Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars With Reversible Pulpitis: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 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 the study is to compare the clinical and radiographic outcomes of direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Primary objective of the study is to evaluate the clinical and radiographic success of direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Secondary objective of the study is to evaluate and compare postoperative pain following direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Subjects of age group 18 - 40 yrs will be included and divided into two groups 1) Permanent mature molars with deep carious lesion 2) Permanent mature molars with extremely deep carious lesion.
详细描述
TITLE-Comparative evaluation of direct pulp capping between deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. PICO P (Population) -Mature permanent mandibular molars with clinical signs of reversible pulpitis. I (Intervention) - Direct pulp capping in teeth with extremely deep carious lesion. C (Comparison) - Direct pulp capping in teeth with deep carious lesion. O (Outcome) - 1. Assessment of clinical success at 7 days, 6 months, 12 months and radiographic success at 6 and 12 months of follow up. To assess pain experience at preoperative and post operatively at 24 hours intervals for one week. Direct pulp capping is considered as the most conservative procedure to treat mechanically or traumatically exposed pulp. In this procedure, biomaterial is directly applied on the exposed pulp. According to depth of caries, carious lesion has been classified as deep caries (reaching inner quarter of dentine) and extremely deep caries (extending through entire dentine thickness). Various studies on direct pulp capping in deep carious lesions with reversible pulpitis have reported success rates ranging from 77.3% to 100%. A prospective study by demonstrated a 95.2% success rate for direct pulp capping with extremely deep carious lesions and reversible pulpitis in young individuals. A randomized clinical trial , which included both deep and extremely deep carious lesions, reported a direct pulp capping success rate of 81.3%. A recent systematic review and meta-analysis highlighted that the depth of caries penetration is a critical factor that need to be considered when evaluating the outcomes of direct pulp capping in cariously exposed pulps. Currently, there is a lack of clinical trials comparing the effectiveness of direct pulp capping in cases of deep and extremely deep caries presenting with reversible pulpitis. Hence, the present trial is designed to assess differences in clinical and radiographic outcomes of direct pulp capping between deep and extremely deep carious lesions in mature permanent teeth diagnosed with reversible pulpitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •The patient should be 18-40 years of age.
- •Patients with deep and extremely deep caries in permanent mandibular molars.
- •Deep caries lesion -Reaching the inner quarter of dentine on radiograph
- •Extremely deep caries lesion - Caries penetrating the entire thickness of dentin on radiograph.
- •Reversible pulpitis will be diagnosed clinically based on discomfort experienced by the participant when a stimulus such as cold or sweet is applied and goes away within a couple of seconds following removal of stimulus, with no significant radiographic changes in the periapical region of the suspect tooth and pain experienced is not spontaneous.
- •Tooth should give positive response to pulp sensibility testing.
- •Bleeding can be controlled with in 8 minutes.
- •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.
- •Internal/external resorption.
- •Patient experience spontaneous pain.
- •Negative response to vitality testing
- •No pulp exposure after complete caries excavation.
- •Signs of pulpal necrosis, insufficient bleeding after pulp exposure, sinus tract, swelling.
- •Bleeding could not be controlled in 8 minutes.
- •Pregnant women
- •Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency diseases , infectious diseases, kidney or liver, migraine)
研究组 & 干预措施
Direct pulp capping in extremely deep carious lesion
Direct pulp capping will be performed after establishing a clinical diagnosis of reversible pulpitis . If the tooth showed symptoms triggered by cold stimuli but relieved within couple of seconds.
干预措施: Direct pulp capping in extremely deep carious lesion. (Procedure)
Direct pulp capping in deep carious lesion
Direct pulp capping will be performed after establishing a clinical diagnosis of reversible pulpitis i.e. if the tooth showed symptoms triggered by cold stimuli but relieved within couple of seconds.
干预措施: Direct pulp capping in deep carious lesion. (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 (Periapical index score 1 or 2 ). 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)