Effect of Herbal Extracts on Gingival Inflammation | NCT00554034

Studies
Effect of Herbal Extracts on Gingival Inflammation

NCT00554034

Sponsor

Shaare Zedek Medical Center

Status

Completed

Last Update Posted

Dec 21, 2010Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Gingivitis

Interventions

periopatch

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Oct 15, 2007

First Submission Date that Met QC Criteria

Nov 5, 2007

First Posted Date

Nov 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2010

Last Update Posted Date

Dec 21, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the correct dosing of the herbal Patch [THPP]		3 months

Secondary Outcomes

Measure	Description	Time Frame
To demonstarte the safety of THPP on the gingival tissue and in the oral cavity		3 months

Other Outcomes

Not provided

Eligibility Module

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](streamdown:incomplete-link)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Menachem Oberbaum, M.D.	Shaare Zedek Medical Center, Jerusalem, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jerusalem Perio Center		Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis

Ancestor Terms

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided