Clinical, Radiographical, and Histological Evaluation of Treatment Outcomes Following Different Caries Removal Strategies in Mature Permanent Teeth With Reversible Pulpitis (A Randomized Clinical Trial and Ex-vivo Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 主要终点
- clinical evaluation ………. Radiographic evaluation:
研究概览
简要总结
This clinical trial will be conducted to clinical, radiographical and histological evaluation of pulp condition with reversible pulpities after total and selective removal of primary and secondary caries (randomized clinical trial and exo-vivo study)
详细描述
Randomized clinical trial Sample size 144 case…
Randomization method used:
Sample size calculation was performed using R statistical analysis software version 4.3.2 for Windows
Outcome variables:
Pulp vitality and post operative pain Grouping classified into four groups as follows: The first group : total caries removal of primary caries(PTCR) 27 The second group: selective caries removal of primary caries(PSCR) The third group: total caries removal of secondary caries(STCR) The fourth group : selecive caries removal of secondary caries(SSCR)
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient's age from 18 years to 40 years old
- •Non -contributory medical history (ASA1)
- •Mature permanent posterior teeth with primary or secondary deep caries extending ≥ 2/3 of dentin
- •The tooth should give a positive response to cold testing
- •Clinical diagnosis of reversible pulpitis
- •The tooth is restorable via direct restoration, 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
- •Systemic medical conditions, pregnancy, alcoholic and smoker patients. 2- Teeth with spontaneous pain or percussion sensitivity in periodontal lesions, external or internal root resorption, sinus opening, mobility, or abscessed tooth. 3- Radiographic evidence of widened periodontal space, broken or interrupted lamina dura, and periapical radiolucency. 4- Intensified erosion damage or periodontitis. Patient reported clenching or bruxism, hopeless or non-restorable teeth. Immature teeth. 5- Patients with physical disabilities preventing tooth brushing. Patient had removable partial denture abutments, dental abscesses, pulp lesions, atypical facial pain, or pulpitis. 6- Patients had non-carious lesions like abrasion, erosion, attrition, or abfraction.
- •7- Patients with history of antibiotic or analgesics intake within few days of operative intervention. 8- Patients with previously root canal-treated teeth. 9- Periodontally compromised teeth. 10-Teeth that will be extracted for periodontal or orthodontic reasons as it will conduct for histological evaluation
结局指标
主要结局
clinical evaluation ………. Radiographic evaluation:
时间窗: 1year
clinical evaluation: absence of pain , pulp vitality, ………. Radiographic evaluation: absence of any periapical lesion or recurrent caries
clinical evaluation ………. Radiographic evaluation:
时间窗: 1year
clinical evaluation: absence of pain , pulp vitality, ………. Radiographic evaluation: absence of any periapical lesion or recurrent caries
次要结局
- histological evaluation and follow up(1 year)
研究者
Abeer mohamed shehata
Abeer Mohamed Shehata
Minia University