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NCT00554034
The Effect of Herbal Extracts on Inflammatory Enzymes in the Gingiva: a Dose Finding Study.
Phase 2 trial testing periopatch in Gingivitis in 60 participants. Completed in 1 March 2009.
1 March 2009
Quick facts
| Lead sponsor | Shaare Zedek Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 November 2007 |
| Primary completion | 1 March 2009 |
| Estimated completion | 1 March 2009 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- periopatch — full drug profile →
Conditions studied
- Gingivitis — all drugs for Gingivitis →
Sponsor
Shaare Zedek Medical Center
Who can join
Adults 18 to 75, any sex, with Gingivitis. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
To determine the correct dosing of the herbal Patch [THPP]
Time frame: 3 months
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00554034
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gingivitis
Currently open trials in the same condition.
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- NCT07164989 — Motivational Interviewing to Improve Oral Hygiene in Adolescent Orthodontic Patients · NA · active not recruiting
- NCT07530978 — ORAL HYGIENE, PERIODONTAL STATUS AND QUALITY OF LIFE · recruiting
Other Shaare Zedek Medical Center trials
Trials by the same sponsor.
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- NCT05841953 — The Use of Electrical Stimulation to Increase Anal Pressures · NA · unknown
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00554034 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shaare Zedek Medical Center
- Last refreshed: 19 December 2010
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00554034.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing