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

This study has been completed.
Sponsor:
Information provided by:
Tabriz University
ClinicalTrials.gov Identifier:
NCT00972803
First received: September 8, 2009
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Gingivitis
 Drug: pistacia Mutica extract
Drug: Placebo
Drug: Chlorhexidine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tabriz University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: May 2008
Study Completion Date: May 2009
Arms Assigned Interventions
Experimental: pistacia Mutica
The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.
 Drug: pistacia Mutica extract
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.
 Drug: Placebo
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.
 Drug: Chlorhexidine
The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972803

Locations
Iran, Islamic Republic of
Drug Applied Science Center, tabriz Univ. of Medical Sciences
Tabriz, East azarbaijan, Iran, Islamic Republic of
Sponsors and Collaborators
Tabriz University
Investigators
Principal Investigator: Reza Pourabbas, DDS,MSD Tabriz University of Medical sciences
  More Information

No publications provided

Responsible Party: Dr. Reza Pourabbas, Faculty of Dentistry, Tabriz Univ. of Medical Sciences
ClinicalTrials.gov Identifier: NCT00972803     History of Changes
Other Study ID Numbers: 8660
Study First Received: September 8, 2009
Last Updated: September 8, 2009
Health Authority: Iran: Ministry of Health

Keywords provided by Tabriz University:
gingivitis
dental plaque
mouthrinse

Additional relevant MeSH terms:
Dental Plaque
Gingivitis
Inflammation
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases
Mouth Diseases
 Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013