NCT03553966

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

April 23, 2018

Last Update Submit

February 5, 2020

Conditions

Tooth DecayHydroxyapatiteTooth DemineralizationTooth Diseases

Keywords

Dental cariesToothpasteFluorideHydroxyapatite

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Gingival Inflammation using the Gingival Index

    336 days

  • Plaque Coverage using the Plaque Control Record

    336 days

  • Percentage of study subjects experiencing new enamel caries lesions (≥ ICDAS code 2)

    336 day

Study Arms (2)

Tooth Brushing HAP+Restorative dentistry

EXPERIMENTAL

Arm Intervention: HA-Toothpaste Tooth Brushing HA Prophylactic cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated toothpaste containing microcrystalline hydroxylapatite 3x daily over the duration of the study (336 days). Procedure: Tooth Brushing HA

Procedure: ProphylacticDevice: Restorative dentistry

Tooth Brushing F+Restorative dentistry

ACTIVE COMPARATOR

Cleaning teeth using a standardized electric tooth brush and a fluoridated tooth paste containing amino fluoride (500 ppm F-), (three times daily over the duration of the study (336 days). Intervention: Procedure: Tooth Brushing F 3x daily repeated cleaning of all teeth using a standardized electric tooth brush and a fluoridated toothpaste.

Procedure: Cleaning teethDevice: Restorative dentistry

Interventions

ProphylacticPROCEDURE

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.

Also known as: ECIPDEN17
Tooth Brushing HAP+Restorative dentistry
Cleaning teethPROCEDURE

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

Also known as: ECIPDEN17
Tooth Brushing F+Restorative dentistry
Restorative dentistryDEVICE

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.

Tooth Brushing F+Restorative dentistryTooth Brushing HAP+Restorative dentistry

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences, Department of Integrated Dentistry

Poznan, Poland

Location

Related Publications (16)

  • 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. No abstract available.

    PMID: 3485495BACKGROUND

  • 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: 4500182BACKGROUND

  • 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: 23268518BACKGROUND

  • 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.

    PMID: 20091655BACKGROUND

  • REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products. (2009).

    BACKGROUND

  • 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.

    PMID: 28364672BACKGROUND

  • 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.

    PMID: 29559639RESULT

  • 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. doi: 10.1111/j.1600-0528.2007.00347.x.

    PMID: 17518963RESULT

  • 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. doi: 10.1111/eje.12131. Epub 2014 Dec 12.

    PMID: 25495379RESULT

  • Loe H. Mechanical and chemical control of dental plaque. J Clin Periodontol. 1979 Dec;6(7):32-6. doi: 10.1111/j.1600-051x.1979.tb02116.x. No abstract available.

    PMID: 295293RESULT

  • 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 384-5. doi: 10.1038/sj.bdj.2008.582.

    PMID: 18849940RESULT

  • World Medical Association: Declaration of Helsinki. Recommendations guiding medical physi-cians in biomedical research involving human subjects, 59th WMA General Assembly, Seoul, October, 2008

    RESULT

  • 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 Dig Health Legis. 1997;48(2):231-4. No abstract available.

    PMID: 11656783RESULT

  • 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 Health. A Randomized Trial. PLoS One. 2016 Jul 28;11(7):e0160142. doi: 10.1371/journal.pone.0160142. eCollection 2016.

    PMID: 27467683RESULT

  • 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 5;5:333. doi: 10.3389/fphys.2014.00333. eCollection 2014.

    PMID: 25249980RESULT

  • 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: 33514787DERIVED

MeSH Terms

Conditions

Dental CariesTooth DemineralizationTooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

  • Elzbieta Paszynska, Assoc. 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)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Multicenter, double-blind, randomized, active-controlled parallel-group study.
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, PhD, Assoc. Prof.,

Study Record Dates

First Submitted

April 23, 2018

First Posted

June 12, 2018

Study Start

March 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

we do not plan any individual participant data available data to other researchers

Locations

PL(1)