Comparison of Precision in Brackets Position in Two Indirect Bonding Materials (IDBmaterials)

July 29, 2022 updated by: Maria Monica Zamora, Fundación Universitaria CIEO

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Polyvinylsiloxane
Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers
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
Active Comparator: Thermal glue
Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfers
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linear mesio-distal position
Time Frame: 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.
2 weeks
Linear occlusal-gingival position
Time Frame: 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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Universitaria CIEO

Investigators

  • Principal Investigator: Maria M Zamora, DDS, Fundación universitaria CIEO - UniCIEO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 30, 2022

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

November 29, 2022

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UniCIEO Indirect bonding

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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