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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Other: Mouth gel

• Registration Number: NCT03956992
• Lead Sponsor: Dr. Joachim Enax

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.

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 Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-21
• Study Start: 2019-08-08
• Primary Completion: 2019-08-10
• Study Completion: 2019-08-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mouth gel	Mouth gel	A mouth gel with hydroxyapatite

Primary Outcome Measures

Name	Time	Method
Calcium content of plaque	3 days	Analysis by atomic absorption spectroscopy (AAS)

Trial Locations

Locations (1)

Health department; 🇮🇩 Bali, Kebon Padangan, Indonesia