Status:
COMPLETED
Testing if Tartarase Can Remove Dental Tartar
Lead Sponsor:
Pontis Biologics, Inc.
Collaborating Sponsors:
Salus Research, Inc., 1220 Medical Park Dr. A, Fort Wayne ID 46825
Reinhard Schuller Consulting, 37 Poplar Heights Dr., Toronto, Ontario M9A 5A1
Conditions:
Dental Calculus
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study was designed to find our whether a novel toothpaste containing safe digestive enzymes (Tartarase) was able to remove pre-existing dental tartar when compared to a well-known toothpaste (Cre...
Detailed Description
Quality assurance All raw data (Case Report Forms) were screened for quality assurance by the Investigators' Quality Assurance officer (QA) and found to be in compliance with protocol requirements bef...
Eligibility Criteria
Inclusion
- In order to be included in the study, each subject must have:
- Provided written informed consent to participate in the study;
- Adult subjects aged 18 years and older, that were in good health;
- Agreed not to participate in any other oral/dental product studies during the course of this study and used only the assigned oral hygiene products during the entire study (including toothbrushes, toothpastes, home remedies, floss or other products like chewing gum, mouthwashes, tongue cleaners, etc.);
- Agreed to refrain from the use of any elective dentistry (including a non-study dental prophylaxis) until the study had been completed;
- Agreed to refrain from the use of any non-study oral hygiene and whitening products;
- Been in good general health, as determined by the investigator/designee based on a review of the health history/update for participation in the study;
- Had six mandibular anterior teeth with no crowns or veneers;
- Agreed to comply with the study procedures and schedule, including the follow up visits;
- Had at least 9mm of dental calculus on the mandibular anterior six teeth and reported that they had received a dental cleaning in previous 2-6 months.
- Healthy Volunteers
Exclusion
- Had a medical condition requiring antibiotic premedication prior to dental procedures;
- Regularly used chlorhexidine mouth rinse;
- Had any oral condition or pathosis that could interfere with study compliance and/or examination procedures (e.g., widespread caries, chronic neglect, advanced periodontal disease);
- Had current or history of oral cavity cancer or oropharyngeal cancer;
- Were pregnant or nursing by subject report;
- Did not brush regularly;
- Had any condition that might have made it unsafe for the subject to participate in this study, at the discretion of the investigator.
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT06139835
Start Date
June 8 2022
End Date
July 6 2022
Last Update
November 18 2023
Active Locations (1)
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1
Pontis Biologics, Inc
Huntington, New York, United States, 11743