Quantitative Measurement of ARI

NCT05499923 | Completed DMC

• 1 other identifier: ERC/CMH/LMC/621
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Conditions

Orthodontic Appliance Complication

Keywords

Bracket Debonding , Wing method, Base method , ARI

Outcome Measures

Primary Outcomes (1)

• Adhesive remnant index

  Quantitative Measurement of adhesive remnant index by a digital handheld microscope

  6 months

Secondary Outcomes (1)

• Patient reported outcome: Pain

  6 months

Other Outcomes (1)

• Assessor reported outcomes

  6 months

Study Arms (2)

Wing method of debonding

ACTIVE COMPARATOR

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

Base method of debonding

ACTIVE COMPARATOR

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

Interventions

Debonding DEVICE

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

Base method of debonding; Wing method of debonding

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• CMH Lahore Medical College and Institute of Dentistry: lead

Study Sites (1)

Haris Khan

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

Dental Debonding

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Split mouth design

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: August 12, 2022
• Study Start: October 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 21, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)