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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02227485 |
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Date of registration:
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22/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Diabetic Patients
Golnaar |
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Scientific title:
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Evaluation of the Effects of an Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Patients With Diabetes Mellitus |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02227485 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Iran, Islamic Republic of
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Contacts
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Name:
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Mohammad Mahdi Fani, Dentist |
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Address:
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Telephone:
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Email:
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Affiliation:
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Research Center for Traditional Medicine & History of Medicine-Shiraz University of Medical Sciences |
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Name:
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Mesbah Shams, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences |
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Name:
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Massih Seddigh-Rahimabadi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shiraz University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- To have gingivitis
- Controlled diabetes mellitus [FBS<130mg/dl & Glycosilated hemoglobin (A1C)<7%]
- Presence of gingivitis
- Having at least 20 teeth
- No history of hypersensitivity reaction
- Age between 20 to 65 years
- Agreement to participate in the study
Exclusion Criteria:
- History of hypersensitivity reaction
- Smoking
- Systemic diseases (Kidney, liver or rheumatologic diseases)
- To have a pocket depth of more than 5
- Consumption of antibiotics, corticosteroids or nonsteroidal anti-inflammatory drugs in
the past 3 months and during the study period
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gingivitis
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Intervention(s)
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Procedure: Tooth bleaching
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Drug: Chlorhexidine (0.2%)
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Drug: Punica granatum Pleniflora (Golnaar) mouth rinse
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Primary Outcome(s)
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Bleeding Index
[Time Frame: At the beginning, after 2 weeks and after 4 weeks.]
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Modified Gingival Index
[Time Frame: At the beginning, after 2 weeks and after 4 weeks.]
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Pocket Depth
[Time Frame: At the beginning, after 2 weeks and after 4 weeks]
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Plaque Index
[Time Frame: At the beginning, after 2 weeks and after 4 weeks]
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Secondary Outcome(s)
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Number of Participants With Adverse Events
[Time Frame: Up to 2 weeks]
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Satisfaction of Patients
[Time Frame: Up to 2 week]
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Secondary ID(s)
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CT93747064
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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