SEM Evaluation of the Quantity of microRepair® on Resin Composite Surfaces: an in Vivo Randomized Clinical Trial.

May 10, 2021 updated by: Andrea Scribante, University of Pavia

SEM Evaluation of the Quantity of microRepair® Contained in Biorepair Total Protection Toothpaste Residue on Composite Surfaces of Orthodontic Buttons: an in Vivo Randomized Clinical Trial.

The aim of this study is to evaluate the quantity of Biorepair Total Protection toothpaste on composite surfaces inside oral cavity. Three orthodontic lingual buttons are bonded on the vestibular surfaces of upper right premolars (1.4 and 1.5) and upper right first molars (1.6) of volunteers. A composite resine is applied upon them. Then, after 7 days, 1.4 button will be debonded; after 15 days, 1.5 button are debonded; in the end, after 30 days the last button (1.6) is debonded. The buttons will be stored in sterile environment and then sent to laboratory for SEM evaluation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Orthodontic buttons are bonded on the vestibular surfaces of the upper right premolars (1.4 and 1.5) and the upper right first molar (1.6). A composite resin is polymerized on the top of the buttons. Then, participants are divided into two groups.

  • Trial Group: participants from this group will receive a manual toothbrush and Biorepair Total Protection toothpaste for home oral hygiene after lunches.
  • Control Groups: participants from this group will receive a manual toothbrush and Sensodyne Repair & Protect for home oral hygiene after lunches.

After 7 days from the procedure of bonding, the buttons on upper right first premolars (1.4) are debonded. After 15 days from the procedure of bonding, the buttons on upper right second premolars (1.5) are debonded. In the end, After 30 days from the procedure of bonding, the buttons on upper right first molars (1.6) are debonded.

Debonded buttons are then stored in sterile environment at 2-3°C temperature; successively, they are sent to laboratory for SEM evaluation.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients
  • No current orthodontic treatment during the study
  • No use of occlusal splint or retention device

Exclusion Criteria:

  • Presence of white spot lesions on the vestibular surfaces of teeth
  • Corrupted vestibular surfaces of teeth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trial Group
Volunteers from this group will have bonded buttons on vestibular surfaces of elements 1.4, 1.5 and 1.6. Then they will use Biorepair Total Protection for home oral care for 30 days. In this time period, the buttons will be respectively debonded at 7 (1.4), 15 (1.5) and 30 (1.6) days after the bonding procedures, in order to be evaluated at SEM.
Other: Biorepair Total Protection
Volunteers will use Biorepair Total Protection for home oral hygiene for the following 30 days from the bonding procedure.
Active Comparator: Control Group
Volunteers from this group will have bonded buttons on vestibular surfaces of elements 1.4, 1.5 and 1.6. Then they will use Sensodyne Repair & Protect for home oral care for 30 days. In this time period, the buttons will be respectively debonded at 7 (1.4), 15 (1.5) and 30 (1.6) days after the bonding procedures, in order to be evaluated at SEM.
Other: Sensodyne Repair & Protect
Volunteers will use Sensodyne Repair & Protect for home oral hygiene for the following 30 days from the bonding procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% microRepair® on composite surfaces
Time Frame: 7 days from the bonding procedure.
SEM evaluation of the percentage of microRepair® on composite surfaces.
7 days from the bonding procedure.
% microRepair® on composite surfaces
Time Frame: 15 days from the bonding procedure.
SEM evaluation of the percentage of microRepair® on composite surfaces.
15 days from the bonding procedure.
% microRepair® on composite surfaces
Time Frame: 30 days from the bonding procedure.
SEM evaluation of the percentage of microRepair® on composite surfaces.
30 days from the bonding procedure.
Comparison with Control Group
Time Frame: 7 days from the bonding procedure.
SEM evaluation of the possibile differences between Trial and Control Groups.
7 days from the bonding procedure.
Comparison with Control Group
Time Frame: 15 days from the bonding procedure.
SEM evaluation of the possibile differences between Trial and Control Groups.
15 days from the bonding procedure.
Comparison with Control Group
Time Frame: 30 days from the bonding procedure.
SEM evaluation of the possibile differences between Trial and Control Groups.
30 days from the bonding procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2021

Primary Completion (Actual)

May 5, 2021

Study Completion (Actual)

May 10, 2021

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-BUTTONS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon motivated request to Principal Investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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