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OpenTrials
Completed

NCT Number: NCT05499923

Quantitative Measurement of ARI

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

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Key information

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haris Khan

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Debonding

Device

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

Primary outcomes

  1. Adhesive remnant index

    Time frame: 6 months

    Quantitative Measurement of adhesive remnant index by a digital handheld microscope

Secondary outcomes

  1. Patient reported outcome: Pain

    Time frame: 6 months

    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

Other outcomes

  1. Assessor reported outcomes

    Time frame: 6 months

    Corrosion on labial surface of teeth and flush of adhesive noticed by the clinician by visual inspection and reported by yes or no

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

CMH Lahore Medical College and Institute of Dentistry

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2022
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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