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Hydroxyapatite-toothpaste and Enamel Caries in the Primary Dentition (ECIPDEN17)

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ClinicalTrials.gov Identifier: NCT03553966
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
Medical University of Bialystok
Wuerzburg University Hospital
Poznan University of Medical Sciences
Information provided by (Responsible Party):
Elzbieta Paszynska, Dr. Kurt Wolff GmbH & Co. KG

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


Condition or disease Intervention/treatment Phase
Tooth Decay Hydroxyapatite Tooth Demineralization Tooth Diseases Procedure: Prophylactic Procedure: Cleaning teeth Device: Restorative dentistry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, double-blind, randomized, active-controlled parallel-group study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of the Daily Use of Hydroxyapatite-toothpaste on the Occurrence of Enamel Caries in the Primary Dentition (ECIPDEN17)
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Durapatite

Arm Intervention/treatment
Experimental: Tooth Brushing HAP+Restorative dentistry

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: Prophylactic
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.
Other Name: ECIPDEN17

Device: Restorative dentistry
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.

Active Comparator: Tooth Brushing F+Restorative dentistry

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 teeth
Tooth Brushing F 3x daily repeated cleaning of all teeth using a standardized electric tooth brush and a fluoridated tooth paste.
Other Name: ECIPDEN17

Device: Restorative dentistry
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.




Primary Outcome Measures :
  1. Percentage of study subjects experiencing new enamel caries lesions (≥ ICDAS code 1) [ Time Frame: 336 days ]

    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.



Secondary Outcome Measures :
  1. Gingival Inflammation using the Gingival Index [ Time Frame: 336 days ]
    Changes in the status of gingival health in the gingiva of the assessed primary molars according to the criteria of the Modified Gingival Index..

  2. Plaque Coverage using the Plaque Control Record [ Time Frame: 336 days ]
    Changes in the coverage of the assessed primary molars with bacterial plaque according to the criteria of the Plaque Control Record.

  3. Percentage of study subjects experiencing new enamel caries lesions (≥ ICDAS code 2) [ Time Frame: 336 day ]
    Percentage of study subjects experiencing the new development of at least one enamel caries lesions ≥ ICDAS code 2 during the observation period (336 days).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553966


Contacts
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Contact: Elzbieta Paszynska, Assoc. Prof. +48601551189 paszynska@ump.edu.pl
Contact: Malgorzata Pawinska, Assoc. Prof. +48693245095 malgosiapaw@interia.pl

Locations
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Poland
Poznan University of Medical Sciences, Department of Integrated Dentistry Recruiting
Poznan, Poland
Contact: Elzbieta Paszynska, Assoc.Prof.    +48601551189    paszynska@ump.edu.pl   
Contact: Malgorzata Pawinska, Assoc.Prof.    +48693245095    malgosiapaw@interia.pl   
Sub-Investigator: Maria Gawriolek, PhD         
Sub-Investigator: Justyna Otulakowska-Skrzynska, PhD         
Sub-Investigator: Szymon Rzatowski, PhD         
Sub-Investigator: Inga Kaminska, PhD         
Sub-Investigator: Grazyna Marczuk-Kolada, PhD         
Sub-Investigator: Elzbieta Luczaj-Cepowicz, PhD         
Sub-Investigator: Katarzyna Sokołowska, PhD         
Sub-Investigator: Aneta Olszewska, PhD         
Sponsors and Collaborators
Dr. Kurt Wolff GmbH & Co. KG
Medical University of Bialystok
Wuerzburg University Hospital
Poznan University of Medical Sciences
Investigators
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Principal Investigator: Elzbieta Paszynska, Assoc. Prof. Poznan University of Medical Sciences

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

Other Publications:
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Responsible Party: Elzbieta Paszynska, DDS, PhD, Assoc. Prof.,, Dr. Kurt Wolff GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT03553966    
Other Study ID Numbers: Dr. Kurt Wolff Group
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: we do not plan any individual participant data available data to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elzbieta Paszynska, Dr. Kurt Wolff GmbH & Co. KG:
Dental caries
Toothpaste
Fluoride
Hydroxyapatite
Additional relevant MeSH terms:
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Tooth Diseases
Tooth Demineralization
Calcium Metabolism Disorders
Stomatognathic Diseases
Metabolic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs