Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00972803
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : September 9, 2009
Sponsor:
Information provided by:
Tabriz University

Tracking Information
First Submitted Date  ICMJE September 8, 2009
First Posted Date  ICMJE September 9, 2009
Last Update Posted Date September 9, 2009
Study Start Date  ICMJE May 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms
Official Title  ICMJE The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gingivitis
Intervention  ICMJE
  • Drug: pistacia Mutica extract
    The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.
  • Drug: Placebo
    The subjects were asked to use a placebo mouthwash twice a day for 4 days.
  • Drug: Chlorhexidine
    The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.
Study Arms  ICMJE
  • Experimental: pistacia Mutica
    The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.
    Intervention: Drug: pistacia Mutica extract
  • Placebo Comparator: placebo
    The subjects were asked to use a mouthwash containing Placebo twice a day for 4 days.
    Intervention: Drug: Placebo
  • Active Comparator: Chlorhexidine
    The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.
    Intervention: Drug: Chlorhexidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2009)
25
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00972803
Other Study ID Numbers  ICMJE 8660
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reza Pourabbas, Faculty of Dentistry, Tabriz Univ. of Medical Sciences
Study Sponsor  ICMJE Tabriz University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Reza Pourabbas, DDS,MSD Tabriz University of Medical Sciences
PRS Account Tabriz University
Verification Date February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP