Quantitative Measurement of ARI

Orthodontic Appliance Complication Clinical Trial

Official title:

Quantitative Measurement of the Adhesive Remnant Index Using Two Different Debonding Techniques: A Split-mouth Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05499923
• Other study ID #: ERC/CMH/LMC/621
• Status: Completed
• Phase: N/A
• 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
• 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

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