Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics

The Effect Of A Transmucosal Herbal Periodontal Patch (THPP) on Gingival Inflammation in Diabetic Patients

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00731432

Enrollment

Registered

2008-08-11

Start date

2008-08-31

Completion date

Unknown

Last updated

2011-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Inflammation in Diabetic Patients

Keywords

gingivitis, diabetes mellitus, herbal, oral inflammation

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.

Interventions

DRUGTransmucosal Herbal Periodontal Patch (THPP)

Patch applied to oral gingiva

DRUGPlacebo Patch

Identical in shape and texture to treatment patch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026