Dental Pulp Response to The Combination Use of Platelet-Rich Fibrin and Mineral Trioxide Aggregate in Partial Pulpotomy of Sound Human Premolars: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Appearance of dentin bridge
研究概览
简要总结
The aim of this study is to evaluate the clinical and histological pulp responses when MTA and a combined of MTA/PRF is used as pulp-capping agents after partial pulpotomy.
详细描述
Partial pulpotomy is generally considered as the treatment of choice for immature permanent teeth with reversible injury. Mineral trioxide aggregate (MTA) is a gold standard material as pulp capping agent in term of vital pulp therapy. Despite many advantages, MTA has a long setting time, little biological inductivity, difficult handling characteristics and high cost.
An essential aspect of tooth tissue engineering is the identification of a suitable scaffold to support cell growth and tissue regeneration. Platelet-Rich Fibrin (PRF) is a second generation platelet concentrate. It is strictly autologous and helps to release the growth factors necessary for the regeneration of dentin pulp complex. Therefore, PRF seems to be a suitable scaffold in vital pulp therapy.
Study sample, 24 intact maxillary or mandibular premolars which will be extracted for orthodontic reasons in 12 healthy volunteers. The sample will be chosen from the patients who are coming to the Orthodontic department in the Faculty of dentistry - Damascus university.
This study will be performed as split mouth study. For each selected patient, one premolar will be randomly allocated to MTA only and the other to combined MTA/PRF by a toss of coin. The main operator will give each patient a numerical code (from 1 to 12) whilst the teeth will have an alphabetical coding (e.g. For the patient coded as 1, premolar with MTA will be coded as 1-a, the other premolar with MTA/PRF will be coded as 1-b). In all patient documents, the teeth will be labeled in the same way so that the clinical examiner and a pathologist will be blinded to the capping technique used for each tooth whilst the main operator who perform a pulpotomy will know which technique is used for each premolar.
Postoperative pain and sensitivity to thermal stimuli will be analyzed after the treatment between two sides.
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
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No systemic disease and no medication consumption.
- •Participants, with healthy first premolars in either of the jaws, assigned for orthodontic extraction (scheduled extraction of the maxillary/mandibular premolars).
- •The premolar teeth needed to be fully erupted.
- •The premolar teeth needed to respond within the normal range to cold testing and heat testing.
- •The patients' parents had read, signed and thoroughly understood the informed consent.
排除标准
- •Presence of systematic disease and medication consumption of any type.
- •Anti-inflammatory medicine taken before and during the time of study.
- •Premolars with caries, restoration or any abnormality on periapical radiographs.
- •If the premolar teeth were not fully erupted.
- •If the premolar teeth revealed a lingering pain (a pain sensation that had the tendency to linger as a dull ache after the stimulus had been removed upon cold testing and heat testing).
结局指标
主要结局
Appearance of dentin bridge
时间窗: eight weeks after intervention
This outcome will be evaluated by means of light microscopy linked to the camera with magnification of 4X, 20X, 40X and 100X. Each histologic section will be scored from 1-4, with 1 representing the most desired result and 4 representing the least desired result as follows: 1. Dentin that displays a tubular structure or dentin associated with irregular hard tissue that is not exhibit the characteristic tubular structure, but resemble bony tissue and often display cellular inclusions. 2. Only irregular hard tissue deposition. 3. Only a thin layer of hard tissue deposition. 4. No hard tissue deposition
Thickness of dentin bridge
时间窗: eight weeks after intervention
This outcome will be evaluated by means of light microscopy linked to the camera with magnification of 4X, 20X, 40X and 100X. A periodontal probe will be placed over a histologic section to serve as a scale before image acquisition. The thickness of dentin bridge will be measured at the thickest, thinnest, and midmost point areas of the bridge. The average of the 3 values will be calculated. Each histologic section will be scored from 1-4, with 1 representing the most desired result and 4 representing the least desired result as follows: 1. Thickness of dentin bridge is more than 0.25mm 2. Thickness of dentin bridge is less than 0.25mm but more than 0.1mm. 3. Thickness of dentin bridge is less than 0.1mm 4. Partial or absent bridge.
Intensity of Pulp Inflammation
时间窗: eight weeks after intervention
This outcome will be evaluated by means of light microscopy linked to the camera with magnification of 4X, 20X, 40X and 100X. Each histologic section will be scored from 1-4, with 1 representing the most desired result and 4 representing the least desired result as follows: 1. Absent or very few inflammatory cells 2. Mild: defined as an average of inflammatory cells is less than 10 cells. 3. Moderate: defined as an average of inflammatory cells is more than10 cells but less than 25 cells. 4. Severe: defined as an average of inflammatory cells is more than 25 cells.
Extension of Pulp Inflammation
时间窗: eight weeks after intervention
This outcome will be evaluated by means of light microscopy linked to the camera with magnification of 4X, 20X, 40X and 100X. Each histologic section will be scored from 1-4, with 1 representing the most desired result and 4 representing the least desired result as follows: 1. Absent 2. Mild: defined as inflammatory cells only next to pulp exposure site 3. Moderate: defined as inflammatory cells observed in part of coronal pulp (in one-third or more of the coronal pulp or in the middle pulp) 4. Severe: defined as all coronal pulp is infiltrated
次要结局
- Postoperative pain: VAS(using a 0 to 10-cm visual analog scale (VAS) scale, pain will be record every 24 hours until the seventh day after intervention)
- Sensitivity to thermal stimuli(this outcome will be examined every week until the eighth week after intervention)