ClinicalTrials.gg
Status unknownNCT05483114IDBmaterialsUpdated Aug 1, 2022

Comparison of Precision in Brackets Position in Two Indirect Bonding Materials

An interventional study of Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers and Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfers in Orthodontic Appliance Complication and Malocclusion, sponsored by Fundación Universitaria CIEO. Status unknown. Per ClinicalTrials.gov, last updated 2022-08-01.

Sponsored by Fundación Universitaria CIEO · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Orthodontic Appliance Complication
  • Malocclusion

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Keywords

  • indirect bonding
03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's planned enrollment of 15 is below the median of 37 across 242 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Fundación Universitaria CIEO is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
15 participants (estimated)

Study arms

  • 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

  • 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

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 weeks

  2. 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.

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2022; primary completion for Aug 2022, 0 months later.

Of 153 non-industry interventional studies with no phase under Malocclusion, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's planned 0 months is below that.

Counting every sponsor, half of 163 studies reached it within 19 months; a quarter within 10 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2022
First posted
Aug 1, 2022
StartEst.
Aug 30, 2022
Primary completionEst.
Aug 30, 2022
CompletionEst.
Nov 29, 2022
Last update
Aug 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05483114
Lead sponsor
Fundación Universitaria CIEO
Responsible party
Maria Monica Zamora (Principal investigator, Fundación Universitaria CIEO) — Principal investigator
First posted
Aug 1, 2022
Start date
Aug 30, 2022 (estimated)
Primary completion
Aug 30, 2022 (estimated)
Completion
Nov 29, 2022 (estimated)
Last update
Aug 1, 2022

Study contacts

Maria M Zamora, DDS
Contact
mm.zamora@unicieo.edu.co
3214391039
Claudia Forero, DDS
Contact
cv.forero@unicieo.edu.co
3158991133
Maria M Zamora, DDS
principal investigator · Fundacion universitaria CIEO - Unicieo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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