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

Sponsor

University of Pavia (Other)

Overall Status

Completed

CT.gov ID

NCT04808557

Collaborator

(none)

Enrollment

Location

Arms

1.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries Dental Fillings	Other: Biorepair Total Protection Other: Sensodyne Repair & Protect	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Mar 24, 2021

Actual Primary Completion Date :

May 5, 2021

Actual Study Completion Date :

May 10, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

% microRepair® on composite surfaces [7 days from the bonding procedure.]
SEM evaluation of the percentage of microRepair® on composite surfaces.
% microRepair® on composite surfaces [15 days from the bonding procedure.]
SEM evaluation of the percentage of microRepair® on composite surfaces.
% microRepair® on composite surfaces [30 days from the bonding procedure.]
SEM evaluation of the percentage of microRepair® on composite surfaces.
Comparison with Control Group [7 days from the bonding procedure.]
SEM evaluation of the possibile differences between Trial and Control Groups.
Comparison with Control Group [15 days from the bonding procedure.]
SEM evaluation of the possibile differences between Trial and Control Groups.
Comparison with Control Group [30 days from the bonding procedure.]
SEM evaluation of the possibile differences between Trial and Control Groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy	Italy	27100

Sponsors and Collaborators

University of Pavia

Investigators

Principal Investigator: Andrea Scribante, DDS, PhD., University of Pavia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrea Scribante, Research Resident, Principal Investigator, University of Pavia

ClinicalTrials.gov Identifier:

NCT04808557

Other Study ID Numbers:

2021-BUTTONS

First Posted:

Mar 22, 2021

Last Update Posted:

May 11, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Andrea Scribante, Research Resident, Principal Investigator, University of Pavia

Composite resins

Toothpastes

Orthodontic buttons

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of May 11, 2021