Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults

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 permanent dentition compared to the regular use of a fluoride control toothpaste (1450 ppm F-) with proven caries preventive efficacy (Walsh et al. 2019)? This multicenter, non-inferiority clinical trial, randomized, double-blind, active-controlled design, two-armed study evaluates the hypothesis that the home regular use of a toothpaste containing microcrystalline hydroxylapatite (HAP) (test toothpaste) provides a caries preventive effect in adults aged 18-45 comparable to the caries preventive effect provided by the regular use of a fluoridated tooth paste (1450 ppm -F) (control toothpaste) over observation periods of max. 18 months. Caries development will be assessed according to the clinical criteria of the Decay Missing Filling Surface Index (DMFS).

Conditions

• Dental Caries
• Hydroxyapatite
• Tooth Decay
• Dentin, Carious
• Enamel Caries

Interventions

OTHER

Experimental.

Tooth Brushing HAP 2x daily repeated cleaning of all teeth 3 min. using a standardized electric tooth brush Electric (powered) toothbrushes (Oral-B; P\&G, Schwalbach, Germany), brushing head: medium; will be changed every 2 months and a non-fluoridated tooth paste containing microcrystalline hydroxyapatite . HAP-toothpaste (Karex toothpaste with 10 % hydroxyapatite) If a subject shows multiple carious lesions during the course of the study, the study dentist will decide whether the subject must be excluded from the study. In this case the subject will receive additional intensive caries prophylactic measures (e.g. chlorhexi-dine gel application, dietary counselling, etc.). Caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.

OTHER

Active comparator

Tooth Brushing F 2x daily repeated cleaning of all teeth 3min.using a standardized electric tooth brush ((Oral-B; P\&G, Schwalbach, Germany) and a fluoridated toothpaste (Karex Base with sodium fluoride 1450 F-), brushing head: medium; will be changed every 2 months If a subject shows multiple carious lesions during the course of the study, the study dentist will decide whether the subject must be excluded from the study. In this case the subject will receive additional intensive caries prophylactic measures (e.g. chlorhexidine gel application, dietary counselling, etc.). Caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.

Sponsors & Collaborators

• Medical University of Bialystok

  collaborator OTHER

• Dr. Kurt Wolff GmbH & Co. KG

  collaborator INDUSTRY

• Poznan University of Medical Sciences

  lead OTHER

Principal Investigators

• Elzbieta Paszynska, Prof · Poznan University of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2021-06-30

Completion

2023-01-09

Countries

• Poland

Study Locations