GingivitisPhase 2NCT00972803
The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms
A Phase 2 study testing pistacia Mutica extract and Chlorhexidine in people with Gingivitis, run by Tabriz University at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- pistacia Mutica extract and Chlorhexidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteIran
- Study dates
- May 2008to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- had merely gingivitis (pocket depth≤3 mm, no attachment loss)
- without any fixed or removable oral appliances
Who cannot join
- Individuals who had a history of any relevant systemic diseases
- Individuals who had a history of any drug usage
Trial locations and contacts
1 site in 1 country.
Iran1 site
Drug Applied Science Center, tabriz Univ. of Medical Sciences
Tabriz, East Azerbaijan Province
About this study
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.
- Conditions
- Gingivitis
- Being tested
- pistacia Mutica extract, Placebo, Chlorhexidine
- Keywords
- gingivitis, dental plaque, mouthrinse
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pistacia Mutica extractDrug
The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.
PlaceboDrug
The subjects were asked to use a placebo mouthwash twice a day for 4 days.
ChlorhexidineDrug
The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| pistacia Mutica | Experimental | The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days. Receives: Drug: pistacia Mutica extract |
| placebo | Placebo comparator | The subjects were asked to use a mouthwash containing Placebo twice a day for 4 days. Receives: Drug: Placebo |
| Chlorhexidine | Active comparator | The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days. Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of pistacia Mutica extract (PM) on de novo plaque formation.
Measured: 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
Measured: In a 4 days experimental periods followed by a 10 days wash-out periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMay 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabriz University
- Sponsor type
- University, hospital or other
- Investigators
- Reza Pourabbas, DDS,MSD, Principal investigator, Tabriz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972803
- Sponsor's protocol ID
- 8660
- Status last verified
- Feb 2007
- First submitted
- 8 Sep 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms
- ClinicalTrials.gov ID
- NCT00972803
- Acronym / sponsor ID
- 8660
- Conditions
- Gingivitis
- Keywords
- gingivitis, dental plaque, mouthrinse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tabriz UniversityUniversity, hospital or other
- Study start
- May 2008
- Study completion
- May 2009 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pistacia Mutica | Experimental | Drug: pistacia Mutica extractThe subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days. |
| placebo | Placebo comparator | Drug: PlaceboThe subjects were asked to use a mouthwash containing Placebo twice a day for 4 days. |
| Chlorhexidine | Active comparator | Drug: ChlorhexidineThe subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- had merely gingivitis (pocket depth≤3 mm, no attachment loss)
- without any fixed or removable oral appliances
Key exclusion criteria (2 listed)
- Individuals who had a history of any relevant systemic diseases
- Individuals who had a history of any drug usage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pistacia Mutica extractThe subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days. | Drug | pistacia Mutica |
| PlaceboThe subjects were asked to use a placebo mouthwash twice a day for 4 days. | Drug | placebo |
| ChlorhexidineThe subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days. | Drug | Chlorhexidine |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Pourabbas, DDS,MSD principal investigator
Tabriz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pistacia Mutica extract and Chlorhexidine in people with Gingivitis, run by Tabriz University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2009.