- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04767269
Efficacy of Cuminum Cyminum Herbal =Preparation in Inhibition of Plaque and Gingivitis.
February 22, 2021 updated by: DR SURINDER SACHDEVA, Maharishi Markendeswar University (Deemed to be University)
Efficacy of Cuminum Cyminum Herbal Preparation in Inhibition of Plaque and Gingivitis
Present work was to investigate the possible efficacy of 0.2% cuminum cyminum herbal preparation as an antiplaque and antigingivitis agent when compared with chlorhexidine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To evaluate and compare the efficacy of 0.2% cuminum cyminum herbal preparation against 0.2% chlorhexidine by various clinical parameters i.e. plaque index, gingival index and sulcus bleeding index.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Haryana
-
Ambāla, Haryana, India, 133207
- Department of Periodontology, M.M. College of Dental Sciences and Research.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- volunteers with minimum 20 natural teeth without restoration.
- cooperative
- motivated and committed to participate in the trial period.
Exclusion Criteria:
- Antibiotic or anti-inflammatory therapy in previous month.
- Any known allergy/ hypersensitivity to any product used in trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cuminum cyminum mouthwash
cuminum cyminum mouthwash in chronic gingivitis patients
|
Cuminum Cyminum mouthwash in chronic gingivitis patients
Other Names:
|
Active Comparator: herbal mouthwash
herbal mouthwash in chronic gingivitis patients
|
herbal mouthwash in chronic gingivitis patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PLAQUE INDEX
Time Frame: changes from baseline to 8 days
|
PLAQUE INDEX: Turesky-Gilmore-Glickman Modification of Quigley Hein 1962
|
changes from baseline to 8 days
|
Gingival Index
Time Frame: changes from baseline to 8 days
|
Gingival Index: Loe H ans Silness 1963
|
changes from baseline to 8 days
|
Bleeding on probing
Time Frame: changes from baseline to 8 days
|
Bleeding on probing: Muhlemann HR and Son 1971
|
changes from baseline to 8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: surinder sachdeva, M.D.S., professor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Southern EN, McCombs GB, Tolle SL, Marinak K. The comparative effects of 0.12% chlorhexidine and herbal oral rinse on dental plaque-induced gingivitis. J Dent Hyg. 2006 Winter;80(1):12. Epub 2006 Jan 1.
- Salgado AD, Maia JL, Pereira SL, de Lemos TL, Mota OM. Antiplaque and antigingivitis effects of a gel containing Punica granatum Linn extract: a double-blind clinical study in humans. J Appl Oral Sci. 2006 Jun;14(3):162-6. doi: 10.1590/s1678-77572006000300003.
- Bettaieb I, Bourgou S, Wannes WA, Hamrouni I, Limam F, Marzouk B. Essential oils, phenolics, and antioxidant activities of different parts of cumin (Cuminum cyminum L.). J Agric Food Chem. 2010 Oct 13;58(19):10410-8. doi: 10.1021/jf102248j.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
January 15, 2021
Study Completion (Actual)
January 31, 2021
Study Registration Dates
First Submitted
February 9, 2021
First Submitted That Met QC Criteria
February 20, 2021
First Posted (Actual)
February 23, 2021
Study Record Updates
Last Update Posted (Actual)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MaharishiMu2012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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