Actively Recruiting
Caries-preventing Effect of 2% Calcium Hypophosphite Toothpaste Compared to a Sodium Fluoride Toothpaste (1450ppm F) in Adults
Led by Dr. Joachim Enax · Updated on 2026-04-13
164
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
D
Dr. Joachim Enax
Lead Sponsor
D
Department of Integrated Dentistry Medical University of Białystok
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing the caries-preventive effects of two toothpastes in adults aged 18 to 45. The study aims to show that a toothpaste containing 2% Calcium Hypophosphite is not worse than a standard Sodium Fluoride toothpaste (1450 ppm fluoride) in preventing dental caries. The trial is sponsored by Dr. Joachim Enax and involves healthy volunteers. Participants will be randomly assigned to use either the 2% Calcium Hypophosphite toothpaste or the Sodium Fluoride toothpaste. Both groups will receive oral hygiene instructions and will apply their assigned toothpaste twice daily at home for 18 months (546 days). This is a quadruple-masked study to ensure unbiased results. During the study, participants will have evaluations including oral examinations by intraoral camera (DIAGNOcam), bitewing radiographs, and assessments of dental plaque using the Plaque Control Record index. The main outcome measured is the Decay-Missing-Filled index at multiple time points up to 546 days. Secondary outcomes include prevention of interproximal caries lesions and dental plaque accumulation. Participants will be monitored throughout the 18-month period.
CONDITIONS
Brief Title
Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fluoride Toothpaste (1450ppm F)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 45 years
- At least 10 healthy molars and premolars without decay or fillings (DMFS = 0)
- Willing to use an electric (powered) toothbrush
- Willing to use interdental floss
- Willing to have bitewing radiographs taken
- Willing to undergo oral examination by intraoral camera (DIAGNOcam)
You will not qualify if you...
- Untreated caries requiring restoration (three or more untreated caries lead to exclusion)
- Xerostomia caused by medication, radiation, or disease
- Undergoing chemotherapy or radiation therapy
- Physical or mental disability preventing proper oral health care
- Currently receiving orthodontic treatment
- Severe periodontitis at baseline (pocket depth ≥ 5.5 mm on at least one tooth)
- Known allergy to ingredients of the tested toothpastes
- Taking medications that affect saliva production or flow
- Current pregnancy, breastfeeding, or planning pregnancy during the study
- Three or more carious lesions or restorations in the last 36 months before baseline
- Teeth lost due to caries in the last 36 months before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 18 months
Participants apply their assigned toothpaste (2% Calcium Hypophosphite Toothpaste or Sodium Fluoride Toothpaste) twice daily at home while following oral hygiene instructions.
Visits on Day 1, Day 182±28, Day 365±28, and Day 546±28 for assessments
Trial Site Locations
Total: 2 locations
1
Department of Integrated Dentistry Medical University of Białystok
Bialystok, Poland, Poland, 15-276
Not Yet Recruiting
2
Poznan University of Medical Sciences, Department of Integrated Dentistry
Poznan, Poland, Poland, 60-812
Actively Recruiting
Research Team
J
Joachim Enax, PhD
C
Clarissa Masur, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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