Orthodontic Appliance ComplicationIDBmaterialsNCT05483114
Comparison of Precision in Brackets Position in Two Indirect Bonding Materials
A study testing 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 people with Orthodontic Appliance Complication and Malocclusion, run by Fundación Universitaria CIEO.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication, Malocclusion
- What is being tested?
- 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2022to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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).
- Conditions
- Orthodontic Appliance Complication, Malocclusion
- Being tested
- Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers, Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfers
- Keywords
- indirect bonding
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfersProcedure or surgery
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
Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfersProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Polyvinylsiloxane | Active comparator | Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers Receives: 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 Receives: Procedure: Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start30 Aug 2022 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion29 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Split-mouth randomized clinical trial study, with 15 participants.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria CIEO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Monica Zamora, Fundación Universitaria CIEO
- Investigators
- Maria M Zamora, DDS, Principal investigator, Fundacion universitaria CIEO - Unicieo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483114
- Sponsor's protocol ID
- UniCIEO Indirect bonding
- Acronym
- IDBmaterials
- Status last verified
- Jul 2022
- First submitted
- 29 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Precision in the Position of Brackets With Two Indirect Bonding Materials: Polyvinylsiloxane and Thermal Glue. Split-mouth Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05483114
- Acronym / sponsor ID
- IDBmaterials / UniCIEO Indirect bonding
- Conditions
- Orthodontic Appliance Complication, Malocclusion
- Keywords
- indirect bonding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fundación Universitaria CIEOUniversity, hospital or other
- Study start
- 30 Aug 2022 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 29 Nov 2022 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth randomized clinical trial study, with 15 participants.
| Arm | Type | Receives |
|---|---|---|
| Polyvinylsiloxane | Active comparator | Procedure: Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfersAccuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers |
| Thermal glue | Active comparator | Procedure: Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfersAccuracy of indirect bonding of self-ligating brackets made with thermal glue transfers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfersThe 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 | Procedure or surgery | Polyvinylsiloxane |
| Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfersThe 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 | Procedure or surgery | Thermal glue |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria M Zamora, DDS principal investigator
Fundacion universitaria CIEO - Unicieo
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Orthodontic Appliance Complication and Malocclusion, run by Fundación Universitaria CIEO.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria M Zamora, DDS (3214391039, mm.zamora@unicieo.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear mesio-distal position (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.