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Quantitative Measurement of ARI

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05499923
Enrollment
148
Registered
2022-08-12
Start date
2021-10-01
Completion date
2022-06-21
Last updated
2022-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Appliance Complication

Keywords

Bracket Debonding , Wing method, Base method , ARI

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.

Interventions

DEVICEDebonding

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

Sponsors

CMH Lahore Medical College and Institute of Dentistry
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.

Intervention model description

Split mouth design

Eligibility

Sex/Gender
ALL
Age
12 Years to 30 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Adhesive remnant index6 monthsQuantitative Measurement of adhesive remnant index by a digital handheld microscope

Secondary

MeasureTime frameDescription
Patient reported outcome: Pain6 monthsAfter 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

MeasureTime frameDescription
Assessor reported outcomes6 monthsCorrosion on labial surface of teeth and flush of adhesive noticed by the clinician by visual inspection and reported by yes or no

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026