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

NCT05939102 | Completed DMC

• 1 other identifier: USJ-2020-010
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Malocclusion

Keywords

resin-modified glass ionomer; surface preparation; orthodontic bracket

Outcome Measures

Primary Outcomes (1)

• Bracket bonding survival rate

  reports of bracket debonding using one of the two bonding techniques

  18 months

Study Arms (2)

Conventional bracket bonding technique

ACTIVE COMPARATOR

Combination Product: Conventional bracket bonding technique

V-prep combined with RMGIC for bracket bonding

EXPERIMENTAL

Combination Product: v-prep combined with RMGIC for bracket bonding

Interventions

v-prep combined with RMGIC for bracket bonding COMBINATION_PRODUCT

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

V-prep combined with RMGIC for bracket bonding

Conventional bracket bonding technique COMBINATION_PRODUCT

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

Conventional bracket bonding technique

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University

Beirut, 17-5208, Lebanon

Location

Related Publications (2)

• 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.

  PMID: 36547526 BACKGROUND

• 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.

  PMID: 31495756 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Victor Ghoubril, Ms

  Saint-Joseph University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 11, 2023
• Study Start: December 10, 2021
• Primary Completion: January 20, 2022
• Study Completion: June 20, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Locations

LE (1)