Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Success rate at 12 months
研究概览
简要总结
The aim of this randomised control trial is to compare the effect of wound lavage using 2.5% Ca(OCl)₂ and 2.5% NaOCl on the outcome of partial pulpotomy in mature permanent mandibular molars with symptomatic irreversible pulpitis (SIP).Primary objective is to evaluate and compare clinical and radiographic outcome of partial pulpotomy following use of 2.5% Ca(OCl)₂ and 2.5% NaOCl in mature permanent mandibular molars with symptomatic irreversible pulpitis.secondary objective is to evaluate OHRQoL and pain experience after use of 2.5% Ca(OCl)₂ and 2.5% NaOCl during partial pulpotomy in permanent mandibular molars with clinical signs indicative of symptomatic irreversible pulpitis.
详细描述
The aim of this randomised control trial is to compare the effect of wound lavage using 2.5% Ca(OCl)₂ and 2.5% NaOCl on the outcome of partial pulpotomy in mature permanent mandibular molars with symptomatic irreversible pulpitis (SIP).
PICO P (Population) -Mature permanent mandibular molars with carious pulpal exposure and symptomatic irreversible pulpitis (SIP).
I (Intervention) - wound lavage using 2.5% Ca(OCl)₂ C (Comparison) - wound lavage using 2.5% NaOCl O (Outcome) -
- Assessment of clinical and radiographic success at 6 and 12 months of follow up.
- Assessment of OHRQoL and pain experience at baseline, post-operatively every 24 hours for 1 week and OHRQoL at 6 and 12 months.
In symptomatic irreversible pulpitis (SIP), bacterial invasion of pulp tissue is common, however the inflammation is usually confined to the area adjacent to the carious lesion. It has been suggested that removal of this affected pulp tissue segment and the surrounding infected dentin can help create an environment that promote pulpal healing.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18-40 years
- •Mature permanent mandibular molars with extremely deep caries (caries penetrating the entire thickness of the dentine radiographically, without radiopaque zone separating lesion from the pulp) and clinical diagnosis of SIP with PAI score ≤ 2
- •Periodontally healthy teeth (probing pocket depth ≤3 mm and mobility within normal limit)
- •Patients having physical status of class 1 or 2 according to ASA classification
- •Pulpal bleeding could be controlled within 10 min following pulp amputation
排除标准
- •Non restorable teeth
- •No pulp exposure even after complete caries excavation
- •Necrotic or partially necrotic pulp upon exposure
- •Presence of sinus tract or soft tissue swelling
- •Radiographic signs of internal or external root resorption
- •Pregnant women
研究组 & 干预措施
Partial pulpotomy using calcium hypochlorite as wound lavage agent
Partial pulpotomy will be performed using calcium hypochlorite as wound lavage agent ,after establishing a clinical diagnosis of symptomatic irreversible pulpitis i.e. if the tooth showed symptoms triggered and lingered by cold stimuli.
干预措施: Partial pulpotomy using calcium hypochlorite as wound lavage agent (Procedure)
Partial pulpotomy using sodium hypochlorite as wound lavage agent
Partial pulpotomy will be performed using sodium hypochlorite as wound lavage agent ,after establishing a clinical diagnosis of symptomatic irreversible pulpitis i.e. if the tooth showed symptoms triggered and lingered by cold stimuli.
干预措施: Partial pulpotomy using sodium hypochlorite as wound lavage agent (Procedure)
结局指标
主要结局
Success rate at 12 months
时间窗: 12 months
Criteria for success:- Clinical: 1. Absence of signs and symptoms of spontaneous pain or pain on stimulus and 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. Absence of associated soft tissue swelling, sinus or fistula. Radiographic: - 1. Absence of any periapical or interradicular radiolucency. 2. Complete radiographic healing (PAI score 1 or 2 acc. to Ostravik et al). 3. Absence of internal and external root resorption Tooth will be considered successful when all the above parameters are met.
次要结局
- Postoperative pain(Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment)
- OHRQoL assessment(Baseline and at 24 hours, Day1,Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment)