Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults

NCT04756557 | Completed

• 1 other identifier: PoznanUMS
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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 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

Keywords

tooth demineralization; cariostatic agent; protective agent; toothpaste

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects showing no increase in overall DMFS-index

  Proportion of subjects showing no increase in overall DMFS-index (DMFSVisit 4 - DMFSVisit 1 = 0) during the observation period

  546 days

Secondary Outcomes (2)

• roportion of subjects experiencing no change in mineral density

  546 days

• Changes in the coverage of all teeth with bacterial plaque ac-cording to the criteria of the Plaque Control Record

  546 days

Study Arms (2)

Tooth Brushing HAP Toothpaste

EXPERIMENTAL

Experimental: Tooth Brushing HAP HAP-Toothpaste Tooth Brushing HAP Prophylactic cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated toothpaste containing microcrystalline hydroxylapatite two x daily over the duration of the study (18 months). Procedure: Tooth Brushing HAP

Other: Experimental.

Tooth Brushing F Toothpaste

ACTIVE COMPARATOR

Cleaning teeth using a standardized electric tooth brush and a fluoridated tooth paste containing amino fluoride (1450 ppm F-), (two x daily over the duration of the study (18 months).

Other: Active comparator

Interventions

Experimental. OTHER

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.

Also known as: Karex Toothpaste with 10% Hydroxyapatite

Tooth Brushing HAP Toothpaste

Active comparator OTHER

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.

Also known as: Karex Base with sodium fluoride 1450 F-

Tooth Brushing F Toothpaste

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead
• Medical University of Bialystok: collaborator
• Dr. Kurt Wolff GmbH & Co. KG: collaborator

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 60-812, Poland

Location

Related Publications (9)

• Walsh T, Worthington HV, Glenny AM, Marinho VC, Jeroncic A. Fluoride toothpastes of different concentrations for preventing dental caries. Cochrane Database Syst Rev. 2019 Mar 4;3(3):CD007868. doi: 10.1002/14651858.CD007868.pub3.

  PMID: 30829399 BACKGROUND

• Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.

  PMID: 23268518 RESULT

• Paszynska E, Pawinska M, Gawriolek M, Kaminska I, Otulakowska-Skrzynska J, Marczuk-Kolada G, Rzatowski S, Sokolowska K, Olszewska A, Schlagenhauf U, May TW, Amaechi BT, Luczaj-Cepowicz E. Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial. Sci Rep. 2021 Jan 29;11(1):2650. doi: 10.1038/s41598-021-81112-y.

  PMID: 33514787 RESULT

• Amaechi BT, AbdulAzees PA, Alshareif DO, Shehata MA, Lima PPCS, Abdollahi A, Kalkhorani PS, Evans V. Comparative efficacy of a hydroxyapatite and a fluoride toothpaste for prevention and remineralization of dental caries in children. BDJ Open. 2019 Dec 9;5:18. doi: 10.1038/s41405-019-0026-8. eCollection 2019.

  PMID: 31839988 RESULT

• Hummel R, Akveld NAE, Bruers JJM, van der Sanden WJM, Su N, van der Heijden GJMG. Caries Progression Rates Revisited: A Systematic Review. J Dent Res. 2019 Jul;98(7):746-754. doi: 10.1177/0022034519847953. Epub 2019 May 9.

  PMID: 31070943 RESULT

• O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.

  PMID: 4500182 RESULT

• Poulsen VJ. Caries risk children in the Danish child dental service. Scand J Prim Health Care. 1987 Sep;5(3):169-75. doi: 10.3109/02813438709013999.

  PMID: 3671918 RESULT

• Tschoppe P, Zandim DL, Martus P, Kielbassa AM. Enamel and dentine remineralization by nano-hydroxyapatite toothpastes. J Dent. 2011 Jun;39(6):430-7. doi: 10.1016/j.jdent.2011.03.008. Epub 2011 Apr 8.

  PMID: 21504777 RESULT

• Paszynska E, Pawinska M, Enax J, Meyer F, Schulze Zur Wiesche E, May TW, Amaechi BT, Limeback H, Hernik A, Otulakowska-Skrzynska J, Krahel A, Kaminska I, Lapinska-Antonczuk J, Stokowska E, Gawriolek M. Caries-preventing effect of a hydroxyapatite-toothpaste in adults: a 18-month double-blinded randomized clinical trial. Front Public Health. 2023 Jul 18;11:1199728. doi: 10.3389/fpubh.2023.1199728. eCollection 2023.

  PMID: 37533523 DERIVED

MeSH Terms

Conditions

Dental Caries; Tooth Demineralization

Interventions

Durapatite

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydroxyapatites; Apatites; Calcium Phosphates; Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Calcium Compounds; Minerals; Phosphorus Compounds

Study Officials

• Elzbieta Paszynska, Prof

  Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The study will be double-blinded (blinded for the study subjects as well as for the investigators). The blind must not be broken throughout the study. Only after study end, study subjects will be informed on the toothpaste received, if requested by the subject.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Integrated Dentistry, Principal Investigator, Clinical Associate Professor

Model Details: Multicenter, double-blind, randomized, active-controlled parallel-group study.

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: January 9, 2023
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)