Randomized Blind Clinical Trial, Two-armed, Parallel of Indirect Pulp Capping With Biodentine and TheraCal LC in Permanent Mature Molars With Deep Carious Lesions
试验速览
- 阶段
- 不适用
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- response to pulp sensibility testing ( thermal and electric pulp testing)
研究概览
简要总结
Management of deep carious lesions in permanent mature molars with reversible pulpitis represents a challenge for clinicians. Vital pulp therapy includes indirect and direct pulp capping, partial pulpotomy and full pulpotomy. Indirect pulp capping is a procedure in which a material is placed on a thin layer of remaining soft dentin that, if removed, might expose the pulp. The objective is dentin bridge formation and pulp vitality preservation.
The aim of this randomized clinical trial is to evaluate the success rate of indirect pulp capping with Biodentine and TheraCal LC in mature permanent molars with deep carious lesions at one-year follow-up examination. The null hypothesis tested will be that there is no statistically significant difference in success rate between both materials in indirect pulp capping of permanent mature molars with deep carious lesions.
详细描述
Treatment options for permanent mature molars with deep carious lesions and a preoperative diagnosis of reversible pulpitis are varied among clinicians. In the last few years, a more biological approach is arising interest in the field of Endodontics through the development of calcium-silicate based cements that are used in vital pulp therapy.
A great variety of materials have been employed for indirect pulp capping. Although calcium hydroxide has been the "gold standard" for decades for this procedure, nowadays calcium-silicate based cements such as Mineral Trioxide Aggregate (MTA) are preferred. The second generation of these cements, among which Biodentine (Septodont, Saint Maur-des-Fossés, France) and TheraCal LC (Bisco, Schaumburg, IL, USA) stand out, try to overcome the first generation limitations.
On the other hand, there is a paradigm shift in caries removal techniques. Nowadays, the non-selective technique is not longer recommended and a selective removal technique until soft dentin is preferred in deep cavitated lesions.
The study will be carried out at the dental clinic of the Master of Restorative Dentistry and Endodontics (Medical and Dental School) of University of Valencia (Spain).
The study protocol that will be followed is:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years without any systemic disease.
- •Presence of a deep carious lesion in a permanent mature molar without periapical pathology that penetrates radiographically into the inner dentin half or even third/ quarter.
- •Preoperative diagnosis of reversible pulpitis.
- •After selective caries removal to soft dentin with a high-speed diamond bur and Cariosolv gel and hand instruments, no pulpal exposure occurred.
排除标准
- •Negative response to pulp sensibility tests.
- •Clinical symptoms of irreversible pulpitis or pulp necrosis.
- •Presence of fistula, swelling, tenderness to percussion, tooth mobility.
- •Presence of periapical pathology on periapical radiographs (internal or external root resorption, abscence of normal appearance of periodontal ligament, presence of interradicular or periapical radiolucencies).
- •Pregnant women.
研究组 & 干预措施
Biodentine
Indirect pulp capping with Biodentine in mature permanent molars with deep carious lesions and reversible pulpitis
干预措施: Indirect pulp capping (Drug)
TheraCal LC
Indirect pulp capping with TheraCal LC in mature permanent molars with deep carious lesions and reversible pulpitis
干预措施: Indirect pulp capping (Drug)
结局指标
主要结局
response to pulp sensibility testing ( thermal and electric pulp testing)
时间窗: one year
abscence of clinical signs and/or symptoms and radiographic findings of pulp degeneration
次要结局
未报告次要终点
研究者
Cristina Pasarín Linares
Teaching Assistant
University of Valencia