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

January 29, 2020 updated by: Dr. Joachim Enax
The aim of this pilot study is to analyze if a hydroxyapatite-containing mouth gel has an influence on the calcium content of plaque.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Kebon Padangan
      • Bali, Kebon Padangan, Indonesia
        • Health department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mouth gel
A mouth gel with hydroxyapatite
Other: Mouth gel
Stop using the mouth gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calcium content of plaque
Time Frame: 3 days
Analysis by atomic absorption spectroscopy (AAS)
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Joachim Enax

Investigators

  • Principal Investigator: Henny Sudradjat, Department for Dentistry, Health Care Center, Braunschweig, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2019

Primary Completion (Actual)

August 10, 2019

Study Completion (Actual)

August 10, 2019

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dr. Kurt Wolff

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe