NCT04808557

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries
• Dental Fillings

Interventions

Type	Name	Description
OTHER	Biorepair Total Protection	Volunteers will use Biorepair Total Protection for home oral hygiene for the following 30 days from the bonding procedure.
OTHER	Sensodyne Repair & Protect	Volunteers will use Sensodyne Repair \& Protect for home oral hygiene for the following 30 days from the bonding procedure.

Timeline

• Start date: 2021-03-24
• Primary completion: 2021-05-05
• Completion: 2021-05-10
• First posted: 2021-03-22
• Last updated: 2021-05-11

Locations

1 site across 1 country: Italy