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

Primary Purpose

Dental Malocclusion

Status

Completed

Phase

Not Applicable

Locations

Lebanon

Study Type

Interventional

Intervention

v-prep combined with RMGIC for bracket bonding

Conventional bracket bonding technique

About this trial

This is an interventional treatment trial for Dental Malocclusion focused on measuring resin-modified glass ionomer, surface preparation, orthodontic bracket

Eligibility Criteria

12 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Saint Joseph University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional bracket bonding technique

V-prep combined with RMGIC for bracket bonding

Arm Description

Outcomes

Primary Outcome Measures

Bracket bonding survival rate

reports of bracket debonding using one of the two bonding techniques

Secondary Outcome Measures

Full Information

NCT ID

NCT05939102

First Posted

June 30, 2023

Last Updated

July 8, 2023

Sponsor

Saint-Joseph University

1. Study Identification

Unique Protocol Identification Number

NCT05939102

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

December 10, 2021 (Actual)

Primary Completion Date

January 20, 2022 (Actual)

Study Completion Date

June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Saint-Joseph University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Malocclusion

Keywords

resin-modified glass ionomer, surface preparation, orthodontic bracket

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional bracket bonding technique

Arm Type

Active Comparator

Arm Title

V-prep combined with RMGIC for bracket bonding

Arm Type

Experimental

Intervention Type

Combination Product

Intervention Name(s)

v-prep combined with RMGIC for bracket bonding

Intervention Description

prepare the tooth surface with the V-prep, then bond a bracket with the RMGIC

Intervention Type

Combination Product

Intervention Name(s)

Conventional bracket bonding technique

Intervention Description

prepare the tooth with acid-etch, then bond a bracket using resin composite

Primary Outcome Measure Information:

Title

Bracket bonding survival rate

Description

reports of bracket debonding using one of the two bonding techniques

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victor Ghoubril, Ms

Organizational Affiliation

Saint-Joseph University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saint Joseph University

City

Beirut

ZIP/Postal Code

17-5208

Country

Lebanon

12. IPD Sharing Statement

Citations:

PubMed Identifier

36547526

Citation

Ghoubril V, Changotade S, Lutomski D, Ghoubril J, Chakar C, Abboud M, Hardan L, Kharouf N, Khoury E. Cytotoxicity of V-Prep Versus Phosphoric Acid Etchant on Oral Gingival Fibroblasts. J Funct Biomater. 2022 Nov 28;13(4):266. doi: 10.3390/jfb13040266.

Results Reference

background

PubMed Identifier

31495756

Citation

Ghoubril V, Ghoubril J, Khoury E. A comparison between RMGIC and composite with acid-etch preparation or hypochlorite on the adhesion of a premolar metal bracket by testing SBS and ARI: In vitro study. Int Orthod. 2020 Mar;18(1):127-136. doi: 10.1016/j.ortho.2019.07.003. Epub 2019 Sep 5.

Results Reference

background

Learn more about this trial

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

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