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Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque

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ClinicalTrials.gov Identifier: NCT03956992
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Joachim Enax, Dr. Kurt Wolff GmbH & Co. KG

Brief Summary:
The aim of this pilot study is to analyze if a hydroxyapatite-containing mouth gel has an influence on the calcium content of plaque.

Condition or disease Intervention/treatment Phase
Dental Caries Other: Mouth gel Not Applicable

Detailed Description:

>= 20 subjects (7-11 years) use the hydroxyapatite-containing mouth gel for 3 days (3x per day); without using any other oral care product at this time. A dentist applies the gel on all teeth. At baseline and after 3 days plaque will be collected from buccal and labial surfaces (except surfaces with tartar). A "split-mouth" concept will be used:

Subjects in group A:

Baseline plaque collection: quadrant 1 and 4 Plaque collection after 3 days: quadrant 2 and 3

Subjects in group B:

Baseline plaque collection: quadrant 2 and 3 Plaque collection after 3 days: quadrant 1 and 4 (The time between last application of the gel and plaque collection will be 1 h) The plaque will be dried and afterwards the calcium content of the plaque will be quantitively analyzed by atomic absorption spectroscopy (AAS).

For all subjects: Calcium contents of plaque at baseline and after 3 days application will be compared by statistical methods.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
Estimated Study Start Date : August 8, 2019
Estimated Primary Completion Date : August 10, 2019
Estimated Study Completion Date : August 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: Mouth gel
A mouth gel with hydroxyapatite
Other: Mouth gel
Stop using the mouth gel




Primary Outcome Measures :
  1. Calcium content of plaque [ Time Frame: 3 days ]
    Analysis by atomic absorption spectroscopy (AAS)



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Girls and boys (7-11 years)
  • Visible plaque
  • >= 4 teeth
  • Good overall health

Exclusion Criteria:

  • Allergic to one or more ingredients of the mouth gel
  • Medication intake (e.g. antibiotics)
  • 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): NCT03956992


Contacts
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Contact: Henny Sudradjat +49 531 4707239 henny.sudradjat@braunschweig.de
Contact: Joachim Enax, Dr. +49 521 8808-6064 joachim.enax@drwolffgroup.com

Locations
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Indonesia
Health department Recruiting
Bali, Kebon Padangan, Indonesia
Contact: Henny Sudradjat    +49 531 4707239    henny.sudradjat@braunschweig.de   
Sponsors and Collaborators
Dr. Joachim Enax
Investigators
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Principal Investigator: Henny Sudradjat Department for Dentistry, Health Care Center, Braunschweig, Germany

Publications:
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Responsible Party: Dr. Joachim Enax, Senior Scientist Oral Care, Dr. Kurt Wolff GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT03956992     History of Changes
Other Study ID Numbers: Dr. Kurt Wolff
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs