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临床试验/CTRI/2012/11/003102
CTRI/2012/11/003102招募中不适用

A randomized equivalence clinical trial to evaluate the efficacy of an innovative, non-obturation endodontic treatment protocol “SealBio†for mature, permanent non-vital teeth as compared to conventional endodontic treatment with root canal obturation

Indian Council of Medical Research ICMR1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2012年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
192
试验地点
1
主要终点
Complete control and resolution of clinical signs

研究概览

简要总结

To evaluate and compare the healing response following novel, non-obturation endodontic treatment and the conventional endodontic treatment protocol by clinical and radiographic evaluation with pre and post treatment digital intra-oral X-ray and Cone Beam Computed Tomography (CBCT).xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

192 cases of at least 2 periapically infected teeth will be included in the study (Sample calculation shown in Materials and methods). Ethical clearance and informed consent of the patient will be taken.  Inclusion and exclusion criteria will be laid down and followed. One of the affected teeth will be treated by conventional endodontic procedure of cleaning, shaping, disinfection, obturation and coronal seal. The other tooth will be treated by the novel treatment protocol. Pretreatment digital intraoral periapical X rays and CBCT will be taken. The cases will be followed up at 3, 6 months, 1, 1 ½ and 2 years and evaluated clinically and radiographically. Post treatment CBCT will be taken only at 6-months interval. The data will be analyzed and healing response will be compared in the two groups.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Open Label

入排标准

年龄范围
10.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • •Cases presenting with clinical or radiographic signs and symptoms of periapical pathologies, irrespective of age and sex will be included in the study.

排除标准

  • •Patients having any systemic disease, which can compromise the healing response such as diabetes, patients on excessive medications, on immuno-suppressants, those receiving RT or CT etc.
  • •will not be included.

结局指标

主要结局

Complete control and resolution of clinical signs

时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years

and symptoms of periapical disease, such as

时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years

pain, swelling, inflammation and restoration of

时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years

function

时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years

Radiographic evidence of healing of periapical

时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years

lesions showing disappearance or reduction in

时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years

size of the lesion or atleast arrest of lesion size

时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years

(not increasing)

时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years

次要结局

  • Formation of a natural, biological seal of(mineralized tissue at the root apices)

研究者

发起方
Indian Council of Medical Research ICMR
申办方类型
Government funding agency

研究点 (1)

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