Effect of Herbal Extracts on Gingival Inflammation

NCT00554034 | Completed Phase 2

• 1 other identifier: Protocol C-4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Keywords

gingivitis, localized treatment

Outcome Measures

Primary Outcomes (1)

• To determine the correct dosing of the herbal Patch [THPP]

  3 months

Secondary Outcomes (1)

• To demonstarte the safety of THPP on the gingival tissue and in the oral cavity

  3 months

Interventions

periopatch DRUG

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 Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 -75.
• Severe localized gingival inflammation \[GI index 2 or greater

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Jerusalem Perio Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Menachem Oberbaum, M.D.

  Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: November 6, 2007
• Study Start: November 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 21, 2010

Record last verified: 2009-04

Locations

IL (1)