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Completed

NCT Number: NCT00554034

Effect of Herbal Extracts on Gingival Inflammation

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jerusalem Perio Center

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. To determine the correct dosing of the herbal Patch [THPP]

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 6, 2007
Registry last updated
Dec 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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