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

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: Dental Caries
• Intervention / Treatment: Other: Mouth gel

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Analysis by atomic absorption spectroscopy (AAS)	3 days

Collaborators and Investigators

• Sponsor: Dr. Joachim Enax
• Investigators: Principal Investigator: Henny Sudradjat, Department for Dentistry, Health Care Center, Braunschweig, Germany

Publications and helpful links

General Publications

• Shaw L, Murray JJ, Burchell CK, Best JS. Calcium and phosphorus content of plaque and saliva in relation to dental caries. Caries Res. 1983;17(6):543-8. doi: 10.1159/000260715. No abstract available.

Study record dates

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: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• 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