Eighteen-month Orthodontic Bracket Survival Rate With the Conventional Bonding Technique Versus RMGIC and V-prep

July 8, 2023 updated by: Saint-Joseph University

Eighteen-month Orthodontic Bracket Survival Rate With the Conventional Bonding Technique Versus RMGIC and V-prep: A Split-mouth RCT

The aim of this study was to evaluate over eighteen months the clinical bonding failure and survival rates of the conventional bonding technique using the Transbond XT (3M Unitek, Monrovia, California, USA) and the RMGIC Fuji Ortho LC (GC Corporation, Tokyo, Japan) prepared with the V-prep. Therefore, one operator using the straight-wire technique bonded two hundred metallic brackets to upper and lower premolars of twenty-five patients requiring an orthodontic treatment. The randomized trial was a single-blind design in a split-mouth comparison. Each patient was randomly allocated one of the two bonding systems for each premolar on each side of the mouth. The bonding and rebonding techniques were standardized throughout the trial and bond failure was recorded each month for a period of eighteen months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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

  • Lebanon
      • Beirut, Lebanon, 17-5208
        • Saint Joseph University

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • require full orthodontic treatment of both arches
  • mild or average overbite and crowding
  • no restorations on the buccal surface of the premolars

Exclusion Criteria:

  • Patients with required extractions in the treatment plan or with poor oral hygiene

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional bracket bonding technique
Combination product: Conventional bracket bonding technique
prepare the tooth with acid-etch, then bond a bracket using resin composite
Experimental: V-prep combined with RMGIC for bracket bonding
Combination product: v-prep combined with RMGIC for bracket bonding
prepare the tooth surface with the V-prep, then bond a bracket with the RMGIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bracket bonding survival rate
Time Frame: 18 months
reports of bracket debonding using one of the two bonding techniques
18 months

Collaborators and Investigators

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

Sponsor

Saint-Joseph University

Investigators

  • Principal Investigator: Victor Ghoubril, Ms, Saint-Joseph University

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)

December 10, 2021

Primary Completion (Actual)

January 20, 2022

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

July 8, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 8, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USJ-2020-010

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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