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OpenTrials
Completed

NCT Number: NCT05939102

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

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.

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Key information

Conditions

Dental Malocclusion Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph University

Beirut, 17-5208, Lebanon

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Conventional bracket bonding technique

Combination Product

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

Primary outcomes

  1. Bracket bonding survival rate

    Time frame: 18 months

    reports of bracket debonding using one of the two bonding techniques

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 11, 2023
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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