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临床试验/NCT07614451
NCT07614451尚未招募不适用

A Prospective Clinical Evaluation of Indirect Overlay Restorations With Different Cavity Preparation Designs in Endodontically Treated Molars: Two Year Randomized Clinical Trial

Cairo University0 个研究点目标入组 50 人开始时间: 2026年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50

研究概览

简要总结

This study is conducted to evaluate the clinical performance of indirect overlay restorations with different cavity preparation designs in endodontically treated molars over two years.

详细描述

First Validation of endodontic treatment using a periapical radiograph and proper history taking.

{I}• Cavity Preparation Procedures for Comparator Group:

  • Removal of any remnants of temporary filling and excess gutta percha to the level of root canal orifice.
  • Removal of all undermined enamel.
  • Then 1.5 to 2 mm cusp reduction will be performed for the buccal and lingual walls.
  • The occlusal box will be of 2.5 mm width, 2 mm depth cavity walls and will be flared to produce a 6 degree of divergence.
  • The cavity will have internal rounded angles, finished enamel with sharp non-beveled margins and smooth well-defined walls.
  • Immediate Dentin Sealing and Cavity Optimization: Immediate dentin sealing will be performed through the use of a universal adhesive followed by the injection of injectable flowable resin composite. Blocking of undercuts using injectable flowable resin composite and margin elevation if required.
  • The final retentive design will include occlusal clearance of 2 mm with occlusal box cavity of depth 2 mm with all margins in enamel occlusally and all dentin surfaces will be covered.

{II}• Cavity Preparation Procedures for Intervention Group:

  • Removal of any remnants of temporary filling and excess gutta percha to the level of root canal orifice.
  • No additional removal of the tooth structure will be performed at this step.
  • Cavity optimization will be performed first.
  • Blocking of undercuts using injectable flowable resin composite and margin elevation if required.
  • The occlusal cavity will be restored during cavity optimization with injectable resin composite to reduce the areas of dentin exposure and preserve the remaining tooth structure.
  • The dentin substitute resin composite will establish the biobase.
  • An anatomical non retentive preparation design will be performed to show continuous inclined plane preparation with 2 mm cuspal reduction, concave chamfer margins, and 1 to 1.5 mm thick butt-joint preparation in the interproximal portion.
  • The final cavity design will include occlusal clearance of 2 mm with total cusp coverage, with biomimetic features (anatomical, non-retentive design) with no occlusal box cavity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient Related Criteria:
  • Adult patients (age: 20-60 years) of both genders.
  • Healthy patients (not suffering of any systematic or chronic diseases).
  • Able to tolerate the necessary restorative procedures.
  • Willing to sign the informed ethical consent.
  • Accepts the follow-up period.
  • Tooth Related Criteria:
  • Proper endodontically treated teeth.
  • First and second permanent molars.
  • Absence of any peri-apical lesions.
  • Absence of any periodontal disease involvement.
  • Large access cavities with one or two missing walls.
  • Patients with proper oral hygiene.
  • Presence of opposing tooth.

排除标准

  • Patient related:
  • Patients younger than 20 or older than 60 years old.
  • Pregnant females.
  • Patients with any systemic or chronic diseases.
  • Patients not accepting the follow-up period.
  • Patients not willing to sign the informed ethical consent.
  • Patients with known allergies to latex and/or resinous material.
  • Tooth related
  • Endodontically treated anterior, premolar and third molar teeth.
  • Hopelessly carious/destructed teeth necessitating extraction.
  • Mobile teeth, indicating periodontal disease or trauma.
  • External or internal resorption.
  • Poor endodontic treatment.
  • Periapical lesion present.
  • Cervical carious lesions involved.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Ibrahim Mohamed Fahmy

part-time assistant lecturer

Cairo University

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