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

Sponsor
Saint-Joseph University (Other)
Overall Status
Completed
CT.gov ID
NCT05939102
Collaborator
(none)
25
1
2
18.3
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: v-prep combined with RMGIC for bracket bonding
  • Combination Product: Conventional bracket bonding technique
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Eighteen-month Orthodontic Bracket Survival Rate With the Conventional Bonding Technique Versus RMGIC and V-prep: A Split-mouth RCT
Actual Study Start Date :
Dec 10, 2021
Actual Primary Completion Date :
Jan 20, 2022
Actual Study Completion Date :
Jun 20, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Bracket bonding survival rate [18 months]

    reports of bracket debonding using one of the two bonding techniques

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saint Joseph University Beirut Lebanon 17-5208

Sponsors and Collaborators

  • Saint-Joseph University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Saint-Joseph University
ClinicalTrials.gov Identifier:
NCT05939102
Other Study ID Numbers:
  • USJ-2020-010
First Posted:
Jul 11, 2023
Last Update Posted:
Jul 11, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Saint-Joseph University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2023