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NCT03553966: ECIPDEN17
Hydroxyapatite-toothpaste and Enamel Caries in the Primary Dentition
NA trial testing Prophylactic in Tooth Decay in 200 participants. Completed in 31 December 2019.
31 December 2019
Quick facts
| Lead sponsor | Dr. Kurt Wolff GmbH & Co. KG |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 200 |
| Start date | 1 March 2018 |
| Primary completion | 31 December 2019 |
| Estimated completion | 31 December 2019 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Prophylactic — full drug profile →
- Cleaning teeth
- Restorative dentistry
Conditions studied
- Tooth Decay — all drugs for Tooth Decay →
- Hydroxyapatite — all drugs for Hydroxyapatite →
- Tooth Demineralization — all drugs for Tooth Demineralization →
- Tooth Diseases — all drugs for Tooth Diseases →
Sponsor
Dr. Kurt Wolff GmbH & Co. KG
Who can join
Adults 3 to 6, any sex, with Tooth Decay or Hydroxyapatite. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This multicenter, non-inferiority trial randomized, double-blind, active controlled parallel group study evaluates the hypothesis that the home regular use of a toothpaste containing microcrystalline hydroxylapatite (HAP) (test toothpaste) provides a caries preventive effect in caries-active children with primary dentition age 3-6 which is comparable to the caries preventive effect provided by the regular use of a fluoridated tooth paste (F) (control toothpaste) over observation periods of max. 336 days. Caries development will be assessed according to the clinical criteria of the International Caries Detection and Assessment System (ICDAS). Condition or disease: Intervention Procedure: Tooth Brushing HAP or Procedure: Tooth Brushing F
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial.
Paszynska E, Pawinska M, Gawriolek M, Kaminska I, et al · · 2021 · cited 41× · PMID 33514787 · DOI 10.1038/s41598-021-81112-y
Verify or expand the search:
- PubMed search for NCT03553966
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Tooth Decay
Currently open trials in the same condition.
- NCT06286501 — Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03553966 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. Kurt Wolff GmbH & Co. KG
- Last refreshed: 6 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03553966.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing