Effect of Herbal Extracts on Gingival Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gingivitis

Keywords

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gingivitis, localized treatment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Shaare Zedek Medical Center

Principal Investigators

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Menachem Oberbaum, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center, Jerusalem, Israel

Locations

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Jerusalem Perio Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Protocol C-4

Identifier Type: -

Identifier Source: org_study_id