Herbal Periodontal Patch (THPP) for Gingival Inflammation... | NCT00731432

Studies
Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

NCT00731432

Sponsor

Izun Pharma Ltd

Status

Suspended

Last Update Posted

Jul 20, 2011Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Gingival Inflammation in Diabetic Patients

Interventions

Transmucosal Herbal Periodontal Patch (THPP)
Placebo Patch

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

Aug 2008

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Failure to recruit

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 7, 2008

First Submission Date that Met QC Criteria

Aug 8, 2008

First Posted Date

Aug 11, 2008Estimated

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

Jul 19, 2011

Last Update Posted Date

Jul 20, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Diabetes increases the incidence and severity of periodontal inflammation and disease, and periodontal disease causes an increase in the severity of diabetes by worsening glycemic control and increasing insulin resistance.The Transmucosal Herbal Periodontal Patch (THPP) is a transmucosal patch containing an herbal compound that has an anti-inflammatory effect on gingival tissue.The primary objective of this study is to determine the efficacy of the Transmucosal Herbal Periodontal Patch (THPP) compared with placebo patch (PP) in reducing gingival inflammation at the site of placement in diabetic patients. We also aim to determine if the THPP decreases gingival inflammation throughout the mouth and the safety of THPP compared with placebo patch when applied to the mucosa in the treatment of gingival inflammation in diabetic patients.

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

Label	Type	Description	Intervention Names
A	Experimental	Transmucosal Herbal Periodontal Patch (THPP)	Drug: Transmucosal Herbal Periodontal Patch (THPP)
B	Placebo Comparator	Placebo Patch	Drug: Placebo Patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transmucosal Herbal Periodontal Patch (THPP)	Drug	Patch applied to oral gingiva	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint of the study will be the comparison between THPP and PP in reducing the gingival index (GI) at the site of patch placement		5 days

Secondary Outcomes

Measure	Description	Time Frame
frequency and severity of any adverse event		5 days
Beta-glucuronidase enzyme found in gingival crevicular fluid (GCF) of the tested sites. The GCF will be collected from the second most posterior tooth in all four quadrants.		5 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female patients between the ages of 18 and 85 years
Patients must have a minimum of 3 posterior teeth in all quadrants
A mean gingival index (GI) of >1.5 on the posterior teeth
Diagnosis of Diabetes type 1 or 2, adequately controlled by diet and/or medications, as determined by the patient's physician

Exclusion Criteria:

Allergy to any herbal medications
Pregnancy or lactation
Periodontal treatment in the last three months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 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
Oded Yaniv, DMD	Izun Pharma Limited	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herzog Hospital		Jerusalem		91035	Israel

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis
D003920	Diabetes Mellitus

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided