Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis: A 4 Day Double Blind Clinico-Microbiological Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Plaque induced gingivitis
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects willing to comply with the study protocol & instruction.
- •Clinically diagnosed with chronic gingivitis.
- •No history of allergies to herbal formulations.
- •No history of periodontal therapy within the previous 6 months.
- •No history of antibiotic therapy within the previous 6 months.
排除标准
- •Any systemic diseases
- •Use of tobacco or tobacco related products
- •Pregnant woman and lactating mothers
- •Subjects that had used any type of antibacterial mouthrinse within 4 weeks of recruitment in to the study.
研究组 & 干预措施
lotus leaf mouthwash
10 ml mouthwash to be used for 4days twice daily
干预措施: lotus leaf mouthwash (Drug)
结局指标
主要结局
Plaque induced gingivitis
时间窗: 4 days
Gingivitis is measured using, Sillness\&Loe(1964):Plaque Index Gingival index(GI)-Loe\&Sillness(1963) before and after dispensing of mouthwash.
次要结局
- Grams Staining of the plaque collected from the subjects(4 days)
研究者
Dr.Gopi Kishore.C.R.
P.G. student
Sri Hasanamba Dental College and Hospital