Outcome Following Use of Different Concentrations of Sodium Hypochlorite as Wound Lavage and Hemostatic Agent in Partial Pulpotomy: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Clinical success rate
研究概览
简要总结
The aim of this randomised control trial is to compare the effect of different concentrations of NaOCl on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
The main question it aims to answer are:
- clinical and radiographic outcome of partial pulpotomy following use of 5% and 3% NaOCl in mature permanent teeth with clinical signs indicative of irreversible pulpitis.
- OHRQoL and pain experience after use of 5% and 3% NaOCl during partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
详细描述
TITLE :- Outcome following use of different concentrations of NaOCl as wound lavage and hemostatic agent in partial pulpotomy: A Randomised control trial.
Question it aims to answer:
Does pulpal lavage using 3% and 5% sodium hypochlorite have comparable effect on outcome of partial pulpotomy in mature permanent teeth with clinical signs of irreversible pulpitis? P (Population) -Mature permanent mandibular molars with signs of irreversible pulpitis.
I (Intervention) - 5% NaOCl C (Comparison) - 3% NaOCl O (Outcome) - 1. Assessment of clinical and radiographic success at 12 months of follow up.
2. Assessment of OHRQoL and pain experience at baseline, post-operatively every 24 hours for 1 week and OHRQoL at 6 and 12 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The operator, patient and the outcome assessor will be masked to the group allocation
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mature permanent mandibular molars.
- •Teeth with clinical diagnosis of symptomatic irreversible pulpitis
- •Patients having normal periapical status with periapical index (PAI) score ≤ 2
- •Periodontally healthy teeth
- •Patients having physical status of class 1 or 2 according to ASA classification
- •Pulpal bleeding can be controlled within 6 minutes.
- •Presence of extremely deep carious lesion on radiograph -
排除标准
- •1) Non restorable teeth 2) Necrotic pulp evident upon exposure 3) Negative response to vitality test 4) Presence of sinus tract 5) Presence of soft tissue swelling 6) Radiographic signs of internal or external root resorption 7) Pregnant women
研究组 & 干预措施
Control: 3% sodium hypochlorite
After partial pulpotomy procedure, pulp wound will be irrigated with 3% sodium hypochlorite and haemostasis will be achieved by placing the cotton pellet soaked with 3% sodium hypochlorite on the amputated pulp.
干预措施: effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. (Procedure)
Test: 5% sodium hypochlorite
After partial pulpotomy procedure, pulp wound will be irrigated with 5% sodium hypochlorite and haemostasis will be achieved by placing the cotton pellet soaked with 5% sodium hypochlorite on the amputated pulp.
干预措施: effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. (Procedure)
结局指标
主要结局
Clinical success rate
时间窗: baseline to 12 months
Clinical criteria of success:- 1. No pain or discomfort except for the first few days after treatment. 2. No tenderness to palpation or percussion and the tooth is functional. 3. Normal mobility and probing pocket depth. 4. Healthy soft tissues around teeth with no swelling, sinus tract.
Radiographic success rate
时间窗: Baseline to 12 months
Radiographic success criteria:- 1. No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph. 2. Complete radiographic healing
次要结局
- Post Operative Pain(Baseline to 7 days)
- OHRQoL assessment(baseline and at 24 h, 2, 3, 4, 5, 6 and 7 days after the treatment, and then at 6 and 12 months.)