Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis
1 other identifier
interventional
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 11, 2013
December 1, 2013
3 months
September 17, 2013
December 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plaque induced gingivitis
Gingivitis is measured using, Sillness\&Loe(1964):Plaque Index Gingival index(GI)-Loe\&Sillness(1963) before and after dispensing of mouthwash.
4 days
Secondary Outcomes (1)
Grams Staining of the plaque collected from the subjects
4 days
Study Arms (2)
lotus leaf mouthwash
PLACEBO COMPARATOR10 ml mouthwash to be used for 4days twice daily
placebo mouthwash
PLACEBO COMPARATOR10 ml mouthwash to be used for 4 days twice daily
Interventions
Saline mouthwash to be used for 4 days twice daily by one group the other group the lotus leaf mouthwash
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sri Hasanamba Dental College and Hospital
Hassan, Karnataka, 573202, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Ravindra Shivamurthy, MDS
Sri Hasanamba Dental College and Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- P.G. student
Study Record Dates
First Submitted
September 17, 2013
First Posted
October 8, 2013
Study Start
September 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 11, 2013
Record last verified: 2013-12