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临床试验/CTRI/2024/03/064767
CTRI/2024/03/064767尚未招募2 期

Efficacy of Erbium: Yttrium Aluminium Garnet and Diode laser in enhancing the tissue regeneration ability and clinical outcome in regenerative endodontics

Dr Biji Brigit1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
63
试验地点
1
主要终点
Resolution of symptoms

研究概览

简要总结

The study is designed to assess the success of revascularization in mature teeth with periradicular lesion and the effect of laser in enhancing the regenerative ability.

The experimental groups are

Group 1: Regenerative endodontic procedure (REP) procedure similar to American Association of Endodontists clinical considerations (2016) for immature teeth

Group 2: Diode Laser

Group 3: Er: YAG laser

A power analysis was established by G*power, version 3.0.1(Franz Faul universitat, Kiel, Germany). A sample size of 51 (17 per group) would yield 90% power to detect significant differences, with assuming the effect size of 0.2, (Eldessoky et al) and significance level at 0.05. Considering 20% attrition rate, total sample size is 51+12= 63 (21 per group)

Group 1 the standard revascularization procedure will be carried out as per the AAE guidelines which includes triple antibiotic paste in first appointment for disinfection followed by revaculrization and pRF placement in second appointment which is after 14 days.

in group 2 and group 3 laser assisted irrigation will be used for disinfection and triple antibiotic paste will not be used. during the revascualrization visit photobiomodulation with the respective laser will be done.

patients will be recalled at 1month, 3 months, 6 months, 12 months and 24 months for clinical assessment of symptoms, pulp sensibility tests, digital radiographic assessmnt. CBCT will be done at 12 month follow up to evaluate the regression of periapical lesion.

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 50.00 Year(s)(—)
性别
All

入选标准

  • Adult male or female subjects 18–50 years of age with Single rooted mature teeth with single canals with Negative response to pulp sensibility test and Peri apical index (PAI) score-3 or 4.

排除标准

  • Teeth with periodontal disease, cracks, and minimal coronal structure, Subjects with systemic disease, Pregnant and lactating females.

结局指标

主要结局

Resolution of symptoms

时间窗: Assessment of symptoms at 1 month, 3 months, 6 months, 12 months and 24 month intervals

次要结局

  • The resolution of periapical lesion size & positive response to pulp sensibility tests.(Pulp sensibility tests & digital radiographs at 1 month, 3 months, 6 months, 12 months & 24 month intervals. CBCT at 12 month recall visit.)

研究者

发起方
Dr Biji Brigit
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Biji Brigit

Government Dental College and Research Institute

研究点 (1)

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