GingivitisNCT01956656
Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis
A study testing lotus leaf mouthwash in people with Gingivitis, run by Sri Hasanamba Dental College and Hospital at 1 site in India.
Trial summary
Due to difficulties in maintenance of an effective mechanical oral hygiene regime, effective chemical adjunctive measures will likely significantly contribute to overall oral health, the function of which should be to augment mechanical plaque control. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- lotus leaf mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2013to Dec 2013
- Phase
- Interventional
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects willing to comply with the study protocol \& instruction.
- Clinically diagnosed with chronic gingivitis.
- No history of allergies to herbal formulations.
- No history of periodontal therapy within the previous 6 months.
- No history of antibiotic therapy within the previous 6 months.
Who cannot join
- Any systemic diseases
- Use of tobacco or tobacco related products
- Pregnant woman and lactating mothers
- Subjects that had used any type of antibacterial mouthrinse within 4 weeks of recruitment in to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis: A 4 Day Double Blind Clinico-Microbiological Trial.
Due to difficulties in maintenance of an effective mechanical oral hygiene regime, effective chemical adjunctive measures will likely significantly contribute to overall oral health, the function of which should be to augment mechanical plaque control. Traditionally, in Chinese medicine the lotus leaf has been used for treating gingival inflammation. An extract of lotus leaves have demonstrated significant antibacterial activity against some of the periodontopathogens.
Read the detailed description
The objective of the present research is to evaluate the efficacy of a lotus leaf mouth wash in management of plaque induced gingivitis.
Study design: 30 systemically healthy volunteers will be randomly allocated into two arms
Arm A: Lotus leaf mouth wash (aqueous) group [Test group] Arm B: Placebo mouth wash group [Control group]
All the volunteers are instructed to refrain from tooth brushing 24 hours before the examination. Clinical parameters (plaque index, bleeding index and gingival index)will be measured and the plaque samples are collected from subjects from each group for microbiological analysis. All the participants will undergo scaling, and they were instructed to refrain from tooth cleaning procedures and were advised to use the prescribed mouth wash twice daily for 4 days. All volunteers were recalled on 5th day for clinical and microbiological analysis. Statistical analysis and results are awaited
- Conditions
- Gingivitis
- Being tested
- lotus leaf mouthwash
- Keywords
- lotus leaf, mouthwash, gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lotus leaf mouthwashDrug
Also called Lotus mouthwash
Saline mouthwash to be used for 4 days twice daily by one group the other group the lotus leaf mouthwash
| Study group | Role | What they receive |
|---|---|---|
| lotus leaf mouthwash | Placebo comparator | 10 ml mouthwash to be used for 4days twice daily Receives: Drug: lotus leaf mouthwash |
| placebo mouthwash | Placebo comparator | 10 ml mouthwash to be used for 4 days twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque induced gingivitis
Gingivitis is measured using, Sillness\&Loe(1964):Plaque Index Gingival index(GI)-Loe\&Sillness(1963) before and after dispensing of mouthwash.
Measured: 4 days
Secondary outcomes (1)
Grams Staining of the plaque collected from the subjects
Supra-gingival plaque sample are taken microbiological(gram staining)analysis before and after mouthwash dispensing.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sri Hasanamba Dental College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Gopi Kishore.C.R., Sri Hasanamba Dental College and Hospital
- Investigators
- Dr Ravindra Shivamurthy, MDS, Principal investigator, Sri Hasanamba Dental College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956656
- Sponsor's protocol ID
- z59p5gy7
- Status last verified
- Dec 2013
- First submitted
- 17 Sep 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis: A 4 Day Double Blind Clinico-Microbiological Trial.
- ClinicalTrials.gov ID
- NCT01956656
- Acronym / sponsor ID
- z59p5gy7
- Conditions
- Gingivitis
- Keywords
- lotus leaf, mouthwash, gingivitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sri Hasanamba Dental College and HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 8 Oct 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.
Due to difficulties in maintenance of an effective mechanical oral hygiene regime, effective chemical adjunctive measures will likely significantly contribute to overall oral health, the function of which should be to augment mechanical plaque control. Traditionally, in Chinese medicine the lotus leaf has been used for treating gingival inflammation. An extract of lotus leaves have demonstrated significant antibacterial activity against some of the periodontopathogens.
Detailed description
The objective of the present research is to evaluate the efficacy of a lotus leaf mouth wash in management of plaque induced gingivitis.
Study design: 30 systemically healthy volunteers will be randomly allocated into two arms
Arm A: Lotus leaf mouth wash (aqueous) group [Test group] Arm B: Placebo mouth wash group [Control group]
All the volunteers are instructed to refrain from tooth brushing 24 hours before the examination. Clinical parameters (plaque index, bleeding index and gingival index)will be measured and the plaque samples are collected from subjects from each group for microbiological analysis. All the participants will undergo scaling, and they were instructed to refrain from tooth cleaning procedures and were advised to use the prescribed mouth wash twice daily for 4 days. All volunteers were recalled on 5th day for clinical and microbiological analysis. Statistical analysis and results are awaited
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lotus leaf mouthwash | Placebo comparator | Drug: lotus leaf mouthwash10 ml mouthwash to be used for 4days twice daily |
| placebo mouthwash | Placebo comparator | –10 ml mouthwash to be used for 4 days twice daily |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects willing to comply with the study protocol \& instruction.
- Clinically diagnosed with chronic gingivitis.
- No history of allergies to herbal formulations.
- No history of periodontal therapy within the previous 6 months.
- No history of antibiotic therapy within the previous 6 months.
Key exclusion criteria (4 listed)
- Any systemic diseases
- Use of tobacco or tobacco related products
- Pregnant woman and lactating mothers
- Subjects that had used any type of antibacterial mouthrinse within 4 weeks of recruitment in to the 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 |
|---|---|---|
| lotus leaf mouthwashAlso: Lotus mouthwashSaline mouthwash to be used for 4 days twice daily by one group the other group the lotus leaf mouthwash | Drug | lotus leaf mouthwash |
Primary outcome
Plaque induced gingivitis
Time frame: 4 days
Gingivitis is measured using, Sillness\&Loe(1964):Plaque Index Gingival index(GI)-Loe\&Sillness(1963) before and after dispensing of mouthwash.
1 secondary outcome
Grams Staining of the plaque collected from the subjects
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
Related trials for Gingivitis
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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.
Dr Ravindra Shivamurthy, 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 study testing lotus leaf 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 5 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: status not confirmed, as of the sponsor's last update on 11 Dec 2013. 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. 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.
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?
Plaque induced gingivitis (time frame: 4 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 11 Dec 2013.