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临床试验/CTRI/2025/01/079476
CTRI/2025/01/079476尚未招募3 期

To compare the efficacy of new light cure MTA with existing bioceramics in management of exposed dental pulp tissue: A randomized control clinical trial

Dr Srinivasa T S1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Primary outcome will be clinical and radiographic success rates at the 1,3, 6 and 12 months follow up

研究概览

简要总结

Direct exposure of the pulp to the oral environment breaks the integrity of the pulp-dentin complex, if not treated properly, will lead to apical periodontitis, which eventually requires root canal treatment or extraction. The treatment widely practiced for exposed dental pulp is considered root canal treatment as healing of the pulp tissue is unpredictable. Direct pulp capping has been described as a method that utilizes regenerative capacity of human dental pulp cells. The procedure of pulp capping relies primarily on the ability of pulpal tissue to heal and its ability to form hard tissue barriers called reparative dentin. Pulp capping material should provide a suitable condition to encourage regeneration of the dentin-pulp complex which will induce differentiation of odontoblast like cells, be antibacterial, biocompatible, and nontoxic.

Calcium hydroxide introduced in 1930 by Herman was considered gold standard for the treatment of direct pulp exposure by reparative dentine formation and strong antibacterial property. Drawbacks such as high solubility, low mechanical resistance and lack of bond to dentine often lead to tunnel defect formation with use of calcium hydroxide. [2] Many formulations have been proposed to overcome the drawback of calcium hydroxide such as resin infiltrate glass ionomer, calcium phosphate, bio-silicates material such as MTA and Biodentine, light cure tricalcium silicate cement.

Biodentine have high mechanical properties, excellent biocompatibility and bioactive behavior. Due to its good sealing ability with dentin, it is used as a dentin replacement material as pulp protection, temporary restoration, cervical filling, direct and pulp capping and pulpotomy.

Currently MTA introduced by Torabinejad in 1990 has gain popularity as a material of choice for direct pulp capping. The success rates of direct pulp capping were reported to range from 67.4% at 3 years and 97.96% after a 9-year follow-up for MTA.MTA elevates the expression of transcription factors, induces dentin bridge formation, possesses biocompatibility and sustains a high pH for a longer duration and a close physiochemical seal with dentin that forms an insoluble barrier to prevent microleakage.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • 1 Tooth with deep caries 2 Permanent 1st and 2nd molar 3 Carious exposure 0.5mm to 2mm 4 Tooth with diagnosis of reversible pulpitis 5 Positive pulp response.

排除标准

  • 1 Presence of crowns, removable partial dentures, 2 Patient with history of orthodontic treatment, 3 Patient with open bite malocclusion 4 Primary teeth 5 Teeth with irreversible pulpitis/ pulp necrosis/ presence of periapical lesion 6 Tooth with periodontal disease, calcified canal, internal or external resorption 7 Pulpal bleeding that could not be controlled within 10 minutes 8 Patient with tumor(s) of the soft or hard tissues of the oral cavity 9 Any developmental disorders 10.Congenital defect of tooth,.

结局指标

主要结局

Primary outcome will be clinical and radiographic success rates at the 1,3, 6 and 12 months follow up

时间窗: 1,3, 6, 12 months

次要结局

  • postoperative pain(7 days)

研究者

发起方
Dr Srinivasa T S
申办方类型
Other [SELF FUNDED]
责任方
Principal Investigator
主要研究者

Dr SRINIVASA T S

ALL INDIA INSTITUTE OF MEDICAL SCIENCESGORAKHPUR

研究点 (1)

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