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临床试验/CTRI/2024/02/062822
CTRI/2024/02/062822尚未招募4 期

Effect of different apical preparation sizes and taper on outcome of primary orthograde endodontic treatment assessed using CBCT - a randomized clinical trial

Dr Kaadhambari S1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年2月24日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
1.Reduction in size of the periapical lesion after root canal treatment with the different apical preparation sizes and taper

研究概览

简要总结

After confirming the eligibility , the patients will be informed about the study design, the clinical procedure involved, and the associated risks.They will be  ensured that root canal treatment will be performed regardless of whether they decided to participate in the study or not. Once the patient agreed to participate, verbal and written consent will be obtained, and the patient will be randomly assigned to 1 of the 4 designated groups. Randomization will be developed to eliminate any bias on the part of the investigators and to balance the number of patients between the treatment protocol types.The clinical and CBCT findings will be verified before the Root Canal Treatment.

Clinical Procedure

After the administration of local anesthesia (Lignocaine HCl with 2% adrenaline 1:80,000 (Lignox 2% A,Indoco Warren) caries will be excavated, and the access cavity will be  prepared under rubber dam isolation. The working length will be determined with the help of an electronic apex locator (Coltene Whaledent Private LTD) and will be confirmed with straight and angled radiographs. Then canals will be prepared using the step-back technique with 0.02% taper ISO stainless steel hand files.The apical preparation will be done with No.25,0.04% ; No.25,0.06% ; No.30,0.04% ; No.30,0.06% rotary files ( Hyflex CM) in groups A,B,C,D respectively and it will be accompanied by irrigation with 5 mL of  5.25% NaOCl (Prime Dental product Private Ltd, INDIA)  after each instrumentation cycle. Canal patency will be  ensured by passing a #10 stainless steel file approximately 0.5 to 1.0 mm beyond the working length. After enlarging, the canals will be  irrigated with 5 mL  of 17% EDTA for 1 minute. After drying with sterile absorbent points, the canals will be  filled with paste made by mixing calcium hydroxide powder  with 2% chlorhexidine liquid  using a lentulo spiral. The tooth will  then temporarily restored with Intermediate Restorative Material (Prime Dental product Private Ltd, INDIA).  The patient will be recalled after 1 week. At the next appointment, the paste will be removed with the help of XP Endo Finisher and copious irrigation with 5.25% NaOCl followed by a final rinse of 5.0 mL 17% EDTA. If the patient is asympomatic then the canals be obturated with gutta-percha and bioceramic sealer(CERASEAL, MetaBiomed,Europe) using lateral condensation technique, if the patient is symptomatic the canals will be cleaned and shaped and the intracanal medicament will be placed again and patient will be recalled again after 1 week . After obturation, the access cavity will be  restored. An immediate postoperative radiograph will be taken using preset exposure parameters and will be processed manually. Follow-up examinations will be performed after 6  months and it consists of history taking and clinical and CBCT examination.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • 1.Those who are able to provide informed consent 2.Mature permanent teeth 3.Carious mandibular molars with asymptomatic apical periodontitis 4.Radiographic evidence of periapical lesion in mesial root of mandibular first molars.

排除标准

  • 1.Allergies to local anaesthetics or sulphites.
  • 2.Below the age of 18 years.
  • 3.History of significant medical conditions.
  • 4.Teeth with cracks,fractures,endo perio lesion, periapical abscess,furcation involvement.
  • 5.Teeth with more than two canals in mesial root of mandibular molars.
  • 6.Pregnant women.

结局指标

主要结局

1.Reduction in size of the periapical lesion after root canal treatment with the different apical preparation sizes and taper

时间窗: at baseline and 6 months

次要结局

未报告次要终点

研究者

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

Dr Kaadhambari S

R.V..S Dental College and Hospital

研究点 (1)

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