Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis

Study Overview
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Brief Summary
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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
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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

Official Title
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Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis: A 4 Day Double Blind Clinico-Microbiological Trial.

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: lotus leaf mouthwash


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: lotus leaf mouthwash<br>10 ml mouthwash to be used for 4days twice daily | Drug: lotus leaf mouthwash<br>* Saline mouthwash to be used for 4 days twice daily by one group the other group the lotus leaf mouthwash<br>* Other names: Lotus mouthwash;|
| Placebo Comparator: placebo mouthwash<br>10 ml mouthwash to be used for 4 days twice daily | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grams Staining of the plaque collected from the subjects | Supra-gingival plaque sample are taken microbiological(gram staining)analysis before and after mouthwash dispensing. | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lotus leaf, mouthwash, gingivitis