and 1 month post treatment (average duration of treatment 18 months )
to evaluate change in Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both groups
pre-treatment and 1 month post treatment (average duration of treatment 18 months )
Post- surgical Oral health based Quality of life (24 hours after surgical exposure) (Annexure 1; page 3)
Time Frame: 24 hours after surgical exposure
Post- surgical Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both open and closed groups
24 hours after surgical exposure
Post- surgical Oral health based Quality of life (10th day after surgical exposure)(Annexure 1; page 4)
Time Frame: 10th day after surgical exposure
Post- surgical Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both open and closed groups
10th day after surgical exposure
Clinical outcomes - periodontal (Annexure 1; page 5)
Time Frame: Three month post debond
Periodontal outcomes of disimpacted canines accessed clinically and compared for both open and closed groups; contralateral canine of maxillary arch will be control group.
Three month post debond
Maxillary canine aesthetic index (Annexure 1; page 7)
Time Frame: one month after debond
comparision to control side with experimental side of both the groups
one month after debond

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jamia Millia Islamia

Collaborators

Council of Scientific and Industrial Research, India

Investigators

  • Principal Investigator: panchali batra, m.d.s., Jamia Millia Islamia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

August 1, 2013

First Submitted That Met QC Criteria

August 4, 2013

First Posted (Estimated)

August 6, 2013

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • imc25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tooth, Impacted

Clinical Trials on open exposure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe