Clinical Trial: Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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


Sponsor: Sri Hasanamba Dental College and Hospital

Current Primary Outcome: Plaque induced gingivitis [ Time Frame: 4 days ]

Gingivitis is measured using, Sillness&Loe(1964):Plaque Index Gingival index(GI)-Loe&Sillness(1963) before and after dispensing of mouthwash.


Original Primary Outcome: Same as current

Current Secondary Outcome: Grams Staining of the plaque collected from the subjects [ Time Frame: 4 days ]

Supra-gingival plaque sample are taken microbiological(gram staining)analysis before and after mouthwash dispensing.


Original Secondary Outcome: Same as current

Information By: Sri Hasanamba Dental College and Hospital

Dates:
Date Received: September 17, 2013
Date Started: September 2013
Date Completion: December 2013
Last Updated: December 10, 2013
Last Verified: December 2013