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

NCT ID: NCT05939102

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-10
• Study Completion Date: 2023-06-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional bracket bonding technique

Group Type: ACTIVE_COMPARATOR

Conventional bracket bonding technique

Intervention Type: COMBINATION_PRODUCT

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

V-prep combined with RMGIC for bracket bonding

Group Type: EXPERIMENTAL

v-prep combined with RMGIC for bracket bonding

Intervention Type: COMBINATION_PRODUCT

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

Interventions

v-prep combined with RMGIC for bracket bonding

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

Intervention Type: COMBINATION_PRODUCT

Conventional bracket bonding technique

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saint-Joseph University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor Ghoubril, Ms

Role: PRINCIPAL_INVESTIGATOR

Saint-Joseph University

Locations

Saint Joseph University

Beirut, , Lebanon

Countries

Lebanon

References

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.

Reference Type: BACKGROUND

PMID: 36547526 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31495756 (View on PubMed)

Other Identifiers

USJ-2020-010

Identifier Type: -

Identifier Source: org_study_id