Effectiveness of Herbal and 0.12% Chlorhexidine mouthwash on Gingivitis and Salivary Neutrophils Count.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Gingivitis - measured by Modified Loe and Silness Gingival index
研究概览
简要总结
Background and Aim: Use of mouthwashes as an adjunct in the daily oralhygiene regimen has been strongly recommended by the dentists worldwide.Chlorhexidine has in fact been proven to be a gold standard in mouthwashes andis known to significantly reduce/prevent gingivitis. But owing to itsside-effects of tooth discoloration and transient taste alteration on its longterm use, there has been a constant effort to discover an equally efficientmouthwash with minimal or no side-effects. The aim of this study was toevaluate the effectiveness of a commercially available herbal mouthwash(Himalaya HiOra Regular) in comparison to 0.12% Chlorhexidine mouthwash inreducing gingivitis and salivary neutrophil count.
Methods and Materials: This study was a double blinded, randomized design.The herbal mouthwash (Himalaya HiOra Regular) was compared to 0.12%Chlorhexidine mouthwash (positive control).The patients gingival health statuswas evaluated using Gingival Index and Salivary Neutrophil Count (usingFluorescent Microscope) at baseline visit, 15th day and 30thday of intervention.
Results: Outof the 36 subjects randomized, none were lost to follow up and a total of 18 were analysed in Group A(Himalaya HiOraRegular Mouthwash) and 18 in Group B(0.12% Chlorhexidine). Both the groupsshowed a statistically significant reduction in Gingival Index Score ( Group A - 17% & Group B - 14% ) and in Salivary Neutrophil Counts (GroupA - 35% & Group B -32%). There was no significant difference inbetween the two groups both in the Gingival Scores ( ) and in the salivaryneutrophil counts ( ).
Conclusions: Thisstudy has shown that herbal mouthwash is at par with the gold standard in reducing gingivitis in a 4 week period.Thus herbal mouthwash forms a promising adjunct to the daily oral hygieneregimen with minimal/ no side effects reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- All
入选标准
- •1.A minimum of 20 sound natural teeth with scorable facial and lingual surfaces.
- •2.Willingness to read, understand and sign the informed consent form.
- •3.Male and female subjects between 18-50 years in good general health.
- •4.Subject with good periodontal health with pockets < 6mm.
- •5.A gingival index score of ≥1.
- •6.A plaque index score of ≥1.
- •7.Availability for the entire study duration.
排除标准
- •1.Destructive periodontal disease.
- •2.Significant soft tissue pathology, systemically related gingival enlargement / severe gingivitis.
- •3.History of diabetes, hepatic, renal disease or other serious medical condition and transmissible disease.
- •4.Orthodontic appliance or any kind of fixed or removable appliances.
- •Materials & Methods 5.History of allergies to dental products or their ingredients.
- •6.Pregnant and breast feeding women.
- •7.History of adverse habits like smoking and tobacco chewing.
- •8.Undergoing antibiotic, steroid therapy or any anti-inflammatory drugs in the preceding month.
结局指标
主要结局
Gingivitis - measured by Modified Loe and Silness Gingival index
时间窗: 15th day and 30th day post intervention
次要结局
- Salivary Neutrophil Count(15th day and 30th day post intervention)