This trial is active, not recruiting.

Condition gingivitis
Treatment lotus leaf mouthwash
Sponsor Sri Hasanamba Dental College and Hospital
Start date September 2013
End date December 2013
Trial size 30 participants
Trial identifier NCT01956656, z59p5gy7


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Placebo Comparator)
10 ml mouthwash to be used for 4days twice daily
lotus leaf mouthwash Lotus mouthwash
Saline mouthwash to be used for 4 days twice daily by one group the other group the lotus leaf mouthwash
(Placebo Comparator)
10 ml mouthwash to be used for 4 days twice daily

Primary Outcomes

Plaque induced gingivitis
time frame: 4 days

Secondary Outcomes

Grams Staining of the plaque collected from the subjects
time frame: 4 days

Eligibility Criteria

Male or female participants from 18 years up to 25 years old.

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.

Additional Information

Official title Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis: A 4 Day Double Blind Clinico-Microbiological Trial.
Principal investigator Dr Ravindra Shivamurthy, MDS
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Sri Hasanamba Dental College and Hospital.