Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287424
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2021-03-09
Brief Title:
The Efficacy Of AGE On Periodontitis
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
An Exploratory Eighteen Month Clinical Study To Evaluate Efficacy Of AGE Product On Periodontitis A Dose Response Study
Status:
COMPLETED
Status Verified Date:
2021-03
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 objective of this study is to assess the long-term efficacy of AGE among on deep periodontal pockets by different doses of AGE for a period of 18 months
Detailed Description:
This is a randomized controlled examiner-blind 4-treatment parallel group study The study will be conducted at the Hebrew University Hadassah Israel A sufficient number of subjects will be screened to obtain approximately 300 generally healthy adult volunteers with moderate to deep periodontal pockets
Subjects will be stratified and randomly assigned equally to either one from the 3 regimen groups with different doses of AGE or a control group Placebo
Subjects will be requested to use the products at home for the duration of the study according to the written and verbal usage instructions given to them during product distribution At Baseline Month 6 Month 12 and Month 18 subjects will receive oral soft tissue exams and will have periodontal measurements made as described in below
All groups will receive supra-gingival dental prophylaxes every 6 month consistent with local norms and standards Products will be re-supplied approximately every six months following Baseline During study conduct subjects with evidence of progressive periodontal disease 3 mm increases in pocket depth attachment loss or recession will be exited from the study and treated following local norms
Subjects will be stratified and randomly assigned equally to either one from the 3 regimen groups with different doses of AGE or a control group Placebo
Subjects will be requested to use the products at home for the duration of the study according to the written and verbal usage instructions given to them during product distribution At Baseline Month 6 Month 12 and Month 18 subjects will receive oral soft tissue exams and will have periodontal measurements made as described in below
All groups will receive supra-gingival dental prophylaxes every 6 month consistent with local norms and standards Products will be re-supplied approximately every six months following Baseline During study conduct subjects with evidence of progressive periodontal disease 3 mm increases in pocket depth attachment loss or recession will be exited from the study and treated following local norms
Study Oversight
Has Oversight DMC:
None
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?:
None