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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Dental Caries, Dental Fillings

Intervention / Treatment
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* Other: Biorepair Total Protection
* Other: Sensodyne Repair & Protect


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trial Group<br>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<br>* Volunteers will use Biorepair Total Protection for home oral hygiene for the following 30 days from the bonding procedure.<br>|
| Active Comparator: Control Group<br>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<br>* Volunteers will use Sensodyne Repair & Protect for home oral hygiene for the following 30 days from the bonding procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Composite resins, Toothpastes, Orthodontic buttons