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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972803
• Other study ID #: 8660
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2009
• Last updated: September 8, 2009
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: February 2007
• Source: Tabriz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2009
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis

Intervention

Drug:
• pistacia Mutica extract
The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.
• Placebo
The subjects were asked to use a placebo mouthwash twice a day for 4 days.
• Chlorhexidine
The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Drug Applied Science Center, tabriz Univ. of Medical Sciences	Tabriz	East azarbaijan

Sponsors (1)

Lead Sponsor	Collaborator
Tabriz University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effects of pistacia Mutica extract (PM) on de novo plaque formation.		In a 4 days experimental periods followed by a 10 days wash-out periods.	Yes
Secondary	staining effects of pistacia Mutica extract in comparison to placebo or Chlorhexidine		In a 4 days experimental periods followed by a 10 days wash-out periods	Yes