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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03956992
Enrollment
34
Registered
2019-05-21
Start date
2019-08-08
Completion date
2019-08-10
Last updated
2020-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

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.

Interventions

OTHERMouth gel

Stop using the mouth gel

Sponsors

Dr. Joachim Enax
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Calcium content of plaque3 daysAnalysis by atomic absorption spectroscopy (AAS)

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026