Back to resultsEffect of Herbal Extracts on Gingival Inflammation
Primary Purpose
Gingivitis
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
periopatch
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis focused on measuring gingivitis, localized treatment
Eligibility Criteria
Inclusion Criteria:
- Age 18 -75.
- Severe localized gingival inflammation [GI index 2 or greater
Exclusion Criteria:
- Pregnancy or a wish to become pregnant during the study.
- History of periodontal treatment within the last month.
- Antibiotic treatment within the last month
- Use of any antimicrobial mouthrinse within the last month.
- Participation in another trial one month prior to the study.
- Inability to behave compliant to the trial protocol by not placing all the patches given, or attending scheduled appointments.
- Systemic Disease.
- Patients using salicylate
Sites / Locations
- Jerusalem Perio Center
Outcomes
Primary Outcome Measures
To determine the correct dosing of the herbal Patch [THPP]
Secondary Outcome Measures
To demonstarte the safety of THPP on the gingival tissue and in the oral cavity
Full Information
NCT ID
NCT00554034
First Posted
October 15, 2007
Last Updated
December 19, 2010
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00554034
Brief Title
Effect of Herbal Extracts on Gingival Inflammation
Official Title
The Effect of Herbal Extracts on Inflammatory Enzymes in the Gingiva: a Dose Finding Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
gingivitis, localized treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
periopatch
Intervention Description
Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study.
Primary Outcome Measure Information:
Title
To determine the correct dosing of the herbal Patch [THPP]
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To demonstarte the safety of THPP on the gingival tissue and in the oral cavity
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 -75.
Severe localized gingival inflammation [GI index 2 or greater
Exclusion Criteria:
Pregnancy or a wish to become pregnant during the study.
History of periodontal treatment within the last month.
Antibiotic treatment within the last month
Use of any antimicrobial mouthrinse within the last month.
Participation in another trial one month prior to the study.
Inability to behave compliant to the trial protocol by not placing all the patches given, or attending scheduled appointments.
Systemic Disease.
Patients using salicylate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menachem Oberbaum, M.D.
Organizational Affiliation
Shaare Zedek Medical Center, Jerusalem, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jerusalem Perio Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
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Effect of Herbal Extracts on Gingival Inflammation
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