Effectiveness of Methods to Remove Residual Orthodontic Adhevsie

July 5, 2024 updated by: Saja Saeed Mutar, University of Baghdad

The Effectiveness of Methods for Removing Residual Orthodontic Adhesive From Debonded Metal Attachments: A Randomized Clinical Trial

The aim of this study is to compare the clinical efficacy of different residual orthodontic adhesive removing methods for rebonding debonded metal attachments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. To evaluate and compare the bond failure rates of rebonded brackets using two methods to remove the adhesive remnant and comparing them with contralateral teeth.
  2. To evaluate and compare the bond failure rates of rebonded brackets between different quadrants and arches.
  3. To evaluate and compare the bond failure rates of rebonded molar tubes using two methods to remove the adhesive remnant and comparing them with contralateral teeth.
  4. To evaluate and compare the bond failure rates of rebonded molar tubes between different quadrants and arches.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Baghdad., Iraq
        • 2 private dental clinics in Iraq and special center in Karbala.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients need metal fixed orthodontic appliance treatment;
  2. Complete set of permanent dentition with fully erupted teeth on both arches;
  3. Intact teeth and mainly their buccal surfaces are free from caries, fillings, or gingival hyperplasia;
  4. No occlusal interferences that can affect the ideal position of attachments, especially in the lower arch.

Exclusion Criteria:

  1. patients have crown, missing teeth, or craniofacial anomalies.
  2. patients have congenital enamel defects specially their buccal surface.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sandblasted group (T1)
the side of mouth patient that receives fixed orthodontic appliance that renewed by sandblast
Procedure: Recycling orthodontic brackets

T0: The adhesive removal will be performed by high-speed hand piece with tungsten carbide bur. the bur will be changed every five attachments. T1: Control group of T0. T2: The adhesive removal will be performed by sandblasting via Micro-etcher.

T3: Control group of T2.
Placebo Comparator: control group (T3)
the side of mouth patient that receives new fixed orthodontic appliance.
Procedure: Recycling orthodontic brackets

T0: The adhesive removal will be performed by high-speed hand piece with tungsten carbide bur. the bur will be changed every five attachments. T1: Control group of T0. T2: The adhesive removal will be performed by sandblasting via Micro-etcher.

T3: Control group of T2.
Experimental: tungsten bur group (T0)
the side of mouth patient that receives fixed orthodontic appliance that renewed by tungsten bur.
Procedure: Recycling orthodontic brackets

T0: The adhesive removal will be performed by high-speed hand piece with tungsten carbide bur. the bur will be changed every five attachments. T1: Control group of T0. T2: The adhesive removal will be performed by sandblasting via Micro-etcher.

T3: Control group of T2.
Placebo Comparator: control group (T2)
the side of mouth patient that receives new fixed orthodontic appliance.
Procedure: Recycling orthodontic brackets

T0: The adhesive removal will be performed by high-speed hand piece with tungsten carbide bur. the bur will be changed every five attachments. T1: Control group of T0. T2: The adhesive removal will be performed by sandblasting via Micro-etcher.

T3: Control group of T2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of bonding failures will be compared using the chi-square test.
Time Frame: baselines
evaluate and compare the bond failure rates. different quadrants and arches.To evaluate and compare the bond failure rates of rebonded attachments(brackets and molar tubes)using two methods (Tungsten carbide bur and sandblasting)) to remove the adhesive remnant and comparing them with contralateral teeth.
baselines

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The bonding failure between each quadrant will be compared by one way ANOVA.
Time Frame: bsaelines
evaluate and compare the bond failure rates. different quadrants and arches.
bsaelines

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

June 26, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 5, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • recycling orthodontic

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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