Quantitative Measurement of ARI

Not Applicable

Completed

• Conditions: Orthodontic Appliance Complication
• Interventions: Device: Debonding

• Registration Number: NCT05499923
• Lead Sponsor: CMH Lahore Medical And Dental College

Brief Summary

A crucial step at end of debonding is to evaluate the site of bond failure. An accurate assessment of the site of bond failure will allow the clinician to select an optimum method for adhesive remnant removal from the enamel surface.

The aim of this study is to do a randomized clinical trial to measure adhesive remanent index quantitively after debonding with wing and base method of debonding

Detailed Description

After informed consent data would be collected from patients who are undergoing debonding of orthodontic brackets after comprehensive orthodontic treatment of at least 2 years. Only the cases which have no loose anterior upper and lower brackets for the last 6 months would be randomly allocated to one of the two sides in each arch for debonding with a specific technique. A protocol of block randomization would be followed for this study. Debonding of brackets would be done either by wing or base method in a split fashion after removal of orthodontic wires. The patient would be explained that both methods are conventional used and are safe for debonding. After debonding each bracket the patient would be asked for the level of pain he felt during the debonding of that specific bracket. The patient will explain the pain level on a scale of 0-10 with 0 referring to no pain while 10 referring to maximum pain. After debonding a digital microscope (Supereyes) would be used along with plastic tubing for taking the adhesive remanent pictures intraorally from the labial surface of teeth. The plastic tubing would have a calibrated scale attached to it. For each new patient, a new tubing or disinfected tubing would be used. The available data would be measured extra orally on a computer-based software (ImageJ). Variable like age, gender, oral hygiene, ARI, side of adhesive flush, and pain would be analyzed.

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-21
• Study First Submitted: 2022-06-21
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-10
• Last Update Submitted: 2022-08-10
• Study First Posted: 2022-08-12
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• All the patients undergoing comprehensive orthodontic treatment by fixed orthodontics
• No reporting of bracket failure in the last 6 months.
• Same company metal brackets used.
• Same adhesive used with same bonding protcol

Exclusion Criteria

• Syndromic patient
• An episode of bracket failure in the last six months
• Short-term orthodontic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wing method of debonding	Debonding	In this method after removal of the orthodontic wire, each bracket would be gripped mesiodistally by a conventional bracket debonding plier at the level of wings and a squeezing force would be applied.
Base method of debonding	Debonding	In this method after removal of the orthodontic wire, each bracket would be gripped mesiodistally by a conventional bracket debonding plier at the level of the bracket base and a squeezing force would be applied.

Primary Outcome Measures

Name	Time	Method
Adhesive remnant index	6 months	Quantitative Measurement of adhesive remnant index by a digital handheld microscope

Secondary Outcome Measures

Name	Time	Method
Patient reported outcome: Pain	6 months	After debonding each bracket patient will score the pain level on a scale of 0-10 with 0 referring to no pain while 10 referring to maximum pain

Trial Locations

Locations (1)

Haris Khan; 🇵🇰 Lahore, Punjab, Pakistan