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临床试验/CTRI/2024/12/077911
CTRI/2024/12/077911尚未招募不适用

Effect of different sealers on post operative pain and peri apical healing in apical periodontitis cases: An in-vivo study

ITS Dental College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To evaluate and compare the effect of Bioceramic, Resin based and MTA based sealers on post operative pain and peri apical healing.

研究概览

简要总结

Apical periodontitis is characterized by localized inflammation of periapical tissues resulting from pulp disease, with potential causes including the progression of dental caries, trauma, or operative dental procedures.

Postoperative pain is a significant clinical outcome influenced by various treatment-related factors. These include maintaining the working length to the apical constriction, the duration and technique of endodontic treatment (whether completed in a single or multiple visits), and the type of endodontic sealer used for obturation.

Periapical healing involves the intricate interplay between osteoclasts and osteoblasts, resulting in the structural and functional replacement of bone. This process is influenced by both intrinsic and extrinsic mechanisms of the host. A local factor affecting the healing of periapical tissues is the root canal sealer, which can interfere with the process by leaching through the apical foramen and lateral canals.

The study will be done to evaluate and compare the effect of Bioceramic, Resin based and MTA based sealers on post operative pain and peri apical healing. The forthcoming clinical study will be carried out within the Department of Conservative Dentistry and Endodontics at I.T.S. Dental College, Hospital, and Research Centre in Greater Noida,Uttar Pradesh.  A total number of 30 patients will be selected from the O.P.D of Department of Conservative Dentistry and Endodontics according to inclusion and exclusion criteria. Inclusion criteria: single rooted tooth, Patient with asymptomatic/symptomatic apical periodontitis with periapical radiolucency more than 2mm, Age 18-60 years. Exclusion criteria: Multi rooted tooth, Re RCT cases,Patients on Immunosuppresive drugs/systemic diseases, Inability to reach full working length/ calcified canals, Tooth with draining sinus, Multi rooted tooth,Re RCT cases,Patients on Immunosuppresive drugs/systemic diseases, Inability to reach full working length/ calcified canals, Tooth with draining sinus. The selected patients will be further divided into 3 groups: Group 1: AH plus(Dentsply), Group 2: Bio C(Angelus), Group 3: MTA Plus(Prevest). After biomechanical preparation, the canals will be dried using sterile paper points according to corresponding taper and freshly mixed calcium hydroxide paste will be placed into the prepared canals using a lentulospiral. The patients will be recalled after a week and patients who will be asymptomatic exhibiting a VAS Score of 0, will be obturated. Assessment postoperative pain will be done at an interval of 24 hrs, 48 hrs, 72 hrs,7 days, at rest and while biting, using the VAS scale. The number of analgesic pills that had been taken by the patient at each follow-up period, and will be recorded on patient’s chart. Assessment of peri apical healing will be done at an interval of 1 month, 3 months and 6 months, with help of intra oral radiograph.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Single rooted tooth Patient with asymptomatic/symptomatic apical periodontitis with periapical radiolucency more than 2mm Age 18-60 years.

排除标准

  • Multi rooted tooth Re RCT cases Patients on Immunosuppresive drugs/systemic diseases Inability to reach full working length/ calcified canals Tooth with draining sinus.

结局指标

主要结局

To evaluate and compare the effect of Bioceramic, Resin based and MTA based sealers on post operative pain and peri apical healing.

时间窗: at baseline

次要结局

  • to find out the best endodontic sealer to be used in case of apical periodontists for fast healing of periapical lesion & minimum post operative pain(at the end of the study duration which is 3 months & 3months follow up period)

研究者

发起方
ITS Dental College Hospital and Research Centre
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Kirtika Muktawat

I.T.S. DENTAL COLLEGE, GREATER NOIDA

研究点 (1)

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