Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01956656
• Other study ID #: z59p5gy7
• Status: Unknown status
• Phase: N/A
• First received: September 17, 2013
• Last updated: December 10, 2013
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Sri Hasanamba Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• lotus leaf mouthwash
Saline mouthwash to be used for 4 days twice daily by one group the other group the lotus leaf mouthwash

Locations

Country	Name	City	State
India	Sri Hasanamba Dental College and Hospital	Hassan	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Sri Hasanamba Dental College and Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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