Comparison of Precision in Brackets Position in Two Indirect Bonding Materials

Malocclusion Clinical Trial

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Official title:

Comparison of the Precision in the Position of Brackets With Two Indirect Bonding Materials: Polyvinylsiloxane and Thermal Glue. Split-mouth Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05483114
• Other study ID #: UniCIEO Indirect bonding
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: November 29, 2022

Study information

• Verified date: July 2022
• Source: Fundación Universitaria CIEO
• Contact: Maria M Zamora, DDS
• Phone: 3214391039
• Email: mm.zamora[@]unicieo.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: November 29, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Orthodontic Appliance Complication

Intervention

Procedure:
• Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers
The uppethat consists of positioning brackets on a study model and they will be extended to the patient's mouth. .r hemiarch of each patient will be randomly placed to be cemented with a transfer tray made of polyvinylsiloxane thermal glue, by means of the indirect technique
• Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfers
The uppethat consists of positioning brackets on a study model and they will be extended to the patient's mouth. .r hemiarch of each patient will be randomly placed to be cemented with a transfer tray made of polyvinylsiloxane thermal glue, by means of the indirect technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Universitaria CIEO

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linear mesio-distal position	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.	2 weeks
Primary	Linear occlusal-gingival position	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.	2 weeks