A Comparative Clinical and Radiographic Study of Collagen Based Pulpotomy Versus Biodentine Pulpotomy in Children With Cariously Exposed Vital Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 40
- 主要终点
- absence of internal root resorption
研究概览
简要总结
Pulpotomy of vital primary molars is indicated when caries removal results in pulp exposure. Treatment approaches consist of devitalization using formocresol, preservation using ferric sulfate and regeneration of the remaining pulp tissue using mineral trioxide aggregate and recently Biodentine have been utilized.
The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promoting the healing of the root pulp and be compatible with the physiological process of root resorption.
Searching for more pulpotomy agents, Collagen, a protein that's present abundantly in humans, is an important component of connective tissues and performs multiple functions including wound healing.
Enamel and dentin contain Collagen as one of the components in their organic ground matrix.
Collagen has been used widely in dentistry in periodontal and implant therapy as scaffold for preventing the migration of epithelial cells and encouraging wound repopulation by cells with high regenerative potential.
The Collagen available for dental implication is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contamination. The collagen particles
详细描述
Pulpotomy is considered the gold standard procedure for treating cariously exposed pulps in asymptomatic primary teeth. Which is based on the healing ability of the radicular pulp tissue following amputation of the infected coronal pulp.
Mineral trioxide aggregate (MTA) has been recommended as the gold standard for vital pulp therapy; however, it has some disadvantages, such as long setting time, poor handling properties, high cost, and the potential for tooth discoloration. Biodentine (Septodont, Saint-Maur-des-Fossés, France), one of the new-generation, bioactive endodontic cements, has been claimed to have improved properties over MTA.
Biodentine presents high biocompatibility with the dental pulp, it has high antibacterial effects and antifungal activity, has a shorter setting time than MTA as a result of the calcium chloride in the liquid component of Biodentine. It also has higher flexural strength, compressive strength and modulus of elasticity than MTA.
Consequently, Biodentine can be used as a pulp dressing as well as a base material.
Quest is on for newer pulpal medicaments that are biocompatible and capable of healing the dental pulp by producing reparative dentin and/or dentinal bridge in response to various stimuli and surgical exposure.
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
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Children:
- •Aged 4 to 7, in good general health and medically free.
- •Cooperative patients who will comply to follow ups.
- •Parents provided with written informed consent. • Teeth:
- •Bilaterally Carious vital primary molars with reversible pulpitis.
- •Restorable teeth with no more than 1/3 of root resorption.
排除标准
- •• Children:
- •Children with medical, physical, or mental conditions.
- •Unable to attend follow up visits. • Teeth:
- •Primary molars with any congenital anomalies.
- •Previously accessed teeth.
- •At operative procedure, haemorrhage control is unachievable after pulpotomy.
研究组 & 干预措施
(Experimental group) collagen based Pulpotomy
(sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India)
干预措施: sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India (Drug)
(Control group) Biodentine pulpotomy
Biodentine (Septodont, Saint-Maur-des-Fossés, France)
干预措施: Biodentine (Septodont, Saint-Maur-des-Fossés, France) (Drug)
结局指标
主要结局
absence of internal root resorption
时间窗: 12 months
radiographic measurement of internal root resorption
次要结局
- absence of pain and swelling(12 months)
研究者
Nihal Alaa Eldin Mohamed Mostafa Bayoumi
principal investigator
Cairo University