Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
Study NCT ID:
NCT03956992
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2019-05-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
Sponsor:
Dr. Joachim Enax
Organization:
Study Overview
Official Title:
Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: