PeriodontitisPhase 2NCT00918060
Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts as an Adjunct in Peridontitis Treatment
A Phase 2 study testing Camella sinensis gel in people with Periodontitis, run by Mahidol University.
Trial summary
The purpose of this study is to evaluate clinical result including plaque index, gingival inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after used locally-delivered gel containing Camella sinensis extracts as an adjunctive treatment in periodontal therapy Read more about this study
- Who is it for?
- Ages 34 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Camella sinensis gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Dec 2010
- 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 34 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects have sound tooth with pocket depth = or > 5 mm. without caries, restoration, mobility and furcation involvement
- no systemic complicated factors
- no allergy to green tea or product of green tea
- signing in informed consent form
Who cannot join
- smoking
- pregnancy or lactation
- antibiotic premedication or antibiotic intake in previous 3 month
About this study
Official title: Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts
The purpose of this study is to evaluate clinical result including plaque index, gingival inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after used locally-delivered gel containing Camella sinensis extracts as an adjunctive treatment in periodontal therapy
- Conditions
- Periodontitis
- Being tested
- Camella sinensis gel
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camella sinensis gelDrug
clinical effect of locally-delivered gel between Camella sinensis and placebo
| Study group | Role | What they receive |
|---|---|---|
| gel a | Experimental | Not described Receives: Drug: Camella sinensis gel |
| gel b | Placebo comparator | Not described Receives: Drug: Camella sinensis gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
pocket depth reduction, clinical attachment level gain, gingival index, bleeding score
Measured: baseline, 1, 3 and 6 month after gel had loaded
Secondary outcomes (1)
plaque index
Measured: baseline, 1, 3, and 6 month after gel had loaded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startFeb 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Kanyawat Rattanasuwan, Study director, Department of Oral Medicine, Mahidol UniversityKanyawat Rattanasuwan, Study chair, Maha Chakri Sirindhorn Dental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918060
- Sponsor's protocol ID
- COA. No. MU-IRB 2008/153.0511
- Status last verified
- Oct 2010
- First submitted
- 10 Jun 2009
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rattanasuwan K, Rassameemasmaung S, Sangalungkarn V, Komoltri C. Clinical effect of locally delivered gel containing green tea extract as an adjunct to non-surgical periodontal treatment. Odontology. 2016 Jan;104(1):89-97. doi: 10.1007/s10266-014-0190-1. Epub 2014 Dec 19.
PubMed 25523604
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts
- ClinicalTrials.gov ID
- NCT00918060
- Acronym / sponsor ID
- COA. No. MU-IRB 2008/153.0511
- Conditions
- Periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 11 Jun 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.
The purpose of this study is to evaluate clinical result including plaque index, gingival inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after used locally-delivered gel containing Camella sinensis extracts as an adjunctive treatment in periodontal therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gel a | Experimental | Drug: Camella sinensis gel |
| gel b | Placebo comparator | Drug: Camella sinensis gel |
Who may qualify
- Ages
- 34 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subjects have sound tooth with pocket depth = or > 5 mm. without caries, restoration, mobility and furcation involvement
- no systemic complicated factors
- no allergy to green tea or product of green tea
- signing in informed consent form
Key exclusion criteria (3 listed)
- smoking
- pregnancy or lactation
- antibiotic premedication or antibiotic intake in previous 3 month
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 |
|---|---|---|
| Camella sinensis gelclinical effect of locally-delivered gel between Camella sinensis and placebo | Drug | gel a, gel b |
Primary outcome
pocket depth reduction, clinical attachment level gain, gingival index, bleeding score
Time frame: baseline, 1, 3 and 6 month after gel had loaded
1 secondary outcome
plaque index
Time frame: baseline, 1, 3, and 6 month after gel had loaded
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
- Derived from this study: PubMed 25523604Rattanasuwan K, Rassameemasmaung S, Sangalungkarn V, Komoltri C. Clinical effect of locally delivered gel containing green tea extract as an adjunct to non-surgical periodontal treatment. Odontology. 2016 Jan;104(1):89-97. doi: 10.1007/s10266-014-0190-1. Epub 2014 Dec 19.
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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.
Kanyawat Rattanasuwan study director
Department of Oral Medicine, Mahidol University
Kanyawat Rattanasuwan study chair
Maha Chakri Sirindhorn Dental Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camella sinensis gel in people with Periodontitis, run by Mahidol University.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Oct 2010. 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. 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?
Results are not available in the source record.
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?
pocket depth reduction, clinical attachment level gain, gingival index, bleeding score (time frame: baseline, 1, 3 and 6 month after gel had loaded). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00918060, which also lists 1 linked publication.
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 13 Oct 2010.