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临床试验/CTRI/2024/07/070005
CTRI/2024/07/070005招募中2 期

A comparative 6 months evaluation of clinical and radiographic outcome of necrotic single rooted teeth obturated using two different bioceramic sealers : A CBCT-based randomized clinical study

Dr Riddhi Vasa1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
48
试验地点
1
主要终点
Healing of Periapical lesions is expected to be better than Cera seal bio-ceramic sealer in approximately 20 samples

研究概览

简要总结

The present study aims to compare the clinical and radiographic outcome of single rooted teeth obturated using hydraulic condensation technique with two different bio-ceramic sealer (Angelus Bio- C Sealer and Ceraseal Bio-ceramic Sealer) on a CBCT in patients with Periapical lesions having CBCTPAI score of 3 or above.

It will be a 6 month follow-up study.

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 Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria 1.Systemically healthy patients (Category: American Society of Anesthesiologists Class 2 or less than 2) 25 between 18 – 65 years of age.
  • 2.Maxillary or mandibular single rooted teeth diagnosed with Pulpal necrosis with symptomatic or asymptomatic apical periodontitis with lesions that show periapical radiolucency with (CBCTPAI) Score 323 will be included in the study.
  • 3.Re-treatment cases with periapical lesions with CBCTPAI Score 3 will be included in the study.
  • 4.A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.

排除标准

  • Exclusion criteria 1.Pregnant and lactating women will be excluded.
  • 2 Patients having teeth with poor prognosis, open apices, internal/external resorption, fractured Roots or visibly cracked tooth, grade 3 mobility, severe periodontal bone loss will be excluded from the study 3.Patients having teeth with complex root canal morphology such as Calcified canals, extreme curvatures or anomalies will be excluded from the study.

结局指标

主要结局

Healing of Periapical lesions is expected to be better than Cera seal bio-ceramic sealer in approximately 20 samples

时间窗: Healing of periapical lesions will be assessed at baseline and after 6 months.

次要结局

  • PERIAPICAL HEALING WILL BE ASSESED ON CBCT AT BASELINE AND AFTER 6 MONTHS(At baseline & after 6 months interval.)

研究者

发起方
Dr Riddhi Vasa
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Riddhi Vasa

K.M. Shah dental college and hospital

研究点 (1)

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