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

Primary Purpose

Dental Caries, Dental Fillings

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Biorepair Total Protection
Sensodyne Repair & Protect
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Composite resins, Toothpastes, Orthodontic buttons

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Trial Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

% microRepair® on composite surfaces
SEM evaluation of the percentage of microRepair® on composite surfaces.
% microRepair® on composite surfaces
SEM evaluation of the percentage of microRepair® on composite surfaces.
% microRepair® on composite surfaces
SEM evaluation of the percentage of microRepair® on composite surfaces.
Comparison with Control Group
SEM evaluation of the possibile differences between Trial and Control Groups.
Comparison with Control Group
SEM evaluation of the possibile differences between Trial and Control Groups.
Comparison with Control Group
SEM evaluation of the possibile differences between Trial and Control Groups.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2021
Last Updated
May 10, 2021
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT04808557
Brief Title
SEM Evaluation of the Quantity of microRepair® on Resin Composite Surfaces: an in Vivo Randomized Clinical Trial.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
May 5, 2021 (Actual)
Study Completion Date
May 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Dental Fillings
Keywords
Composite resins, Toothpastes, Orthodontic buttons

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Volunteers will have buttons bonded on the vestibular surfaces of elements 1.4,1.5,1.6. Then, they will be randomly divided into two groups: Trial Group will use Biorepair Total Protection toothpaste for home oral care, whereas Control Group will use Sensodyne Repair & Protect for home oral care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trial Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Biorepair Total Protection
Intervention Description
Volunteers will use Biorepair Total Protection for home oral hygiene for the following 30 days from the bonding procedure.
Intervention Type
Other
Intervention Name(s)
Sensodyne Repair & Protect
Intervention Description
Volunteers will use Sensodyne Repair & Protect for home oral hygiene for the following 30 days from the bonding procedure.
Primary Outcome Measure Information:
Title
% microRepair® on composite surfaces
Description
SEM evaluation of the percentage of microRepair® on composite surfaces.
Time Frame
7 days from the bonding procedure.
Title
% microRepair® on composite surfaces
Description
SEM evaluation of the percentage of microRepair® on composite surfaces.
Time Frame
15 days from the bonding procedure.
Title
% microRepair® on composite surfaces
Description
SEM evaluation of the percentage of microRepair® on composite surfaces.
Time Frame
30 days from the bonding procedure.
Title
Comparison with Control Group
Description
SEM evaluation of the possibile differences between Trial and Control Groups.
Time Frame
7 days from the bonding procedure.
Title
Comparison with Control Group
Description
SEM evaluation of the possibile differences between Trial and Control Groups.
Time Frame
15 days from the bonding procedure.
Title
Comparison with Control Group
Description
SEM evaluation of the possibile differences between Trial and Control Groups.
Time Frame
30 days from the bonding procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Scribante, DDS, PhD.
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
City
Pavia
State/Province
Lombardy
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon motivated request to Principal Investigator

Learn more about this trial

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

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