Effects of Total and Selective Caries Removal - Requiring or Avoiding Vital Pulp Therapy - on Pulp Vitality and Postoperative Pain in Deep Carious Mature Permanent Teeth: A Split-Mouth Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- pulp survival at twelve months
研究概览
简要总结
The effect of selective caries cleaning and total caries cleaning on pulp health and post operative pain in teeth with deep caries will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and outcome assessors were blinded to the intervention groups. The operator was not blinded due to the visible differences between total and selective caries removal techniques.
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥15 years with bilateral deep carious mature permanent teeth.
- •Positive vitality test (cold sensitivity).
- •No spontaneous pain or periapical radiolucency.
- •Willingness to attend 6- and 12-month follow-ups
排除标准
- •Uncontrolled systemic diseases Pregnancy or allergy to dental materials used Teeth with irreversible pulpitis (spontaneous pain, necrosis) Non-restorable teeth (fractures, extensive decay)
研究组 & 干预措施
Arm 2
Partial caries excavation
干预措施: Selective Caries Removal (Procedure)
Arm 1
Complete caries excavation
干预措施: Total Caries Removal (Procedure)
结局指标
主要结局
pulp survival at twelve months
时间窗: twelve months
The pulp is expected to remain vital, with no percussion tenderness and no spontaneous pain
Early postoperative pain intensity (VAS) after total vs. selective excavation
时间窗: first week
The patient will be asked to rate his/her pain on day 1, 3 and 7 according to VAS
pulp survival at twelve months
时间窗: twelve months
The pulp is expected to remain vital, with no percussion tenderness and no spontaneous pain
Early postoperative pain intensity (VAS) after total vs. selective excavation
时间窗: first week
The patient will be asked to rate his/her pain on day 1, 3 and 7 according to VAS
dentin bridge formation
时间窗: twelve months
no dentin bridge formation is expected in selective caries cleaning, while dentin bridge formation will be observed radiologically in total cleaning
次要结局
未报告次要终点
研究者
Zehra SUSGUN YILDIRIM
Principal Investigator
Cukurova University