Outcome of Direct Pulp Capping Compared to Partial Pulpotomy in the Management of Carious Pulp Exposures in Mature Teeth: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Short term clinical outcome
研究概览
简要总结
This a prospective randomized clinical trial that compare vital pulp therapy procedures in permanent teeth with carious pulp exposure. Patients are recruited from the dental teaching clinics at JUST following preset inclusion criteria. They are subsequently randomly assigned to one of treatment procedures. Clinical and radiographic follow up is performed after 6 months and yearly up to 5 years.
详细描述
Background: Deep carious lesions are commonly encountered in both adults and children with no clear consensus on the ideal clinical management. Vital pulp therapy including direct pulp capping and pulpotomy is increasingly considered in the management of carious pulp exposures when the clinical diagnosis is reversible pulpitis with variable reports of success rates with different materials used and different diagnostic categories.
Aims: The aims of this study are to evaluate the clinical and radiographic outcomes of direct pulp capping and partial pulpotomy in deep carious lesions of mature permanent teeth using a calcium silicate based material (Biodentine, Septodont, France), and to investigate the relationship between matrix metalloproteinase (MMP 9) levels in the pulpal blood and the outcome of these procedures.
Methods: 120 mature molar teeth in 120 patients with deep carious lesions exposing the pulps on the radiograph and with symptoms of reversible pulpitis will be included in the study. The teeth will be subsequently randomly divided into 2 groups (n=60). One group will receive direct pulp capping and composite restoration, and the second group will receive partial pulpotomy and composite restoration. Pulpal blood will be collected from the exposure site and will be tested for the level of MMP9 using special ElISA kit. Preoperative and postoperative pain level at 48 hours and 7 days will be evaluated on a scale from 0-10.
The treated teeth will be further evaluated clinically and radiographically at 6 and 12 months follow up and yearly afterward. The relationship of the outcome to the level of MMP9 will be investigated. The results will be statistically analyzed using appropriate tests in the SPSS software.
Expected results: Since partial pulpotomy includes the removal of 2-3 mm of the exposed pulp tissue which is theoretically inflamed, it is expected to be more effective in alleviating the patient's symptoms and to have a higher success rate than simply pulp capping the carious exposure. High levels of MMP9 are also expected to have a correlation with the failure rate.
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)
盲法说明
the participants are blinded to the type of treatment provided, the care provider is masked only during the early stages of teh procedure but subsequently masking is not possible due to different treatment protocols.
Block randomization. and sealed envelop technique are used. Principal investigator and evaluator are blinded to the type of treatment provided
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non -contributory medical history (ASA 1)
- •Molar tooth with extremely deep caries extending>2/3 of dentin or exposing the pulp on the periapical radiograph
- •The tooth should give positive response to cold testing
- •Clinical diagnosis of reversible pulpitis with mild to moderate symptoms
- •The tooth is restorable, probing pocket depth and mobility are within normal limits
- •No signs of pulpal necrosis including sinus tract or swelling
- •No radiographic evidence of periapical changes indicative of apical periodontitis
排除标准
- •Immature teeth
- •Nonvital teeth
- •Irreversible pulpitis and periapical periodontitis, i.e spontaneous and lingering pain.
- •Inability to achieve hemostasis after 6 minutes of application of 5% NaOCl moist pellet
- •No pulp exposure after nonselective caries removal
研究组 & 干预措施
Direct pulp capping
After caries excavation and pulp exposure, the cavity is disinfected . the capping material is applied and the tooth is restored.
干预措施: Direct pulp capping and partial pulpotomy (Procedure)
Partial pulpotomy
After caries excavation and pulp exposure, 2-3 mm of the exposed pulp are cut . The capping material is applied and the tooth is restored.
干预措施: Direct pulp capping and partial pulpotomy (Procedure)
结局指标
主要结局
Short term clinical outcome
时间窗: one week
Resolution of clinical symptoms
次要结局
- long term outcome(1-5 years)
研究者
Nessrin Taha
Professor
King Abdullah University Hospital