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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-08

Study Completion Date

2019-08-10

Brief Summary

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

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Detailed Description

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\>= 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.

Conditions

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Dental Caries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mouth gel

A mouth gel with hydroxyapatite

Group Type EXPERIMENTAL

Mouth gel

Intervention Type OTHER

Stop using the mouth gel

Interventions

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Mouth gel

Stop using the mouth gel

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes