The Effect of Sodium Hypochlorite and Chlorhexidine as Cavity Disinfectants on the Post Operative Pain and Success of Partial Caries Removal in Deep Carious Lesion With Moderate Pulpitis in Permanent Teeth: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Clinical success criteria
研究概览
简要总结
To investigate The Effect of Sodium hypochlorite and Chlorhexidine as cavity Disinfectants on the post operative pain and Success of Partial Caries Removal in deep carious lesion with moderate pulpitis in permanent teeth
详细描述
Study Design: Intervention Research Question : To investigate whether the use of 2% chlorhexidine and 5.25% sodium hypochlorite can improve the clinical and radiographic outcome after partial caries removal in deep carious lesion P (Population) - Mature Permanent Mandibular molars with deep carious lesion involving inner two third of dentine I (Intervention) - - Partial caries removal using 2% chlorhexidine/5.25% sodium hypochlorite as cavity disinfectant..
C (Comparison) - Partial caries removal using saline as cavity disinfectant. O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.
-To assess incidence and reduction in pain post operatively at every 24 hours till 1 week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient should be ≥18 years of age.
- •Restorable mature permanent 1st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement)
- •Tooth should give positive response to pulp sensibility testing.
- •Clinical diagnosis of moderate pulpitis.
- •Radiographic finding of periapical index (PAI) score ≤
- •Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit)
排除标准
- •Presence of vertical root fracture Presence of root perforations ASA-3 or ASA-4 according to the classification of the American Society of Anesthesiologists) Presence of root resorption Combined endodontic-periodontic lesions. Pregnancy
研究组 & 干预措施
Pt receiving SCR followed by disinfection with Chlorhexidine
The cavity was disinfected with 2% CHX.
干预措施: Selective caries removal with CHX (Procedure)
Pt receiving SCR treatment
No disinfectant solution was applied (control group).
干预措施: Selective caries removal (Procedure)
Pt receiving SCR followed by disinfection with NaOCl
the cavity was disinfected with 2.5% sodium hypochlorite
干预措施: Selective caries removal (Procedure)
Pt receiving SCR followed by disinfection with NaOCl
the cavity was disinfected with 2.5% sodium hypochlorite
干预措施: Selective caries removal with NaOCl (Procedure)
Pt receiving SCR followed by disinfection with Chlorhexidine
The cavity was disinfected with 2% CHX.
干预措施: Selective caries removal (Procedure)
结局指标
主要结局
Clinical success criteria
时间窗: 12 months
No history of spontaneous pain or discomfort except for the initial days after treatment. No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.
Radiographic success criteria
时间窗: 12mnths
No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to OrstavicKet al.
次要结局
- Pain assesment(7 days)