Effect of Herbal Extracts on Gingival Inflammation

Gingivitis Clinical Trial

Official title:

The Effect of Herbal Extracts on Inflammatory Enzymes in the Gingiva: a Dose Finding Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554034
• Other study ID #: Protocol C-4
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2007
• Last updated: December 19, 2010
• Start date: November 2007
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the minimal number of patches needed to get an effective response. Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study. After the first 20 patients [5 cycles], the effect of the number of patches will be tested. If there is no distinct reduction of beta glucuronidase in the GCF or of gingival index at the tested sites, more patients will be enrolled. Patients will be added one cycle at a time with results being tested and analyzed. The enrollemnts of patients will stop when a dose response will be noticed or 15 cycles have been reached.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18 -75.

2. Severe localized gingival inflammation [GI index 2 or greater

Exclusion Criteria:

1. Pregnancy or a wish to become pregnant during the study.

2. History of periodontal treatment within the last month.

3. Antibiotic treatment within the last month

4. Use of any antimicrobial mouthrinse within the last month.

5. Participation in another trial one month prior to the study.

6. Inability to behave compliant to the trial protocol by not placing all the patches given, or attending scheduled appointments.

7. Systemic Disease.

8. Patients using salicylate

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• periopatch
Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study.

Locations

Country	Name	City	State
Israel	Jerusalem Perio Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the correct dosing of the herbal Patch [THPP]		3 months	No
Secondary	To demonstarte the safety of THPP on the gingival tissue and in the oral cavity		3 months	No