Comparison of Precision in Brackets Position in Two Indirect Bonding Materials

Not Applicable

• Conditions: Malocclusion; Orthodontic Appliance Complication
• Interventions: Procedure: Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfers; Procedure: Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers

• Registration Number: NCT05483114
• Lead Sponsor: Fundación Universitaria CIEO

Brief Summary

Objective: To compare the cementation precision of self-ligating brackets between two indirect bonding materials: polyvinylsiloxane and thermal glue.

Methods: Split-mouth randomized clinical trial study, with 15 participants. The study will be divided into two groups, Group 1: Polyvinylsiloxane and Group 2: Thermal glue.

Detailed Description

Patients from the self-ligation clinic who meet the inclusion criteria will be invited to participate and sign the informed consent. For the cementation of the brackets in each patient, the upper arch (right and left) will be divided from the second premolar on the right side to the second premolar on the left side, randomly assigned, to be cemented with a polyvinylsiloxane transfer tray and the other with thermal glue (materials selected for the study).

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-07-29
• Last Update Submitted: 2022-07-29
• Study First Posted: 2022-08-01
• Last Update Posted: 2022-08-01
• Study Start: 2022-08-30
• Primary Completion: 2022-08-30
• Study Completion: 2022-11-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Permanent dentition with the presence of teeth 15-25 with
• Crowding in the upper arch according to Little's irregularity index,
• Teeth with healthy enamel (without hypoplasias, fluorosis, amelogenesis imperfecta),
• Fully erupted teeth

Exclusion Criteria

• Absence of teeth selected for the study or that required premolar extractions before starting alignment and leveling
• Patients with rehabilitation such as crowns, veneers, fractured dentition, atypical morphology
• Teeth whose bracket loosens at the time of the procedure due to failure of the union
• Poor oral hygiene
• Patients with any significant displacement of the tooth that could prevent seating of the transfer tray
• Study models with bubbles.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thermal glue	Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfers	Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfers
Polyvinylsiloxane	Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers	Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers

Primary Outcome Measures

Name	Time	Method
Linear mesio-distal position	2 weeks	It is the difference in the maximum Euclidean distance (two-dimensional plane) between a point mesial and distal of the bracket in the working model and in the patient's tooth.
Linear occlusal-gingival position	2 weeks	It is the difference in the maximum Euclidean distance (two-dimensional plane) between a point occlusal and gingival of the bracket in the working model and in the patient's tooth.