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

Dental Caries 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04808557
• Other study ID #: 2021-BUTTONS
• Status: Completed
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: May 10, 2021

Study information

• Verified date: May 2021
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 10, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Fillings

Intervention

Other:
• Biorepair Total Protection
Volunteers will use Biorepair Total Protection for home oral hygiene for the following 30 days from the bonding procedure.
• Sensodyne Repair & Protect
Volunteers will use Sensodyne Repair & Protect for home oral hygiene for the following 30 days from the bonding procedure.

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% microRepair® on composite surfaces	SEM evaluation of the percentage of microRepair® on composite surfaces.	7 days from the bonding procedure.
Primary	% microRepair® on composite surfaces	SEM evaluation of the percentage of microRepair® on composite surfaces.	15 days from the bonding procedure.
Primary	% microRepair® on composite surfaces	SEM evaluation of the percentage of microRepair® on composite surfaces.	30 days from the bonding procedure.
Primary	Comparison with Control Group	SEM evaluation of the possibile differences between Trial and Control Groups.	7 days from the bonding procedure.
Primary	Comparison with Control Group	SEM evaluation of the possibile differences between Trial and Control Groups.	15 days from the bonding procedure.
Primary	Comparison with Control Group	SEM evaluation of the possibile differences between Trial and Control Groups.	30 days from the bonding procedure.