NCT03956992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 8, 2019

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2019

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

2 days

First QC Date

May 17, 2019

Last Update Submit

January 29, 2020

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Calcium content of plaque

    Analysis by atomic absorption spectroscopy (AAS)

    3 days

Study Arms (1)

Mouth gel

EXPERIMENTAL

A mouth gel with hydroxyapatite

Other: Mouth gel

Interventions

Mouth gelOTHER

Stop using the mouth gel

Mouth gel

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Girls and boys (7-11 years)
  • Visible plaque
  • \>= 4 teeth
  • Good overall health

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health department

Bali, Kebon Padangan, Indonesia

Location

Related 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. doi: 10.1159/000260715. No abstract available.

    PMID: 6580080BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Henny Sudradjat

    Department for Dentistry, Health Care Center, Braunschweig, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Scientist Oral Care

Study Record Dates

First Submitted

May 17, 2019

First Posted

May 21, 2019

Study Start

August 8, 2019

Primary Completion

August 10, 2019

Study Completion

August 10, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)