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Testing if Tartarase Can Remove Dental Tartar

NCT06139835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

BIOLOGICAL

Tartarase

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

Sponsors & Collaborators

  • Salus Research, Inc., 1220 Medical Park Dr. A, Fort Wayne ID 46825

    collaborator UNKNOWN

  • Reinhard Schuller Consulting, 37 Poplar Heights Dr., Toronto, Ontario M9A 5A1

    collaborator UNKNOWN

  • Pontis Biologics, Inc.

    lead INDUSTRY

Principal Investigators

  • Dennis C. Mynarcik, PhD · Pontis Biologics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2022-07-06
Completion
2022-07-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06139835 on ClinicalTrials.gov