NCT04808557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

March 24, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

1 month

First QC Date

March 16, 2021

Last Update Submit

May 10, 2021

Conditions

Dental CariesDental Fillings

Keywords

Composite resinsToothpastesOrthodontic buttons

Outcome Measures

Primary Outcomes (6)

  • % microRepair® on composite surfaces

    SEM evaluation of the percentage of microRepair® on composite surfaces.

    7 days from the bonding procedure.

  • % microRepair® on composite surfaces

    SEM evaluation of the percentage of microRepair® on composite surfaces.

    15 days from the bonding procedure.

  • % microRepair® on composite surfaces

    SEM evaluation of the percentage of microRepair® on composite surfaces.

    30 days from the bonding procedure.

  • Comparison with Control Group

    SEM evaluation of the possibile differences between Trial and Control Groups.

    7 days from the bonding procedure.

  • Comparison with Control Group

    SEM evaluation of the possibile differences between Trial and Control Groups.

    15 days from the bonding procedure.

  • Comparison with Control Group

    SEM evaluation of the possibile differences between Trial and Control Groups.

    30 days from the bonding procedure.

Study Arms (2)

Trial Group

ACTIVE COMPARATOR

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Biorepair Total ProtectionOTHER

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

Trial Group
Sensodyne Repair & ProtectOTHER

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

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Andrea Scribante, DDS, PhD.

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Resident, Principal Investigator

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 22, 2021

Study Start

March 24, 2021

Primary Completion

May 5, 2021

Study Completion

May 10, 2021

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Data will be available upon motivated request to Principal Investigator

Locations

IT(1)