Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis

Not Applicable

• Conditions: Gingivitis
• Interventions: Drug: lotus leaf mouthwash

• Registration Number: NCT01956656
• Lead Sponsor: Sri Hasanamba Dental College and Hospital

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

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Subjects willing to comply with the study protocol & instruction.
2. Clinically diagnosed with chronic gingivitis.
3. No history of allergies to herbal formulations.
4. No history of periodontal therapy within the previous 6 months.
5. No history of antibiotic therapy within the previous 6 months.

Exclusion Criteria

1. Any systemic diseases
2. Use of tobacco or tobacco related products
3. Pregnant woman and lactating mothers
4. Subjects that had used any type of antibacterial mouthrinse within 4 weeks of recruitment in to the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lotus leaf mouthwash	lotus leaf mouthwash	10 ml mouthwash to be used for 4days twice daily

Primary Outcome Measures

Name	Time	Method
Plaque induced gingivitis	4 days	Gingivitis is measured using, Sillness\&Loe(1964):Plaque Index Gingival index(GI)-Loe\&Sillness(1963) before and after dispensing of mouthwash.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sri Hasanamba Dental College and Hospital; 🇮🇳 Hassan, Karnataka, India