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临床试验/CTRI/2022/02/040683
CTRI/2022/02/040683尚未招募2 期

Histological evaluation of dental pulp response to Biodentine, enamel matrix derivative (Emdogain) and mineral trioxide aggregate (MTA) as direct pulp capping agents

未提供1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2022年1月3日最近更新:

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)

研究者

发起方
未提供

研究点 (1)

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