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Comparison of Precision in Brackets Position in Two Indirect Bonding Materials

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05483114
Acronym
IDBmaterials
Enrollment
15
Registered
2022-08-01
Start date
2022-08-30
Completion date
2022-11-29
Last updated
2022-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Orthodontic Appliance Complication

Keywords

indirect bonding

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).

Interventions

PROCEDUREAccuracy 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

PROCEDUREAccuracy 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

Sponsors

Fundación Universitaria CIEO
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Linear mesio-distal position2 weeksIt 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 position2 weeksIt 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.

Contacts

Primary ContactMaria M Zamora, DDS
mm.zamora@unicieo.edu.co3214391039
Backup ContactClaudia Forero, DDS
cv.forero@unicieo.edu.co3158991133

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026