Efficacy of Kshara Taila in Plaque induced Gingivitis A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in Bleeding on probing score (BOP), expressed in percentage.
研究概览
简要总结
Plaque-induced gingivitis is generally regarded as a site-specific inflammatory condition initiated by dental biofilm accumulation and characterized by gingival redness and edema and the absence of periodontal attachment loss. The disease is commonly painless, rarely leads to spontaneous bleeding, and is often characterized by subtle clinical changes detectable only by trained personnels. Consequently, most patients are either unaware of it or unable to recognize it. Recent reports suggest that it is found in 46.6% of the adult Indian population.
The standard treatment of gingivitis is the use of antiseptic mouthwash containing chlorhexidine. Despite its wide use, chlorhexidine is recognised as a corrosive, irritant, health hazard and environmental hazard by the Globally Harmonized System of Classification and Labelling of Chemicals. Chlorhexidine has known common side effects such as increased plaque, peeling of oral mucosa, dry mouth, tongue discolouration, teeth sensitivity, altered taste perception, short bursts of burning sensation, and teeth staining. More recent reviews concluded that the result of kavala / oil-pulling is comparable to that of chlorhexidine, without showing any side effects. But the oils tested in these studies— coconut oil, gingelly oil, olive oil etc.—were randomly chosen based on anecdotes, not based on an existing guideline from any traditional medicines.
The closest correlation of plaque-induced gingivitis in Ayurveda is dantasharkara which is described as a firm accumulation of mala on teeth. Caused by the lack of dental hygiene leading to the shoshana of kapha by vata, dantasharkara deteriorates the normal properties of teeth and presents with halitosis. Since spontaneous bleeding is not specified in this condition, the clinical picture here is that of stage 2 or 3 gingivitis. Dantasharkara is managed by lekhana (scraping) and kshara taila avasechana (oil-pulling). Lekhana karma for dantasharkara has not been standardised yet and the effect of kshara taila oil-pulling in plaque-induced gingivitis remains to be studied. Hence the current study intends to evaluate the efficacy of kshara taila oil-pulling in plaque-induced gingivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •An anticipated ability to attend the scheduled visits 2) Having plaque-induced gingivitis (ICD-10-CM Diagnosis Code K05.10).
排除标准
- •Participants contra-indicated for gandusha or kavalagraha 2) Less than 20 natural teeth 3) Participants who are pregnant or nursing.
- •A dental student or faculty or dental staff member.
- •Usage of fixed or removable orthodontic appliance 6) Clinical loss of periodontal ligament / attachment 7) Recent history of (within two weeks prior to examination), or ongoing, antibiotic therapy.
- •A need for immediate antimicrobial treatment for periodontitis.
- •Continuing use of anticoagulant medications 10) Dry mouth syndrome or significant food allergies.
- •Any dental procedures or oral prophylaxis within 15 days prior to examination 12) Presence of an intraoral soft tissue pathology 13) Smoking 14) Any significant medical condition that contributes to the development of dental plaque (like diabetes, cardiovascular diseases, autoimmune conditions etc) 15) Presence of major physical or mental limitation or restriction that prohibit the hygiene procedures used in the study protocol 16) Any other condition which in the opinion of the investigators places the participant at risk if they were to participate in the study.
结局指标
主要结局
Improvement in Bleeding on probing score (BOP), expressed in percentage.
时间窗: 8 days after treatment and 16 days after treatment
次要结局
- 1) Modified Gingival Index(2) Modified Plaque Score)
研究者
Vishnu Govind M
The CVM University