NCT06139835

Testing if Tartarase Can Remove Dental Tartar

Completed NA Last updated 18 November 2023

What this trial tests

NA trial testing Tartarase in Dental Calculus in 37 participants. Completed in 6 July 2022.

Timeline

8 June 2022

Primary endpoint
6 July 2022

6 July 2022

Quick facts

Lead sponsor	Pontis Biologics, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	37
Start date	8 June 2022
Primary completion	6 July 2022
Estimated completion	6 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Tartarase — full drug profile →

Conditions studied

• Dental Calculus — all drugs for Dental Calculus →

Sponsor

Pontis Biologics, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Dental Calculus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A proof of principle investigation of a novel enzyme formulation on dental calculus deposition: a 4-week randomized human clinical trial.
   Milleman KR, Deener G, Milleman JL, Mish B, et al · · 2024 · PMID 38909189 · DOI 10.1186/s12903-024-04498-x