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

NCT ID: NCT04808557

Last Updated: 2021-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-24

Study Completion Date

2021-05-10

Brief Summary

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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

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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.

Conditions

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Dental Caries Dental Fillings

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Biorepair Total Protection

Intervention Type OTHER

Volunteers will use Biorepair Total Protection for home oral hygiene for the following 30 days from the bonding procedure.

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.

Group Type ACTIVE_COMPARATOR

Sensodyne Repair & Protect

Intervention Type OTHER

Volunteers will use Sensodyne Repair \& Protect for home oral hygiene for the following 30 days from the bonding procedure.

Interventions

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Biorepair Total Protection

Volunteers will use Biorepair Total Protection for home oral hygiene for the following 30 days from the bonding procedure.

Intervention Type OTHER

Sensodyne Repair & Protect

Volunteers will use Sensodyne Repair \& Protect for home oral hygiene for the following 30 days from the bonding procedure.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Research Resident, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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2021-BUTTONS

Identifier Type: -

Identifier Source: org_study_id

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