Dental Caries Clinical Trial
— CA1Official title:
Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults
Verified date | January 2023 |
Source | Poznan University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 192 |
Est. completion date | January 9, 2023 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Poznan University of Medical Sciences | Poznan |
Lead Sponsor | Collaborator |
---|---|
Poznan University of Medical Sciences | Dr. Kurt Wolff GmbH & Co. KG, Medical University of Bialystok |
Poland,
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; — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | roportion of subjects experiencing no change in mineral density | A) Proportion of subjects experiencing no change in mineral density (as analyzed by DIAGNOcam) during the observation period of time | 546 days | |
Secondary | Changes in the coverage of all teeth with bacterial plaque ac-cording to the criteria of the Plaque Control Record | B) Changes in the coverage of all teeth with bacterial plaque ac-cording to the criteria of the Plaque Control Record (PCR; O'Leary et al. 1972) | 546 days |
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