Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis
Primary Purpose
Gingivitis
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
lotus leaf mouthwash
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis focused on measuring lotus leaf, mouthwash, gingivitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Sri Hasanamba Dental College and Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Placebo Comparator
Arm Label
lotus leaf mouthwash
placebo mouthwash
Arm Description
10 ml mouthwash to be used for 4days twice daily
10 ml mouthwash to be used for 4 days twice daily
Outcomes
Primary Outcome Measures
Plaque induced gingivitis
Gingivitis is measured using, Sillness&Loe(1964):Plaque Index Gingival index(GI)-Loe&Sillness(1963) before and after dispensing of mouthwash.
Secondary Outcome Measures
Grams Staining of the plaque collected from the subjects
Supra-gingival plaque sample are taken microbiological(gram staining)analysis before and after mouthwash dispensing.
Full Information
NCT ID
NCT01956656
First Posted
September 17, 2013
Last Updated
December 10, 2013
Sponsor
Sri Hasanamba Dental College and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01956656
Brief Title
Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis
Official Title
Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis: A 4 Day Double Blind Clinico-Microbiological Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sri Hasanamba Dental College and Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
lotus leaf, mouthwash, gingivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lotus leaf mouthwash
Arm Type
Placebo Comparator
Arm Description
10 ml mouthwash to be used for 4days twice daily
Arm Title
placebo mouthwash
Arm Type
Placebo Comparator
Arm Description
10 ml mouthwash to be used for 4 days twice daily
Intervention Type
Drug
Intervention Name(s)
lotus leaf mouthwash
Other Intervention Name(s)
Lotus mouthwash
Intervention Description
Saline mouthwash to be used for 4 days twice daily by one group the other group the lotus leaf mouthwash
Primary Outcome Measure Information:
Title
Plaque induced gingivitis
Description
Gingivitis is measured using, Sillness&Loe(1964):Plaque Index Gingival index(GI)-Loe&Sillness(1963) before and after dispensing of mouthwash.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Grams Staining of the plaque collected from the subjects
Description
Supra-gingival plaque sample are taken microbiological(gram staining)analysis before and after mouthwash dispensing.
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Ravindra Shivamurthy, MDS
Organizational Affiliation
Sri Hasanamba Dental College and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sri Hasanamba Dental College and Hospital
City
Hassan
State/Province
Karnataka
ZIP/Postal Code
573202
Country
India
12. IPD Sharing Statement
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Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis
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