Effect of Herbal Extracts on Gingival Inflammation

This study has been completed.
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00554034
First received: October 15, 2007
Last updated: December 19, 2010
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Gingivitis
Drug: periopatch
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Herbal Extracts on Inflammatory Enzymes in the Gingiva: a Dose Finding Study.

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • To determine the correct dosing of the herbal Patch [THPP] [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To demonstarte the safety of THPP on the gingival tissue and in the oral cavity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554034

Locations
Israel
Jerusalem Perio Center
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Menachem Oberbaum, M.D. Shaare Zedek Medical Center, Jerusalem, Israel
  More Information

No publications provided

Responsible Party: Menachem Oberbaum, MD, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00554034     History of Changes
Other Study ID Numbers: Protocol C-4
Study First Received: October 15, 2007
Last Updated: December 19, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
gingivitis, localized treatment

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 22, 2014