- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00972803
The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms
September 8, 2009 updated by: Tabriz University
Dental plaque is a well known etiologic factor for gingivitis.
Recently, herbal extracts are a matter of scientific interest to inhibit plaque accumulation on teeth.
The purpose of this study was to evaluate the effects of pistacia Mutica (PM) mouth wash on de novo dental plaque plaque formation, gingival inflammation indices and oral microorganisms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
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
-
-
East azarbaijan
-
Tabriz, East azarbaijan, Iran, Islamic Republic of
- Drug Applied Science Center, tabriz Univ. of Medical Sciences
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- had merely gingivitis (pocket depth≤3 mm, no attachment loss)
- without any fixed or removable oral appliances
Exclusion Criteria:
- Individuals who had a history of any relevant systemic diseases
- Individuals who had a history of any drug usage
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pistacia Mutica
The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.
|
The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.
|
Placebo Comparator: placebo
The subjects were asked to use a mouthwash containing Placebo twice a day for 4 days.
|
The subjects were asked to use a placebo mouthwash twice a day for 4 days.
|
Active Comparator: Chlorhexidine
The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.
|
The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The effects of pistacia Mutica extract (PM) on de novo plaque formation.
Time Frame: In a 4 days experimental periods followed by a 10 days wash-out periods.
|
In a 4 days experimental periods followed by a 10 days wash-out periods.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
staining effects of pistacia Mutica extract in comparison to placebo or Chlorhexidine
Time Frame: In a 4 days experimental periods followed by a 10 days wash-out periods
|
In a 4 days experimental periods followed by a 10 days wash-out periods
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Reza Pourabbas, DDS,MSD, Tabriz University of Medical Sciences
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
May 1, 2008
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
September 8, 2009
First Submitted That Met QC Criteria
September 8, 2009
First Posted (Estimate)
September 9, 2009
Study Record Updates
Last Update Posted (Estimate)
September 9, 2009
Last Update Submitted That Met QC Criteria
September 8, 2009
Last Verified
February 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8660
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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