NCT05483114

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

August 30, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

Same day

First QC Date

July 29, 2022

Last Update Submit

July 29, 2022

Conditions

Orthodontic Appliance ComplicationMalocclusion

Keywords

indirect bonding

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Polyvinylsiloxane

ACTIVE COMPARATOR

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

Thermal glue

ACTIVE COMPARATOR

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

Interventions

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

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

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

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Maria M Zamora, DDS

    Fundacion universitaria CIEO - Unicieo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria M Zamora, DDS

CONTACT

3214391039mm.zamora@unicieo.edu.co

Claudia Forero, DDS

CONTACT

3158991133cv.forero@unicieo.edu.co

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Split-mouth randomized clinical trial study, with 15 participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 1, 2022

Study Start

August 30, 2022

Primary Completion

August 30, 2022

Study Completion

November 29, 2022

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share