Establishing a Direct Pulp Capping Protocol Using Biodentine in Mature Permanent Teeth With Reversible Pulpitis: A Prospective Case Series
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Overall treatment success
研究概览
简要总结
This study evaluates the clinical and radiographic outcomes of direct pulp capping using Biodentine (Septodont, Saint-Maur-des-Fossés, France), a calcium silicate-based cement, in mature permanent teeth diagnosed with reversible pulpitis following carious or mechanical pulp exposure. Biodentine was placed as a full-thickness (bulk) capping and interim restoration, with a definitive composite restoration completed at a later visit. Pulp vitality, postoperative pain, and radiographic healing are assessed over a 6-month follow-up period.
详细描述
Mature permanent teeth clinically diagnosed with reversible pulpitis and presenting vital pulp exposure (carious or mechanical) were treated with direct pulp capping. After caries removal under rubber dam isolation, haemostasis of the exposed pulp was achieved with 2.5% sodium hypochlorite. Biodentine (Septodont, Saint-Maur-des-Fossés, France), a calcium silicate-based cement, was then placed as a full-thickness (bulk) direct pulp capping material, filling the cavity and serving as an interim restoration. At a subsequent visit (approximately 2 to 6 weeks later), the superficial layer of Biodentine was reduced and a definitive composite restoration was placed. Participants were followed clinically and radiographically at 1 week, 1 month, 3 months, and 6 months to assess pulp vitality, symptoms, and periapical status, including dentin bridge formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mature permanent teeth clinically diagnosed with reversible pulpitis
- •Vital pulp exposure (carious or mechanical) confirmed intra-operatively
- •Positive response to pulp sensibility testing (cold and/or electric pulp test) at baseline
- •Successful haemostasis of the exposed pulp achieved within 6 minutes
- •Patient consent to follow-up
排除标准
- •Irreversible pulpitis or pulp necrosis
- •Spontaneous or lingering pain
- •Radiographic periapical pathology
- •Haemostasis not achieved within the time limit
- •Non-restorable teeth
- •Teeth with periodontal compromise
研究组 & 干预措施
Direct pulp capping with Biodentine
All participants received direct pulp capping with Biodentine placed as a full-thickness (bulk) capping and interim restoration, followed by a definitive composite restoration at a subsequent visit.
干预措施: Direct pulp capping with Biodentine (Procedure)
结局指标
主要结局
Overall treatment success
时间窗: 3 months, and 6 months
Number of teeth with overall treatment success, defined as meeting both clinical and radiographic success criteria simultaneously. Clinical success: no spontaneous or lingering pain, negative percussion test, normal peri-radicular soft tissue (no swelling or sinus tract), positive response to pulp sensibility testing (transient cold response and electric pulp test within normal limits), and no abnormal tooth discoloration. Radiographic success: normal peri-radicular structures with continuous lamina dura and non-widened periodontal ligament space, no new periapical radiolucency, no internal or external root resorption, and stable pulp chamber and canal morphology. Reported as the number of teeth meeting the success criteria.
次要结局
- Postoperative pain intensity(24 hours, day 2-7, week 2-4, 3 months, and 6 months)
- Pulp vitality (sensibility response)(Baseline, 1 month, 3 months, and 6 months)
研究者
Le Thi My Linh
DDS, MSc candidate
University of Medicine and Pharmacy at Ho Chi Minh City