Comparative evaluation of the Efficacy of mouthrinse containing 0.1% Hyaluronic Acid and 0.2% Chlorhexidine gluconate and mouthrinse containing 0.2% Chlorhexidine gluconate alone in plaque induced gingivitis patients with fixed orthodontic appliance: A Clinico- biochemical study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Reduction in plaque score and gingival index score ( gingival inflammation)
研究概览
简要总结
In the oral cavity, plaque forms biofilm over the tooth surface, that harbors numerous microorganism. The role of dental plaque at the interfaces of tooth and gingiva causes gingival inflammation, which could eventually lead to periodontitis.
Orthodontics brackets are one of the plaque retentive factor which leads to gingivitis. Therapy for gingivitis is mainly directed at minimizing the etiologic factors to eliminate inflammation, thus allowing gingival tissues to heal. It can be managed with an effective plaque control program and debridement of tooth surfaces coupled with continued periodontal maintenance procedures to prevent re-initiation of inflammation.
Chlorhexidine is one of the most effective topical antiseptics reported so far that has been used successfully for treating gingivitis and remains as gold standard for all chemical antiplaque agents.
This study aims to assess the clinical and biochemical parameters to determine the efficacy of mouthrinse containing hyaluronic acid and Chlorhexidine gluconate in controlling plaque induced gingivitis in patients with fixed orthodontic appliance.
HA has shown anti- inflammatory, anti-bacterial, and antioxidant effects in the treatment of periodontal diseases. Because of its biocompatibility and non-toxicity, the use of exogenous HA-based biomaterials, topically on to inflamed periodontal sites would provide beneficial effects in accelerating and modulating the host response
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- 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
- •Participants with full-mouth fixed orthodontic appliance with plaque-induced gingivitis Participants between age group of 18 years and above.
- •Presence of at least 24 natural teeth in the mouth excluding the third molars Mild/moderate/severe gingivitis ( GI score by Loe & Silness 0.1-3.0) Probing depth not more than 3 mm.
排除标准
- •Physical or mental handicap.
- •Syndromic / systemic diseases contributing to inflammatory process.
- •Participants who had taken antibiotic therapy in the month prior to the commencement of the study.
- •Participants with known allergy to chlorhexidine or Hyaluronic acid.
- •Participants currently using mouthwashes Smoking Pregnant and lactating women.
- •Active caries.
- •Participants on anticoagulants.
结局指标
主要结局
Reduction in plaque score and gingival index score ( gingival inflammation)
时间窗: Assessed at baseline , 15 th day and at 1 month
次要结局
- Changes in inflammatory biomarker levels in both the groups(Assessed at baseline and at 1 month from baseline)
研究者
JOHNVEE S
Yenepoya Dental College