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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05499923
Other study ID # ERC/CMH/LMC/621
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date June 21, 2022

Study information

Verified date August 2022
Source CMH Lahore Medical And Dental College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date June 21, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 30 Years
Eligibility 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


Related Conditions & MeSH terms

  • Orthodontic Appliance Complication

Intervention

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

Locations

Country Name City State
Pakistan Haris Khan Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
CMH Lahore Medical And Dental College

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Other Assessor reported outcomes Corrosion on labial surface of teeth and flush of adhesive noticed by the clinician by visual inspection and reported by yes or no 6 months
Primary Adhesive remnant index Quantitative Measurement of adhesive remnant index by a digital handheld microscope 6 months
Secondary Patient reported outcome: Pain 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 6 months
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