GingivitisPhase 2NCT00932347
Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor
A Phase 2 study testing Camellia sinensis mouthwash in people with Gingivitis and Halitosis, run by Mahidol University at 2 sites in Thailand.
Trial summary
The purpose of this study is to determine effect of Mouthwash containing Camellia sinensis extracts on oral malodor and gingival inflammation in gingivitis subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Halitosis
- What is being tested?
- Camellia sinensis mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesThailand
- Study dates
- Jan 2008to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 20 teeth
- clinical diagnosis as plaque induced gingivitis
- having over 80 ppb of volatile sulfur compounds in mouth air
Who cannot join
- smoker
- denture wearer
- having systemic diseases or oral pathology
- taking antibiotics 1 month prior to study
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University
Bangkok, Bangkok, 10400
Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University
Bangkok, 10400
About this study
Official title: Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor, Plaque and Papillary Bleeding Indices in Gingivitis Patients.
The purpose of this study is to determine effect of Mouthwash containing Camellia sinensis extracts on oral malodor and gingival inflammation in gingivitis subjects.
Read the detailed description
At baseline, level of volatile sulfur compounds (VSC) in mouth air, Plaque Index and Papillary Bleeding Index will be recorded. Gingivitis subjects will be asked to rinse with Camellia sinensis mouthwash or placebo mouthwash. VSC level will be measured at 30 minutes and 3 hours post-rinsing. For the following 4 weeks, subjects will be rinsed with the assigned mouthwash twice daily after toothbrushing. All parameter will be recorded again at Day 28.
- Conditions
- Gingivitis, Halitosis
- Being tested
- Camellia sinensis mouthwash, Placebo mouthwash
- Keywords
- Camellia sinensis, volatile sulfur compounds
- Medical subject headings
- Gingivitis, Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camellia sinensis mouthwashDrug
Also called Green tea mouthwash
mouthrinsing, 2 times/day, for 28 days
Placebo mouthwashDrug
Also called placebo
mouthrinsing, 2 times/day, for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Mouthwash A | Experimental | Mouthwash A: Camellia sinensis mouthwash Receives: Drug: Camellia sinensis mouthwash |
| Mouthwash B | Placebo comparator | Mouthwash B: Placebo mouthwash Receives: Drug: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of volatile sulfur compounds in mouth air (part per billion)
Measured: baseline, 30 minutes, 3 hours, 28 days
Secondary outcomes (1)
Papillary bleeding index
Measured: baseline, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startJan 2008
- Primary completionSep 2009
- Study completionDec 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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Supanee Rassameemasmaung, Ph.D, Principal investigator, Department of Oral Medicine, Faculty of Dentistry, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932347
- Sponsor's protocol ID
- COA. No. MU-IRB 2008/177.1211
- Status last verified
- Jul 2011
- First submitted
- 1 Jul 2009
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor, Plaque and Papillary Bleeding Indices in Gingivitis Patients.
- ClinicalTrials.gov ID
- NCT00932347
- Acronym / sponsor ID
- COA. No. MU-IRB 2008/177.1211
- Conditions
- Gingivitis, Halitosis
- Keywords
- Camellia sinensis, volatile sulfur compounds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Jul 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 determine effect of Mouthwash containing Camellia sinensis extracts on oral malodor and gingival inflammation in gingivitis subjects.
Detailed description
At baseline, level of volatile sulfur compounds (VSC) in mouth air, Plaque Index and Papillary Bleeding Index will be recorded. Gingivitis subjects will be asked to rinse with Camellia sinensis mouthwash or placebo mouthwash. VSC level will be measured at 30 minutes and 3 hours post-rinsing. For the following 4 weeks, subjects will be rinsed with the assigned mouthwash twice daily after toothbrushing. All parameter will be recorded again at Day 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mouthwash A | Experimental | Drug: Camellia sinensis mouthwashMouthwash A: Camellia sinensis mouthwash |
| Mouthwash B | Placebo comparator | Drug: Placebo mouthwashMouthwash B: Placebo mouthwash |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 20 teeth
- clinical diagnosis as plaque induced gingivitis
- having over 80 ppb of volatile sulfur compounds in mouth air
Key exclusion criteria (4 listed)
- smoker
- denture wearer
- having systemic diseases or oral pathology
- taking antibiotics 1 month prior to study
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 |
|---|---|---|
| Camellia sinensis mouthwashAlso: Green tea mouthwashmouthrinsing, 2 times/day, for 28 days | Drug | Mouthwash A |
| Placebo mouthwashAlso: placebomouthrinsing, 2 times/day, for 28 days | Drug | Mouthwash B |
Primary outcome
level of volatile sulfur compounds in mouth air (part per billion)
Time frame: baseline, 30 minutes, 3 hours, 28 days
1 secondary outcome
Papillary bleeding index
Time frame: baseline, 28 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 22 Jul 2011.
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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.
Supanee Rassameemasmaung, Ph.D principal investigator
Department of Oral Medicine, Faculty of Dentistry, Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camellia sinensis mouthwash in people with Gingivitis and Halitosis, run by Mahidol University at 2 sites in Thailand.
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 3 inclusion and 4 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 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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?
level of volatile sulfur compounds in mouth air (part per billion) (time frame: baseline, 30 minutes, 3 hours, 28 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 22 Jul 2011.