Testing if Tartarase Can Remove Dental Tartar

NCT06139835 | Completed

• 1 other identifier: PB2022-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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 (Crest). A group of 40 test subjects that had at lease 9 mm of tartar on the tongue side of the 6 lower front teeth, were randomly divided into 3 groups unknown to the the team overseeing the measurements. All the groups brushed with a toothbrush approved by the American Dental Association. Group A (20 subject) was the control group. They brushed in the morning and before bed with Crest for 2 minutes. Group B (10 subjects) brushed in the morning and before bed using the same procedure, first with Tartarase for 30 seconds, spit, but did not rinse, then repeated. After 30 minutes then brushed with Crest. Group C (10 subjects) brushed for 30 seconds with Tartarase, spit but did not rinse, then filled a dental tray with Tartarase and covered the 6 lower front teeth and waited 30 minutes, spit but did not rinse and brushed for ann additional 30 seconds with Tartarase. After 30 minutes they brushed with Crest. They brushed with crest before bed, without another Tartarase treatment. The study was a 4-week study, with tartar measured at the start (baseline), again after 2 weeks and again at the final study point of 4 weeks. If any of the study subjects experienced anything unpleasant, they were to inform the team overseeing the study. The tartar measurements were compiled into the 3 groups and statistically analyzed to determine if there were any changes in the amount of tartar within the groups and between the groups.

Conditions

Dental Calculus

Keywords

gingivitis; dentifrice; plaque

Outcome Measures

Primary Outcomes (1)

• Tartarase Efficacy

  Assess the change in calculus abundance measured by the V-MI in groups brushing with Crest, the Tartarase brushing group and the Tartarase tray group.

  4 weeks

Study Arms (3)

Control

ACTIVE COMPARATOR

Individuals randomly assigned to the control arm where they brushed their teeth with a popular toothpaste (crest) in the morning and before bed. This routine was repeated daily for 4 weeks.

Biological: Tartarase

Tartarase brushing

EXPERIMENTAL

In the morning, this group brushed with Tartarase for 30 seconds, spit, but did not rinse and repeated the process. In 30 minutes they brushed with Crest. They repeated this routine before bed. This routine was repeated daily for 4 weeks.

Biological: Tartarase

Tartarase tray

EXPERIMENTAL

In the morning this group brushed with Tartarase for 30 seconds, filled a dental tray with Tartarase and applied it to the 6 lower front teeth and left it for 30 minutes, spit but did not rinse then brushed with Tartarase for another 30 seconds, spit, but did not rinse. In 30 minutes they brushed with Crest. Before bed they brushed with Crest alone. This routine was repeated daily for 4 weeks.

Biological: Tartarase

Interventions

Tartarase BIOLOGICAL

Brushing with a formulation containing DNase 1 and chymotrypsin to assess its efficacy at removing accumulated calculus

Control; Tartarase brushing; Tartarase tray

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontis Biologics, Inc.: lead
• Salus Research, Inc., 1220 Medical Park Dr. A, Fort Wayne ID 46825: collaborator
• Reinhard Schuller Consulting, 37 Poplar Heights Dr., Toronto, Ontario M9A 5A1: collaborator

Study Sites (1)

Pontis Biologics, Inc

Huntington, New York, 11743, United States

Location

Related Publications (2)

• VOLPE AR, MANHOLD JH, HAZEN SP. IN VIVO CALCULUS ASSESSMENT. I. A METHOD AND ITS EXAMINER REPRODUCIBILITY. J Periodontol (1930). 1965 Jul-Aug;36:292-8. doi: 10.1902/jop.1965.36.4.292. No abstract available.

  PMID: 14326695 RESULT

• Milleman KR, Deener G, Milleman JL, Mish B, Schuller R, Mynarcik D. A proof of principle investigation of a novel enzyme formulation on dental calculus deposition: a 4-week randomized human clinical trial. BMC Oral Health. 2024 Jun 22;24(1):720. doi: 10.1186/s12903-024-04498-x.

  PMID: 38909189 DERIVED

MeSH Terms

Conditions

Dental Calculus; Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Dennis C. Mynarcik, PhD

  Pontis Biologics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The group of study subjects, selected from the study site's database were randomized by the statistician into three different treatment groups. The personnel performing the measurements were blinded as to which group the study subjects we in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparison of the change in calculus abundance of two treatment groups, using the same dentifrice with two different methods of application with a control group using a popular standard dentifrice.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: June 8, 2022
• Primary Completion: July 6, 2022
• Study Completion: July 6, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)