GingivitisPhase 3BlackteaNCT02545244
Effectiveness of Black Tea Mouthwash on Plaque Formation
A Phase 3 study testing Black Tea, Green Tea and 0.12% Chlorhexidine Mouthwash. in people with Gingivitis, run by Sri Hasanamba Dental College and Hospital at 1 site in India.
Trial summary
The study was conducted to measure the effectiveness of Black Tea in reducing the deposits on teeth. It also compares the effect between use of black tea mouthwash and green tea mouthwash to that of chlorhexidine in reducing plaque deposition on teeth in a two weeks long clinical trial among adults of 18-40 years of… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Black Tea, Green Tea and 0.12% Chlorhexidine Mouthwash.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2015to Jun 2015
- Phase
- Phase 3
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years old. subjects with at least 20 natural teeth. diagnosed with chronic generalized plaque induced gingivitis.
Who cannot join
- subjects with systemic illness. subjects on antibiotic in the previous six months. subjects with allergy to tea. subjects on medications with effect on periodontium (Eg:anti-osteoporotic drugs).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Effectiveness of Black Tea Mouthwash on Plaque Formation:A Randomized Controlled Clinical Trial"
The study was conducted to measure the effectiveness of Black Tea in reducing the deposits on teeth. It also compares the effect between use of black tea mouthwash and green tea mouthwash to that of chlorhexidine in reducing plaque deposition on teeth in a two weeks long clinical trial among adults of 18-40 years of age.
Read the detailed description
The study titled "Effectiveness of Black Tea Mouthwash on Plaque formation: A Randomized Controlled Clinical Trial" conducted at Department of Periodontics,during February 2015 till July 2015 included three interventional arms with 15 subjects each who had chronic generalized plaque-induced gingivitis. All subjects underwent scaling and randomly allocated into three groups as Black tea,Green tea and Chlorhexidine. Those in black tea, green tea and Chlorhexidine groups advised to rinse with 0.5% Black tea, 0.5% green tea and 0.12% Chlorhexidine aqueous based solutions for 30 seconds twice daily half an hour after brushing teeth respectively. Gingival Index (Loe and Silness 1963) and Plaque Index (Silness and Loe, 1964) recorded at baseline and 2 weeks after intervention in all subjects. Results were analyzed using SPSS Statistical software version 20.
- Conditions
- Gingivitis
- Being tested
- Black Tea, Green Tea, 0.12% Chlorhexidine Mouthwash.
- Keywords
- Gingivitis, Black Tea, Green Tea,Chlorhexidine, Biofilm,
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black TeaDietary supplement
0.5% Black Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.
Green TeaDietary supplement
0.5% Green Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.
0.12% Chlorhexidine Mouthwash.Drug
5mL of 0.12% Chlorhexidine used as mouthwash twice daily for two weeks after scaling of teeth.
| Study group | Role | What they receive |
|---|---|---|
| Black Tea | Experimental | 0.5% Black Tea as Mouthwash, 5mL to be used twice daily for 30 seconds undiluted. Receives: Dietary Supplement: Black Tea |
| Green Tea | Active comparator | 0.5% Green Tea as Mouthwash, 5mL to be used twice daily for 30 seconds undiluted. Receives: Dietary Supplement: Green Tea |
| Chlorhexidine | Active comparator | 0.12% Chlorhexidine Mouthwash 5mL to be used twice daily. Receives: Drug: 0.12% Chlorhexidine Mouthwash. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index (Silness and Loe 1964)
Plaque Index at baseline and two weeks after scaling and use of mouthwash
Measured: two weeks
Secondary outcomes (1)
Gingival Index(Loe and Silness 1963)
Measure Gingival Index at baseline and two weeks after scaling and use of mouthwash
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJun 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sri Hasanamba Dental College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Smitha K.B, Sri Hasanamba Dental College and Hospital
- Investigators
- ShivaMurthy Ravindra, MDS, Principal investigator, Sri Hasanamba Dental College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545244
- Sponsor's protocol ID
- SHDCH/2015-16/1107
- Acronym
- Blacktea
- Status last verified
- Sep 2015
- First submitted
- 7 Sep 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effectiveness of Black Tea Mouthwash on Plaque Formation:A Randomized Controlled Clinical Trial"
- ClinicalTrials.gov ID
- NCT02545244
- Acronym / sponsor ID
- Blacktea / SHDCH/2015-16/1107
- Conditions
- Gingivitis
- Keywords
- Gingivitis, Black Tea, Green Tea,Chlorhexidine, Biofilm,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sri Hasanamba Dental College and HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Sep 2015 (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 study was conducted to measure the effectiveness of Black Tea in reducing the deposits on teeth. It also compares the effect between use of black tea mouthwash and green tea mouthwash to that of chlorhexidine in reducing plaque deposition on teeth in a two weeks long clinical trial among adults of 18-40 years of age.
Detailed description
The study titled "Effectiveness of Black Tea Mouthwash on Plaque formation: A Randomized Controlled Clinical Trial" conducted at Department of Periodontics,during February 2015 till July 2015 included three interventional arms with 15 subjects each who had chronic generalized plaque-induced gingivitis. All subjects underwent scaling and randomly allocated into three groups as Black tea,Green tea and Chlorhexidine. Those in black tea, green tea and Chlorhexidine groups advised to rinse with 0.5% Black tea, 0.5% green tea and 0.12% Chlorhexidine aqueous based solutions for 30 seconds twice daily half an hour after brushing teeth respectively. Gingival Index (Loe and Silness 1963) and Plaque Index (Silness and Loe, 1964) recorded at baseline and 2 weeks after intervention in all subjects. Results were analyzed using SPSS Statistical software version 20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Black Tea | Experimental | Dietary Supplement: Black Tea0.5% Black Tea as Mouthwash, 5mL to be used twice daily for 30 seconds undiluted. |
| Green Tea | Active comparator | Dietary Supplement: Green Tea0.5% Green Tea as Mouthwash, 5mL to be used twice daily for 30 seconds undiluted. |
| Chlorhexidine | Active comparator | Drug: 0.12% Chlorhexidine Mouthwash.0.12% Chlorhexidine Mouthwash 5mL to be used twice daily. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-40 years old. subjects with at least 20 natural teeth. diagnosed with chronic generalized plaque induced gingivitis.
Key exclusion criteria (1 listed)
- subjects with systemic illness. subjects on antibiotic in the previous six months. subjects with allergy to tea. subjects on medications with effect on periodontium (Eg:anti-osteoporotic drugs).
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 |
|---|---|---|
| Black Tea0.5% Black Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth. | Dietary supplement | Black Tea |
| Green Tea0.5% Green Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth. | Dietary supplement | Green Tea |
| 0.12% Chlorhexidine Mouthwash.5mL of 0.12% Chlorhexidine used as mouthwash twice daily for two weeks after scaling of teeth. | Drug | Chlorhexidine |
Primary outcome
Plaque Index (Silness and Loe 1964)
Time frame: two weeks
Plaque Index at baseline and two weeks after scaling and use of mouthwash
1 secondary outcome
Gingival Index(Loe and Silness 1963)
Time frame: two weeks
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 2015.
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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.
ShivaMurthy Ravindra, MDS principal investigator
Sri Hasanamba Dental College and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Black Tea, Green Tea and 0.12% Chlorhexidine Mouthwash. in people with Gingivitis, run by Sri Hasanamba Dental College and Hospital at 1 site in India.
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 9 Sep 2015. 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 India. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Plaque Index (Silness and Loe 1964) (time frame: two weeks). 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 2015.