Back to resultsThe Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms
Primary Purpose
Gingivitis
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
pistacia Mutica extract
Placebo
Chlorhexidine
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis focused on measuring gingivitis, dental plaque, mouthrinse
Eligibility 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
Sites / Locations
- Drug Applied Science Center, tabriz Univ. of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
pistacia Mutica
placebo
Chlorhexidine
Arm Description
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 Placebo twice a day for 4 days.
The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.
Outcomes
Primary Outcome Measures
The effects of pistacia Mutica extract (PM) on de novo plaque formation.
Secondary Outcome Measures
staining effects of pistacia Mutica extract in comparison to placebo or Chlorhexidine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00972803
Brief Title
The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms
Official Title
The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tabriz University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
gingivitis, dental plaque, mouthrinse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pistacia Mutica
Arm Type
Experimental
Arm Description
The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The subjects were asked to use a mouthwash containing Placebo twice a day for 4 days.
Arm Title
Chlorhexidine
Arm Type
Active Comparator
Arm Description
The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.
Intervention Type
Drug
Intervention Name(s)
pistacia Mutica extract
Intervention Description
The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The subjects were asked to use a placebo mouthwash twice a day for 4 days.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Intervention Description
The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Pourabbas, DDS,MSD
Organizational Affiliation
Tabriz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drug Applied Science Center, tabriz Univ. of Medical Sciences
City
Tabriz
State/Province
East azarbaijan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms
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