Effectiveness of a polyherbal formulation to treat gingivitis over a period of three months: A randomized trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- reduction in gingivitis and halitosis over a period of three months
研究概览
简要总结
Commonoral health problems like gingivitis, halitosis and dentinal hypersensitivityaffect all people irrespective of age, gender and race. These conditions inparticular affect the quality of life of the individual almost on a dailybasis. In south India, studies report a prevalence of gingivitis to be 57%, and 47% from halitosis respectively. A plethoraof treatment options are available to alleviate these conditions ranging fromprofessional intervention to home care solutions, but individuals by majorityopt for home care remedies. The principal home care remedy for the treatment ofsuch common oral problems is dentifrice.
Medicateddentifrice containing chemicals such as triclosan or chlorhexidine is the goldstandard for treating gingivitis and halitosis. They have their own merits butalso causes tooth staining, taste alterations and rare instances mucosaldesquamation and microbial resistance owing to prolonged use. Further, not muchhas been explored regarding a suitable herbal alternative towards the treatmentof dentinal hypersensitivity.
Recentfocus has shifted to the anti-inflammatory and antimicrobial properties ofnatural products, because of the widespread microbial resistance as aconsequence of drug overuse. Several plants with herbal properties wereidentified through literature search and used through centuries by ourforefathers to treat several oral conditions. The principal ingredientsincluded in the phytotheraputic paste contain Terminalia chebula, Phylathus embelica, Terminalia belerica,Glycyrrhiza glabra, Acmella oleracea, Salvadora perscia, Ficus benghalensisamong others.
Weintend to check the effectiveness of a poly herbal paste formualtion with the aforementioned components to treat conditionssuch as gingivitis and halitosis.
Aim: to evaluate the effectiveness of a polyherbal formulation to treat gingivitis and halitosis over a period of three months: A randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from moderate to severe gingivitis and malodor of oral origin.
- •Those providing consent to participate and willing to be available for followup for 3 months.
排除标准
- •Systemic diseases, oral malodor from extra oral origin and those allergic to any constituents of toothpaste are excluded.
- •Those not willing to provide consent and not available for followup for three months are excluded.
结局指标
主要结局
reduction in gingivitis and halitosis over a period of three months
时间窗: 30, 60, 90 days
次要结局
- reduction in plaque microbial load, total salivary bacterial load and total protein content(30, 60 and 90 days)