COMPARATIVE EVALUATION OF DIRECT PULP CAPPING AND COMPLETE PULPOTOMY IN MATURE PERMANENT MANDIBULAR MOLARS WITH CLINICAL SIGNS INDICATIVE OF MODERATE PULPITIS: RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Clinical and radiographic success
研究概览
简要总结
Title: Comparative evaluation of direct pulp capping and complete pulpotomy in mature permanent mandibular molars with clinical signs indicative of moderate pulpitis: Randomized Clinical Trial
Rationale: According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which are correspond to irreversible pulpitis.
Complete/partial pulpotomy are suggested to be the choice of treatment for such cases. It has been suggested that infection is often the cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Based on this premise, DPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of partial/complete pulpotomy in adults
Research Question Does Direct Pulp Capping have comparable outcome with complete pulpotomy in mature permanent teeth with clinical signs indicative of moderate pulpitis?
详细描述
Rationale: Vital pulp therapy has been traditionally recommended only in teeth with reversible pulpitis with no periapical pathologies or in teeth with either mechanical pulp exposure or recent traumatic exposure. Clinical symptoms such as characteristic, severity and intensity of pre-operative pain do not accurately talk about the status of the pulp inflammation and the depth of involvement. It has been demonstrated that there is no precise correlation between clinical symptoms and the histopathological status of the pulp, mainly in case of irreversible pulpitis, that might lead to a wrong diagnosis. Vitality tests such as cold test or electric pulp tests reveal only whether the pulp is responsive to respective stimuli or not. According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which are correspond to irreversible pulpitis.
Complete/partial pulpotomy are suggested to be the choice of treatment for such cases. It has been suggested that infection is often the cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Based on this premise, DPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of partial/complete pulpotomy in adults
Aim: To compare the outcome of direct pulp capping and complete pulpotomy in mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
Objectives:
- To evaluate the clinical and radiographic success of direct pulp capping in mature permanent molars with clinical signs indicative of moderate pulpitis.
- To evaluate the clinical and radiographic success of complete pulpotomy in mature permanent molars with clinical signs indicative of moderate pulpitis.
- To evaluate pain incidence and severity after direct pulp capping and complete pulpotomy in mature permanent molars with clinical signs indicative of moderate pulpitis
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（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 1 st 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
- •Teeth with immature roots.
- •No pulp exposure after caries excavation.
- •Bleeding could not be controlled in 6 minutes.
- •Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.
- •History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.
- •Internal/external resorption.
- •Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine) -
结局指标
主要结局
Clinical and radiographic success
时间窗: 12 months
Clinical success criteria 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 No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic6 et al.
次要结局
- Pain incidence and reduction(7 days)