Comparison of Precision in Brackets Position in Two Indirect Bonding Materials

NCT ID: NCT05483114

Last Updated: 2022-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-30

Study Completion Date

2022-11-29

Brief Summary

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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

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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).

Conditions

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Orthodontic Appliance Complication Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Split-mouth randomized clinical trial study, with 15 participants.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
A double-blind study will be carried out, where the patient and the operators who will record the results will be blinded. It is not possible to blind the clinician who performs the indirect bonding process. The processing of the registration of the linear measurements and the statistical advisor will be blinded, this will be done by means of codes for each group.

Study Groups

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Polyvinylsiloxane

Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers

Group Type ACTIVE_COMPARATOR

Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers

Intervention Type PROCEDURE

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

Thermal glue

Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfers

Group Type ACTIVE_COMPARATOR

Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfers

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Universitaria CIEO

OTHER

Sponsor Role lead

Responsible Party

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Maria Monica Zamora

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria M Zamora, DDS

Role: PRINCIPAL_INVESTIGATOR

Fundacion universitaria CIEO - Unicieo

Central Contacts

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Maria M Zamora, DDS

Role: CONTACT

3214391039

Claudia Forero, DDS

Role: CONTACT

3158991133

Other Identifiers

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UniCIEO Indirect bonding

Identifier Type: -

Identifier Source: org_study_id

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