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Quantitative Measurement of ARI

Sponsor
CMH Lahore Medical And Dental College (Other)
Overall Status
Completed
CT.gov ID
NCT05499923
Collaborator
(none)
148
Enrollment
1
Location
2
Arms
8.6
Actual Duration (Months)
17.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Debonding
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
148 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Split mouth designSplit mouth design
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The patients were blinded for the technique used in each quadrant and also the outcome assessors were blinded about the technique used for debonding brackets.
Primary Purpose:
Treatment
Official Title:
Quantitative Measurement of the Adhesive Remnant Index Using Two Different Debonding Techniques: A Split-mouth Randomized Clinical Trial
Actual Study Start Date :
Oct 1, 2021
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jun 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Wing method of 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.

Device: Debonding
Debonding of orthodontic brackets with wing or base method with a conventional debonding plier
Active Comparator: Base method of 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.

Device: Debonding
Debonding of orthodontic brackets with wing or base method with a conventional debonding plier

Outcome Measures

Primary Outcome Measures

  1. Adhesive remnant index [6 months]

    Quantitative Measurement of adhesive remnant index by a digital handheld microscope

Secondary Outcome Measures

  1. 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

Other Outcome Measures

  1. Assessor reported outcomes [6 months]

    Corrosion on labial surface of teeth and flush of adhesive noticed by the clinician by visual inspection and reported by yes or no

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haris Khan Lahore Punjab Pakistan 54000

Sponsors and Collaborators

  • CMH Lahore Medical And Dental College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haris Khan, Professor, CMH Lahore Medical And Dental College
ClinicalTrials.gov Identifier:
NCT05499923
Other Study ID Numbers:
  • ERC/CMH/LMC/621
First Posted:
Aug 12, 2022
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Haris Khan, Professor, CMH Lahore Medical And Dental College
Bracket Debonding , Wing method, Base method , ARI

Study Results

No Results Posted as of Aug 12, 2022