Gingival Inflammation in Diabetic PatientsPhase 2NCT00731432
Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics
A Phase 2 study testing Transmucosal Herbal Periodontal Patch (THPP) in people with Gingival Inflammation in Diabetic Patients, run by Izun Pharma Ltd at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gingival Inflammation in Diabetic Patients
- What is being tested?
- Transmucosal Herbal Periodontal Patch (THPP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergy to any herbal medications
- Pregnancy or lactation
- Periodontal treatment in the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of A Transmucosal Herbal Periodontal Patch (THPP) on Gingival Inflammation in Diabetic Patients
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.
- Being tested
- Transmucosal Herbal Periodontal Patch (THPP), Placebo Patch
- Keywords
- gingivitis, diabetes mellitus, herbal, oral inflammation
- Medical subject headings
- Gingivitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transmucosal Herbal Periodontal Patch (THPP)Drug
Also called Day 1: 1 patch X 3/d, Day 2-3: 1 patch X1/d, Days 4-5: no patch
Patch applied to oral gingiva
Placebo PatchDrug
Also called Day 1: 1 patch X 3/d, Day 2-3: 1 patch X1/d, Days 4-5: no patch
Identical in shape and texture to treatment patch
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Transmucosal Herbal Periodontal Patch (THPP) Receives: Drug: Transmucosal Herbal Periodontal Patch (THPP) |
| B | Placebo comparator | Placebo Patch Receives: Drug: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 days
Secondary outcomes (2)
frequency and severity of any adverse event
Measured: 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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startAug 2008
Why it stopped: Failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Inflammation in Diabetic PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izun Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Oded Yaniv, DMD, Principal investigator, Izun Pharma Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731432
- Sponsor's protocol ID
- C-3
- Status last verified
- Aug 2008
- First submitted
- 7 Aug 2008
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of A Transmucosal Herbal Periodontal Patch (THPP) on Gingival Inflammation in Diabetic Patients
- ClinicalTrials.gov ID
- NCT00731432
- Acronym / sponsor ID
- C-3
- Keywords
- gingivitis, diabetes mellitus, herbal, oral inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Failure to recruit
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Izun Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Transmucosal Herbal Periodontal Patch (THPP)Transmucosal Herbal Periodontal Patch (THPP) |
| B | Placebo comparator | Drug: Placebo PatchPlacebo Patch |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Allergy to any herbal medications
- Pregnancy or lactation
- Periodontal treatment in the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transmucosal Herbal Periodontal Patch (THPP)Also: Day 1: 1 patch X 3/d, Day 2-3: 1 patch X1/d, Days 4-5: no patchPatch applied to oral gingiva | Drug | A |
| Placebo PatchAlso: Day 1: 1 patch X 3/d, Day 2-3: 1 patch X1/d, Days 4-5: no patchIdentical in shape and texture to treatment patch | Drug | B |
Primary outcome
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
Time frame: 5 days
2 secondary outcomes
frequency and severity of any adverse event
Time frame: 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.
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oded Yaniv, DMD principal investigator
Izun Pharma Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transmucosal Herbal Periodontal Patch (THPP) in people with Gingival Inflammation in Diabetic Patients, run by Izun Pharma Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.