Periodontal DiseaseNCT01900535
Evaluation and Comparison of the Efficacy of Triphala Mouthwash and 0.2% Chlorhexidine
An observational study of Periodontal Disease, run by Tatyasaheb Kore Dental College.
Trial summary
The purpose of this study is to evaluate the usefulness of triphala mouthwash in comparison with the gold standard chlorhexidine in hospitalized and periodontally diseased patients. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Periodontal Disease
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Feb 2013
- How long will I take part?
- 15 Days
- Phase
- Observational
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants were selected from patients admitted to three different medical hospitals namely Mahatma Gandhi Hospital, New Pargaon, Sub district Government Hospital, Kodoli and Yeshwant Chavan Hospital, Kodoli
Who may be able to join
- age group of 20-65 years having periodontal diseases according to American Academy of Periodontology (AAP) classification 1999
Who cannot join
- patients seeking any periodontal treatment during the course of study
About this study
Official title: A Randomized Clinical Trial to Evaluate and Compare the Efficacy of Triphala Mouthwash With 0.2% Chlorhexidine in Hospitalized Patients With Periodontal Diseases
The purpose of this study is to evaluate the usefulness of triphala mouthwash in comparison with the gold standard chlorhexidine in hospitalized and periodontally diseased patients.
- Conditions
- Periodontal Disease
- Keywords
- chlorhexidine, gingivitis, periodontitis
- Medical subject headings
- Periodontal Diseases, Gingivitis, Periodontitis
What is being measured
The primary outcome is the main question the study is designed to answer.
plaque index
Measured: 15 days
Secondary outcomes (1)
gingival index
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Tatyasaheb Kore Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ritam S. Naik Tari, Tatyasaheb Kore Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900535
- Sponsor's protocol ID
- TKDC- 11
- Status last verified
- Jul 2013
- First submitted
- 11 Jul 2013
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Evaluate and Compare the Efficacy of Triphala Mouthwash With 0.2% Chlorhexidine in Hospitalized Patients With Periodontal Diseases
- ClinicalTrials.gov ID
- NCT01900535
- Acronym / sponsor ID
- TKDC- 11
- Conditions
- Periodontal Disease
- Keywords
- chlorhexidine, gingivitis, periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tatyasaheb Kore Dental CollegeUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Jul 2013 (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.
The purpose of this study is to evaluate the usefulness of triphala mouthwash in comparison with the gold standard chlorhexidine in hospitalized and periodontally diseased patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants were selected from patients admitted to three different medical hospitals namely Mahatma Gandhi Hospital, New Pargaon, Sub district Government Hospital, Kodoli and Yeshwant Chavan Hospital, Kodoli
Key inclusion criteria (1 listed)
- age group of 20-65 years having periodontal diseases according to American Academy of Periodontology (AAP) classification 1999
Key exclusion criteria (1 listed)
- patients seeking any periodontal treatment during the course of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
plaque index
Time frame: 15 days
1 secondary outcome
gingival index
Time frame: 15 days
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 16 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Disease, run by Tatyasaheb Kore Dental College.
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 1 inclusion and 1 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 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
plaque index (time frame: 15 days). 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 16 Jul 2013.