Viewing Study NCT01956656



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Last Modification Date: 2024-10-26 @ 11:13 AM
Study NCT ID: NCT01956656
Status: UNKNOWN
Last Update Posted: 2013-12-11
First Post: 2013-09-17

Brief Title: Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis
Sponsor: Sri Hasanamba Dental College and Hospital
Organization: Sri Hasanamba Dental College and Hospital

Study Overview

Official Title: Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis A 4 Day Double Blind Clinico-Microbiological Trial
Status: UNKNOWN
Status Verified Date: 2013-12
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 indexwill 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None