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Completed

NCT Number: NCT04808557

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

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.

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Key information

Conditions

Dental Caries Dental Fillings Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biorepair Total Protection

Other

Volunteers will use Biorepair Total Protection for home oral hygiene for the following 30 days from the bonding procedure.

Sensodyne Repair & Protect

Other

Volunteers will use Sensodyne Repair & Protect for home oral hygiene for the following 30 days from the bonding procedure.

Primary outcomes

  1. % microRepair® on composite surfaces

    Time frame: 7 days from the bonding procedure.

    SEM evaluation of the percentage of microRepair® on composite surfaces.

  2. % microRepair® on composite surfaces

    Time frame: 15 days from the bonding procedure.

    SEM evaluation of the percentage of microRepair® on composite surfaces.

  3. % microRepair® on composite surfaces

    Time frame: 30 days from the bonding procedure.

    SEM evaluation of the percentage of microRepair® on composite surfaces.

  4. Comparison with Control Group

    Time frame: 7 days from the bonding procedure.

    SEM evaluation of the possibile differences between Trial and Control Groups.

  5. Comparison with Control Group

    Time frame: 15 days from the bonding procedure.

    SEM evaluation of the possibile differences between Trial and Control Groups.

  6. Comparison with Control Group

    Time frame: 30 days from the bonding procedure.

    SEM evaluation of the possibile differences between Trial and Control Groups.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2021
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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