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临床试验/CTRI/2025/03/081947
CTRI/2025/03/081947尚未招募3 期

Comparative Evaluation of Regenerative endodontic procedure and conventional non-surgical endodontic procedure for treatment of necrosed mature permanent teeth with apical periodontitis - A Randomized Control Trial

Dr. Ashlesha Madankar1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年3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
58
试验地点
1
主要终点
Reduction in Periapical Index Score radiographically

研究概览

简要总结

Pulp regeneration continues to receive increasing
research attention. Regenerative endodontic procedures (REPs) have been
associated with revascularization procedures originally proposed more than 50
years ago. Effective
sealing at both the apical and coronal ends of a disinfected root canal
system are the essential requisites of a successful root canal treatment.
Gutta-percha along with a sealer has been the material of choice for
obturating the root canals. The periapex contains a variety of progenitor
cells which may participate in the regeneration of tissues as a response to
injury. Thus, regeneration rather than replacement of tissues with an
artificial substitute is the alternative direction in which endodontics is
progressing. Biodentine
was developed as a new class of dental material, introduced in 2010 by Gilles
and Olivier which could conciliate high mechanical properties with excellent
biocompatibility, as well as a bioactive behavior. Biodentine is a new
tricalcium silicate (Ca3SiO5) based inorganic restorative commercial cement
and advertised as ‘bioactive dentine substitute’. The material is claimed to
possess better physical and biological properties compared to other
tricalcium silicate cements such as mineral trioxide aggregate (MTA) and
Bioaggregate(Bioaggregate).  It is used
for crown and root dentin repair treatment, repair of perforations or
resorptions, apexification, root-end fillings and as permanent dentine
substitute in large carious lesions.

   Thus, this study compares the non-obturating regenerative endodontic procedure using biodentine and modified triple antibiotic paste with conventional non-surgical gutta percha obturation procedure for the treatment of necrosed mature permanent teeth with apical periodontitis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients with Permanent single rooted teeth with complete root formation are included.
  • Permanent single rooted teeth with diagnosis of mature necrosed teeth with symptomatic apical periodontitis and Permanent single rooted teeth indicated for primary root canal treatment with Periapical Index Score (PAI) of equal to or more than 3 are included.

排除标准

  • Patients who are medically compromised are excluded.Patients who had taken antibiotics in last 1 month and Pregnant and lactating women are excluded.Immature teeth or teeth with root resorption and Teeth with calcified canals and Patients with generalized chronic periodontitis and Teeth with previous root canal treatment and Teeth with canal curvature more than 25 degree and Periodontal pocket larger than 3 mm are excluded.

结局指标

主要结局

Reduction in Periapical Index Score radiographically

时间窗: 1,3,6 and 12 months

次要结局

  • CLINICAL EVALUATION (Presence of vitality, swelling, sinus tract with spontaneous, palpation or percussion pain)(1,3,6 and 12 months)

研究者

发起方
Dr. Ashlesha Madankar
申办方类型
Other [self sponsored]
责任方
Principal Investigator
主要研究者

Dr Ashlesha Nageshwar Madankar

Government Dental College and Hospital, Nagpur

研究点 (1)

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