Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Mouth gel
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
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
Sites / Locations
- Health department
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mouth gel
Arm Description
A mouth gel with hydroxyapatite
Outcomes
Primary Outcome Measures
Calcium content of plaque
Analysis by atomic absorption spectroscopy (AAS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03956992
Brief Title
Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
Official Title
Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
August 10, 2019 (Actual)
Study Completion Date
August 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Joachim Enax
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mouth gel
Arm Type
Experimental
Arm Description
A mouth gel with hydroxyapatite
Intervention Type
Other
Intervention Name(s)
Mouth gel
Intervention Description
Stop using the mouth gel
Primary Outcome Measure Information:
Title
Calcium content of plaque
Description
Analysis by atomic absorption spectroscopy (AAS)
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henny Sudradjat
Organizational Affiliation
Department for Dentistry, Health Care Center, Braunschweig, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health department
City
Bali
State/Province
Kebon Padangan
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
6580080
Citation
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. doi: 10.1159/000260715. No abstract available.
Results Reference
background
Learn more about this trial
Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
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