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OpenTrials
Completed

NCT Number: NCT03956992

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.

Completed

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health department

Bali, Kebon Padangan, Indonesia

About this study

>= 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mouth gel

Other

Stop using the mouth gel

Primary outcomes

  1. Calcium content of plaque

    Time frame: 3 days

    Analysis by atomic absorption spectroscopy (AAS)

Sponsors and collaborators

Lead sponsor

Dr. Joachim Enax

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 21, 2019
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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