Clinical Comparison of Octanidine and Chlorhexidine based Mouth rinses as an adjunct in post-periodontal flap Surgery Healing- A randomized controlled clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. To evaluate wound healing outcomes following the use of .1 % Octanidine mouthwash post-periodontal flap surgery on days 3, 7, and 14 utilizing the wound healing index,
研究概览
简要总结
Maintenance of high levels of oral hygiene plays a crucial role in success of any oral surgical procedure (1). Reduction of biofilm formation, prevention of infective complications on wound site and wound stability are very important for early wound healing (2). Reduction or elimination of oral biofilms is necessary to restore gingival tissues to a healthy state especially after a surgical procedure (3). However, mechanical means are often inadequate in ensuring plaque control and preventing infection at surgical sites (2,3). So, chemical agents can be used along with mechanical plaque control methods to ensure early wound healing (2).
Chlorhexidine is a widely used chemical antiplaque agent routinely prescribed to patients after common oral surgical procedures (1)(3)(4). It is a cationic bisbiguanide and has broad spectrum antimicrobial activity against gram positive bacteria, gram negative bacteria, yeast, viruses leading to chlorhexidine being a gold standard for oral biofilm prevention (3)(4).
When Chlorhexidine mouthwash is taken over a prolonged period of time, it causes tooth discoloration, mucosal irritation, cytotoxicity, and taste alteration. Octenidine dihydrochloride (OCT), cationic surfactant molecule with antibacterial properties. It binds to negatively charged microbial surfaces and adheres tenaciously to lipid components, which breaks the cell membrane of yeast, bacteria, and fungi.
There are reports of its drawback, including its unpleasant bitter taste; nonetheless, many manufacturers address this issue by adding flavourings before introducing it to the market.. With fewer reported adverse effects of octenidine hydrochloride, it may be used for a longer time than chlorhexidine.
Therefore, this study aims to compare the efficacy of two mouthwashes— .1% Octanidine and .12% Chlorhexidine based mouthwashes as an adjunctive post periodontal flap surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •(1) Patient who are indicated for periodontal flap surgery (2) Systemically healthy older than 18 years (3) With basic communication, reading and writing skills (4) Willingness to sign an informed consent form.
排除标准
- •(1) Surgeries other than periodontal flap surgery (2) Systematic diseases and psychological or medical disorders that might influence pain threshold (5) acute intraoral pain (periodontal or endodontic pain) (6) Hypersensitivity to the mouthwash ingredients.
结局指标
主要结局
1. To evaluate wound healing outcomes following the use of .1 % Octanidine mouthwash post-periodontal flap surgery on days 3, 7, and 14 utilizing the wound healing index,
时间窗: 3, 7, 14 days
2. To evaluate wound healing outcomes following the use of .12% chlorhexidine mouthwash post-periodontal flap surgery on days 3, 7, and 14 days using wound healing index.
时间窗: 3, 7, 14 days
3 To conduct both intergroup and intragroup comparisons of the outcomes.
时间窗: 3, 7, 14 days
次要结局
- To evaluate the PROM (patient reported outcome measures) among both the groups using Visual analogue scale and analgesic intake
研究者
Dr David K
manipal college of dental sciences ,mangalore