search
Back to results

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
Dr. Joachim Enax
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts 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

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

First Posted
May 17, 2019
Last Updated
January 29, 2020
Sponsor
Dr. Joachim Enax
search

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

We'll reach out to this number within 24 hrs