Status:
COMPLETED
Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults
Lead Sponsor:
Poznan University of Medical Sciences
Collaborating Sponsors:
Medical University of Bialystok
Dr. Kurt Wolff GmbH & Co. KG
Conditions:
Dental Caries
Hydroxyapatite
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Target question is as the following one: Does the daily use of a fluoride-free, microcrystalline hydroxyap-atite (HAP) - containing test toothpaste have a non-inferior caries preventing effect in the...
Detailed Description
Caries-preventing effects of hydroxyapatite toothpastes have been shown in vivo \[children and adolescents\] (Schlagenhauf et al. 2019, Paszynska et al. 2021), in situ (Amaechi et al. 2019), and in vi...
Eligibility Criteria
Inclusion
- provision of written informed consent
- age 18-45 years (both men and women)
- a minimum of 10 healthy molars and premolars (DMFS of these teeth = 0)
- willing to use an electric (powered) toothbrush
Exclusion
- Medical Reasons
- untreated caries \[clinical investigation and analysis with DI-AGNOcam\] (→ unsuitable subjects with untreated caries in need of a restoration can become eligible after restorative therapy)
- severe periodontitis at the baseline-visit (pocket depth on at least one tooth ≥ 5.5 mm)
- orthodontic treatment
- known hypersensitivity to one of the ingredients of the tooth-pastes to be tested
- systemic disorders interfering with salivary function or flow
- regular medication intake interfering with salivary function or flow
- Other Reasons:
- Participation in any other clinical study within the past 3 months or ongoing
- lack of intellectual or physical ability to conduct the study properly
- Any other reason that, in the opinion of the investigator, dis-qualifies the subject from participating in the study
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2023
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT04756557
Start Date
January 1 2021
End Date
January 9 2023
Last Update
January 10 2023
Active Locations (1)
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1
Poznan University of Medical Sciences
Poznan, Poland, 60-812