Tooth Diseases Clinical Trial
— ECIPDEN17Official title:
Impact of the Daily Use of Hydroxyapatite-toothpaste on the Occurrence of Enamel Caries in the Primary Dentition (ECIPDEN17)
Verified date | February 2020 |
Source | Dr. Kurt Wolff GmbH & Co. KG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 200 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility |
Inclusion Criteria: - age 3-6 years - complete set of fully erupted primary molars (teeth 55, 54, 64, 65, 75, 74, 84, 85) - presence of a caries restoration (filling) on a minimum of 1 primary molar - minimum of 4 primary molars without a restoration or fissure sealing Exclusion Criteria: - untreated caries lesions of ICDAS code 3-6 - known hypersensitivity to one of the ingredients of the toothpastes to be tested - systemic disorders interfering with salivary function or flow - regular medication intake interfering with salivary function or flow - need for antibiotic prophylaxis during dental treatments - 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, disqualifies the subject from participating in the study |
Country | Name | City | State |
---|---|---|---|
Poland | Poznan University of Medical Sciences, Department of Integrated Dentistry | Poznan |
Lead Sponsor | Collaborator |
---|---|
Dr. Kurt Wolff GmbH & Co. KG | Medical University of Bialystok, Poznan University of Medical Sciences, Wuerzburg University Hospital |
Poland,
Harks I, Jockel-Schneider Y, Schlagenhauf U, May TW, Gravemeier M, Prior K, Petersilka G, Ehmke B. Impact of the Daily Use of a Microcrystal Hydroxyapatite Dentifrice on De Novo Plaque Formation and Clinical/Microbiological Parameters of Periodontal Healt — View Citation
Hiller KA, Buchalla W, Grillmeier I, Neubauer C, Schmalz G. In vitro effects of hydroxyapatite containing toothpastes on dentin permeability after multiple applications and ageing. Sci Rep. 2018 Mar 20;8(1):4888. doi: 10.1038/s41598-018-22764-1. — View Citation
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) adopts Consolidated Guideline on Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use. Int — View Citation
Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. — View Citation
Kensche A, Holder C, Basche S, Tahan N, Hannig C, Hannig M. Efficacy of a mouthrinse based on hydroxyapatite to reduce initial bacterial colonisation in situ. Arch Oral Biol. 2017 Aug;80:18-26. doi: 10.1016/j.archoralbio.2017.03.013. Epub 2017 Mar 23. — View Citation
Lelli M, Putignano A, Marchetti M, Foltran I, Mangani F, Procaccini M, Roveri N, Orsini G. Remineralization and repair of enamel surface by biomimetic Zn-carbonate hydroxyapatite containing toothpaste: a comparative in vivo study. Front Physiol. 2014 Sep — View Citation
Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. — View Citation
Löe H. Mechanical and chemical control of dental plaque. J Clin Periodontol. 1979 Dec;6(7):32-6. — View Citation
Luz PB, Stringhini CH, Otto BR, Port AL, Zaleski V, Oliveira RS, Pereira JT, Lussi A, Rodrigues JA. Performance of undergraduate dental students on ICDAS clinical caries detection after different learning strategies. Eur J Dent Educ. 2015 Nov;19(4):235-41 — View Citation
Milsom KM, Blinkhorn AS, Tickle M. The incidence of dental caries in the primary molar teeth of young children receiving National Health Service funded dental care in practices in the North West of England. Br Dent J. 2008 Oct 11;205(7):E14; discussion 38 — View Citation
O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. — 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
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products. (2009).
Walsh T, Worthington HV, Glenny AM, Appelbe P, Marinho VC, Shi X. Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007868. doi: 10.1002/14651858.CD007868.pub2. Review. Update in: Cochrane Database Syst Rev. 2019 Mar 04;3:CD007868. — View Citation
World Medical Association: Declaration of Helsinki. Recommendations guiding medical physi-cians in biomedical research involving human subjects, 59th WMA General Assembly, Seoul, October, 2008
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of study subjects experiencing new enamel caries lesions (= ICDAS code 1) | Percentage of study subjects experiencing the new development of at least one enamel caries lesions = ICDAS code 1 or the progression of an existing enamel caries lesion by at least one ICDAS code on any of the evaluated primary molars during the observation period of 336 days. Reference: ICDAS II code (International Caries Detection and Assessment System; ICDAS); Ismail et al. 2007. |
336 days | |
Secondary | Gingival Inflammation using the Gingival Index | Changes in the status of gingival health in the gingiva of the assessed primary molars according to the criteria of the Modified Gingival Index.. | 336 days | |
Secondary | Plaque Coverage using the Plaque Control Record | Changes in the coverage of the assessed primary molars with bacterial plaque according to the criteria of the Plaque Control Record. | 336 days | |
Secondary | Percentage of study subjects experiencing new enamel caries lesions (= ICDAS code 2) | Percentage of study subjects experiencing the new development of at least one enamel caries lesions = ICDAS code 2 during the observation period (336 days). | 336 day |
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