Clinical trial NCT04808557: SEM Evaluation of the Quantity of microRepair® on Resin Composite Surfaces: an in Vivo Randomized 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Dental Fillings
Keywords: Composite resins
Toothpastes
Orthodontic buttons
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: % microRepair® on composite surfaces
timeFrame: 7 days from the bonding procedure.
measure: % microRepair® on composite surfaces
timeFrame: 15 days from the bonding procedure.
measure: % microRepair® on composite surfaces
timeFrame: 30 days from the bonding procedure.
measure: Comparison with Control Group
timeFrame: 7 days from the bonding procedure.
measure: Comparison with Control Group
timeFrame: 15 days from the bonding procedure.
measure: Comparison with Control Group
timeFrame: 30 days from the bonding procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD.
role: PRINCIPAL_INVESTIGATOR
References: