NCT00972803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
Last Updated

September 9, 2009

Status Verified

February 1, 2007

First QC Date

September 8, 2009

Last Update Submit

September 8, 2009

Conditions

Keywords

gingivitisdental plaquemouthrinse

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • 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

Study Arms (3)

pistacia Mutica

EXPERIMENTAL

The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.

Drug: pistacia Mutica extract

placebo

PLACEBO COMPARATOR

The subjects were asked to use a mouthwash containing Placebo twice a day for 4 days.

Drug: Placebo

Chlorhexidine

ACTIVE COMPARATOR

The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.

Drug: Chlorhexidine

Interventions

The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.

pistacia Mutica

The subjects were asked to use a placebo mouthwash twice a day for 4 days.

placebo

The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.

Chlorhexidine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • had merely gingivitis (pocket depth≤3 mm, no attachment loss)
  • without any fixed or removable oral appliances

You may not qualify if:

  • Individuals who had a history of any relevant systemic diseases
  • Individuals who had a history of any drug usage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drug Applied Science Center, tabriz Univ. of Medical Sciences

Tabriz, East Azerbaijan Province, Iran

Location

MeSH Terms

Conditions

GingivitisDental Plaque

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Reza Pourabbas, DDS,MSD

    Tabriz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

May 1, 2008

Study Completion

May 1, 2009

Last Updated

September 9, 2009

Record last verified: 2007-02

Locations