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Comparison of Precision in Brackets Position in Two Indirect Bonding Materials (IDBmaterials)

Primary Purpose

Orthodontic Appliance Complication, Malocclusion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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
Sponsored by
Fundación Universitaria CIEO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthodontic Appliance Complication focused on measuring indirect bonding

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Polyvinylsiloxane

    Thermal glue

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 29, 2022
    Last Updated
    July 29, 2022
    Sponsor
    Fundación Universitaria CIEO
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05483114
    Brief Title
    Comparison of Precision in Brackets Position in Two Indirect Bonding Materials
    Acronym
    IDBmaterials
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2022 (Anticipated)
    Primary Completion Date
    August 30, 2022 (Anticipated)
    Study Completion Date
    November 29, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fundación Universitaria CIEO

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Orthodontic Appliance Complication, Malocclusion
    Keywords
    indirect bonding

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Split-mouth randomized clinical trial study, with 15 participants.
    Masking
    ParticipantCare ProviderOutcomes 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.
    Allocation
    Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Polyvinylsiloxane
    Arm Type
    Active Comparator
    Arm Description
    Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers
    Arm Title
    Thermal glue
    Arm Type
    Active Comparator
    Arm Description
    Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfers
    Intervention Type
    Procedure
    Intervention Name(s)
    Accuracy of indirect bonding of self-ligating brackets made with polyvinylsiloxane transfers
    Intervention Description
    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
    Intervention Name(s)
    Accuracy of indirect bonding of self-ligating brackets made with thermal glue transfers
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Linear mesio-distal position
    Description
    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
    Title
    Linear occlusal-gingival position
    Description
    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

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maria M Zamora, DDS
    Phone
    3214391039
    Email
    mm.zamora@unicieo.edu.co
    First Name & Middle Initial & Last Name or Official Title & Degree
    Claudia Forero, DDS
    Phone
    3158991133
    Email
    cv.forero@unicieo.edu.co
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria M Zamora, DDS
    Organizational Affiliation
    Fundacion universitaria CIEO - Unicieo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison of Precision in Brackets Position in Two Indirect Bonding Materials

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