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NCT03956992 Clinical Trial

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

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03956992
Other study ID # Dr. Kurt Wolff
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2019
Est. completion date August 10, 2019

Study information
Verified date January 2020
Source Dr. Kurt Wolff GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date August 10, 2019
Est. primary completion date August 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 11 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Mouth gel
Stop using the mouth gel

Locations
Country Name City State
Indonesia Health department Bali Kebon Padangan

Sponsors (1)
Lead Sponsor Collaborator
Dr. Joachim Enax

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Calcium content of plaque Analysis by atomic absorption spectroscopy (AAS) 3 days
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