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

D

Dr. Joachim Enax

Status

Completed

Conditions

Dental Caries

Treatments

Other: Mouth gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT03956992
Dr. Kurt Wolff

Details and patient eligibility

About

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

Full 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.

Enrollment

34 patients

Sex

All

Ages

7 to 11 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

Mouth gel
Experimental group
Description:
A mouth gel with hydroxyapatite
Treatment:
Other: Mouth gel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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