Comparison of Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Post operative pain
研究概览
简要总结
In the included patients, after complete removal of caries from the entire cavity, the exposed pulp will be treated with either a 2.5% NaOCl or 0.1% Octenidine solution. Subsequently, the cavity will be restored using calcium silicate cement, glass ionomer cement, and composite resin. Postoperatively, the patient's pain level will be assessed using the Visual Analogue Scale (VAS) at 24 and 72 hours, as well as on the 7th day. Responses to pulp sensitivity tests and periapical radiographs will be evaluated at 6 months.
详细描述
After obtaining a detailed pain history from the patients and conducting clinical and radiographic examinations, if a case is deemed suitable for the study, patients will be informed about the possibility of participating in this research project and the procedures involved. The risks and benefits associated with the study will be explained to the patients. Once a patient is considered a potential candidate for the study and expresses interest in participation, informed consent will be obtained.
Before the caries removal procedure, local anesthesia will be administered, and the teeth will be isolated using a rubber dam. Cavities will be prepared using a diamond bur under continuous water cooling. Caries will be completely removed from the entire cavity with the help of steel round burs and excavators, continuing until hard dentin is reached. Bleeding from the exposed pulp will be controlled by pressing a cotton pellet soaked in sterile physiological saline onto the exposure site for one minute. At this point, a researcher not involved in this study will provide the treating clinician with a glass dish containing either a 2.5% NaOCl or 0.1% Octenidine solution. A cotton pellet soaked in the test or control solution will be applied to the exposed pulp, and the cavity will be gently wiped. The cavity will be restored using calcium silicate cement, glass ionomer cement, and composite resin. Postoperatively, the patient's pain levels will be assessed using the Visual Analogue Scale (VAS) at 24 and 72 hours, as well as on the 7th day. Pulp sensitivity tests and periapical radiographs will be conducted at 6 months to evaluate the outcome.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic posterior tooth (premolar or molar) with deep caries
- •A healthy periodontal status, normal probing depth, and restorable.
- •Negative responses to percussion and palpation tests while responding positively to cold testing and electric pulp testing
排除标准
- •Participants will be excluded if they had any systemic diseases
- •A negative response to cold testing and electric pulp testing.
- •Presence of a sinus tract, absence of pulp exposure following complete caries removal, or necrotic or partially necrotic pulp tissue
研究组 & 干预措施
Octenidine
A cotton pellet soaked in 0.1% Octenidine will be applied to the exposed pulp area
干预措施: pulp lavage Octenidine (Other)
NaOCl
A cotton pellet soaked in 2.5% NaOCl will be applied to the exposed pulp area
干预措施: pulp lavage NaOCl (Other)
结局指标
主要结局
Post operative pain
时间窗: 72 hours
Use of the Visual Analog Scale (VAS) following the procedure
Post operative pain
时间窗: 24 hours
Use of the Visual Analog Scale (VAS) following the procedure
Post operative pain
时间窗: 48 hours
Use of the Visual Analog Scale (VAS) following the procedure
次要结局
- Pulp vitality-ct(6 months)
- Pulp vitality-ept(6 months)
- Pulp vitality-pr(6 months)
研究者
cemre koç
Dr.
Aydin Adnan Menderes University