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Hydroxyapatite-toothpaste and Enamel Caries in the Primary Dentition

NCT03553966 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-02-06

No results posted yet for this study

Summary

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

Conditions

  • Tooth Decay
  • Hydroxyapatite
  • Tooth Demineralization
  • Tooth Diseases

Interventions

PROCEDURE

Prophylactic

Tooth Brushing HA 3x daily repeated cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated tooth paste containing microcrystalline hydroxylapatite.

PROCEDURE

Cleaning teeth

Tooth Brushing F 3x daily repeated cleaning of all teeth using a standardized electric tooth brush and a fluoridated tooth paste.

DEVICE

Restorative dentistry

If in a subject a significant increase of carious lesions will be observed, her/his parents are informed about the necessity for further caries preventive measures (e.g. dietary changes, use of fluoride products, reduction of cariogenic microflora with chlorhexidine, xylitol chewing gum, etc.) and caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.

Sponsors & Collaborators

  • Medical University of Bialystok

    collaborator OTHER

  • Wuerzburg University Hospital

    collaborator OTHER

  • Poznan University of Medical Sciences

    collaborator OTHER

  • Dr. Kurt Wolff GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Elzbieta Paszynska, Assoc. Prof. · Poznan University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Poland

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 NCT03553966 on ClinicalTrials.gov