Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis

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.

Study Overview

• Status: Unknown
• Conditions: Gingivitis
• Intervention / Treatment: Drug: lotus leaf mouthwash

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Hassan, Karnataka, India, 573202
      • Sri Hasanamba Dental College and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: lotus leaf mouthwash; 10 ml mouthwash to be used for 4days twice daily	Drug: lotus leaf mouthwash; Saline mouthwash to be used for 4 days twice daily by one group the other group the lotus leaf mouthwash; Other Names: Lotus mouthwash
PLACEBO_COMPARATOR: placebo mouthwash; 10 ml mouthwash to be used for 4 days twice daily

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sri Hasanamba Dental College and Hospital
• Investigators: Principal Investigator: Dr Ravindra Shivamurthy, MDS, Sri Hasanamba Dental College and Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (ESTIMATE): October 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: lotus leaf, mouthwash, gingivitis
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: z59p5gy7