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

Dental Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05939102
• Other study ID #: USJ-2020-010
• Status: Completed
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: June 20, 2023

Study information

• Verified date: July 2023
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 20, 2023
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Malocclusion
• Malocclusion

Intervention

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
• Conventional bracket bonding technique
prepare the tooth with acid-etch, then bond a bracket using resin composite

Locations

Country	Name	City	State
Lebanon	Saint Joseph University	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bracket bonding survival rate	reports of bracket debonding using one of the two bonding techniques	18 months