Status:
COMPLETED
Open-label Trial Evaluating Four Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste, and Mouthwash
Lead Sponsor:
Biokosmes Srl
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Oral Hygiene
Toothbrushing
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this open-label, randomized controlled clinical trial, is to provide preliminary clinical data (efficacy on plaque and gingival sensitivity, and safety and tolerability of two types of ...
Detailed Description
A complete line of cosmetic products (Tau-marin Protezione e Prevenzione) was launched on the Italian market in 2023. These products are based on an innovative formulation containing a prebiotic (Bioe...
Eligibility Criteria
Inclusion
- Healthy Caucasian males and females aged ≥ 18 to ≤ 65 years included.
- Proper oral hygiene not performed verified with Simplified Oral Hygiene Index (OHI-S) (score ≥ 2) and a questionnaire on oral habit.
- Patients able to comply with the requirements for the study and freely willing to provide written informed consent to the collection of their data.
- Registered with Italian National Health Service (NHS).
- Ability to understand the language used in the investigation center and to comply with the study procedures.
- Unbanned pharmacological therapy stable for at least one month without any changes during the study.
- Commitment not to change the daily routine and lifestyle.
Exclusion
- Allergies or sensitivity to oral care products, cosmetic products, drugs, patch or medical devices.
- Any oral cavity condition inappropriate for participation.
- Gums bleeding due to pathologies/pharmacological treatment.
- Concomitant or during the last week antibiotic therapy.
- Smokers (≥5 cigarettes/day).
- Acute, chronic or progressive diseases/illness/conditions able to interfere with the outcome of the study or considered dangerous or incompatible with the study requirements.
- Pathological staining of teeth.
- Breast-feeding, pregnancy, or women of child-bearing age unwilling to take the necessary precautions to avoid pregnancy during the study.
- Planning to participate or participation in other clinical trials withing 30 days.
- Hospitalization/planned hospitalization in a health or social facility.
- Deprivation of freedom by administrative or legal decision or under guardianship
- Inability to be contacted in case of emergency.
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2022
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05999175
Start Date
May 17 2022
End Date
September 9 2022
Last Update
May 22 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Studio D. Cattaneo
San Genesio ed Uniti, Pavia, Italy, 27010
2
Complife Italia Srl
San Martino Siccomario, Pavia, Italy, 27028