Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-02-12 @ 6:05 PM
Study NCT ID:
NCT04808557
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2021-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SEM Evaluation of the Quantity of microRepair® on Resin Composite Surfaces: an in Vivo Randomized Clinical Trial.
Sponsor:
University of Pavia
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: