Sponsor study identifier
interventional
20
1 country
1
Study Start
March 24, 2021
Actual (reported)Primary Completion
May 5, 2021
Actual (reported)Study Completion
May 10, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 10, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 16, 2021
Actual (reported)March 22, 2021
Actual (reported)March 24, 2021
Actual (reported)May 5, 2021
Actual (reported)May 10, 2021
Actual (reported)% 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.
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.
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.
Volunteers will use Biorepair Total Protection for home oral hygiene for the following 30 days from the bonding procedure.
Volunteers will use Sensodyne Repair \& Protect for home oral hygiene for the following 30 days from the bonding procedure.
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100, Italy
Andrea Scribante, DDS, PhD.
University of Pavia
20 participants (actual enrollment reported by the registry).
First Submitted
March 16, 2021
First Posted
March 22, 2021
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
March 24, 2021
Actual (reported)Primary Completion
May 5, 2021
Actual (reported)Study Completion
May 10, 2021
Actual (reported)Last Updated
May 11, 2021
Record last verified: 2021-05
Data will be available upon motivated request to Principal Investigator
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Source: ClinicalTrials.gov.
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