Clinical trial NCT05499923: Quantitative Measurement of ARI
Official title: Quantitative Measurement of the Adhesive Remnant Index Using Two Different Debonding Techniques: A Split-mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Keywords: Bracket Debonding , Wing method, Base method , ARI
Lead sponsor: CMH Lahore Medical College and Institute of Dentistry
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 148
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adhesive remnant index
timeFrame: 6 months
Secondary outcomes:
measure: Patient reported outcome: Pain
timeFrame: 6 months
Other outcomes:
measure: Assessor reported outcomes
timeFrame: 6 months
Locations:
city: Lahore
country: Pakistan
facility: Haris Khan
state: Punjab
Study officials:
References: