GingivitisPhase 2NCT00554034
Effect of Herbal Extracts on Gingival Inflammation
A Phase 2 study testing periopatch in people with Gingivitis, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- periopatch
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2007to Mar 2009
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 -75.
- Severe localized gingival inflammation [GI index 2 or greater
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Herbal Extracts on Inflammatory Enzymes in the Gingiva: a Dose Finding Study.
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.
- Conditions
- Gingivitis
- Being tested
- periopatch
- Keywords
- gingivitis, localized treatment
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periopatchDrug
Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the correct dosing of the herbal Patch [THPP]
Measured: 3 months
Secondary outcomes (1)
To demonstarte the safety of THPP on the gingival tissue and in the oral cavity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Menachem Oberbaum, M.D., Principal investigator, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554034
- Sponsor's protocol ID
- Protocol C-4
- Status last verified
- Apr 2009
- First submitted
- 15 Oct 2007
- Last updated
- 21 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Herbal Extracts on Inflammatory Enzymes in the Gingiva: a Dose Finding Study.
- ClinicalTrials.gov ID
- NCT00554034
- Acronym / sponsor ID
- Protocol C-4
- Conditions
- Gingivitis
- Keywords
- gingivitis, localized treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Nov 2007 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 -75.
- Severe localized gingival inflammation [GI index 2 or greater
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| periopatchPatients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study. | Drug | – |
Primary outcome
To determine the correct dosing of the herbal Patch [THPP]
Time frame: 3 months
1 secondary outcome
To demonstarte the safety of THPP on the gingival tissue and in the oral cavity
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2010.
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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.
Menachem Oberbaum, M.D. principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel
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 periopatch in people with Gingivitis, run by Shaare Zedek Medical Center 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 21 Dec 2010. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the correct dosing of the herbal Patch [THPP] (time frame: 3 months). 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 21 Dec 2010.