Histological evaluation of dental pulp response to Biodentine, enamel matrix derivative (Emdogain) and mineral trioxide aggregate (MTA) as direct pulp capping agents
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Inflammatory cell response
研究概览
简要总结
The goal of restorative therapy is not only to restore the tooth to proper form and function but also to preserve the pulp vitality. Direct pulp capping helps to seal the pulp against bacterial penetration, encourage the pulp to wall of the exposure by forming a dentine bridge and to maintain healthy pulp tissue. Emdogain serves as a biologically active pulp capping agent specifically inducing pulpal repair and hard tissue formation. Several case reports and clinical studies have evaluated the effect of Biodentine, Emdogain and MTA for pulp capping, but till now histologic studies have not been conducted and hence this study is planned.
Objectives of the study:
1. To evaluate histologically the response of dental pulp to Biodentine as direct pulp capping agent
2. To evaluate histologically the response of dental pulp to Enamel Matrix Derivative (Emdogain) as direct pulp capping agent
3. To evaluate histologically the response of dental pulp to Mineral Trioxide Aggregate (MTA) as direct pulp capping agent
4. To compare the above three
Participants:
Sample Size: 78 subjects
Sampling/Recruitment/Collection: Patients visiting the outpatient department of Conservative Dentistry and Endodontics, Dental College, RIMS, Imphal
Histologic outcome variables will be measured according to criteria given by Cox et al.
Inflammatory cell response:
Grade 1: Absent or very few inflammatory cells
Grade 2: Mild or average number < 10 inflammatory cells
Grade3: Severe inflammatory lesion appearing as an abscess or dense infiltrate involving one –third or more of the coronal pulp.
Grade 4: Completely necrotic pulp.
Dentine bridge formation:
Grade 1: Presence of a calcific bridge directly adjacent to some portion of the medicament interface.
Grade 2: Presence of a calcific bridge distant from the medicament interface.
Grade 3: No evidence of any calcific bridge formation in any sections.
Risks involved in the study: No risks and discomfort to the subjects since the teeth are already planned to be extracted for orthodontic/ periodontal treatment and the involved materials are approved by the regulatory authorities and used in routine clinical procedures.
Benefits of the study: In spite of a wide research made in the field of pulp physiology, there is no single gold standard regimen for Direct pulp capping that can achieve reliable and predictable goals of preserving tooth vitality. Preservation of pulp is extremely important to continue growth in root length and width in those teeth in which root formation has not yet been completed, to allow odontoblasts to create a dentine bridge between the pulp and the dressing material, and to maintain pulp function. The benefits of preserving tooth vitality is to maintain tooth function within the oral cavity which allows jaws to maintain a healthy level of bone.
Steps taken up to maintain confidentiality:
The data acquisition will be coded and not identified by name.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 25.00 Year(s)(—)
- 性别
- All
入选标准
- •Healthy patients in the age group of 14-25 2)Fully erupted permanent teeth (mandibular and maxillary planned for extraction due to periodontal involvement/ indicated for surgical extraction) 3)Minimum of 3 premolar teeth with closed apices scheduled for extraction for orthodontic treatment 4)Cases with vital mature teeth with symptomatic exposure of vital pulp tissue by caries or trauma and without radiographic evidence of periapical lesion.
排除标准
- •Pulpal involvement/ presence of periapical radiolucency 2)Spontaneous and nocturnal toothache 3)Tooth mobility 4)Developmental defects 5)No response to pulp sensibility tests 6)Uncontrollable hemorrhage at the time of exposure 7)Patients unwilling to participate 8)Immunocompromised patients.
结局指标
主要结局
Inflammatory cell response
时间窗: 6months
Dentin bridge formation
时间窗: 6months
次要结局
- Dentin bridge formation(6Months)
