Success Rates for Management of Separated Instruments

Not Applicable

Completed

• Conditions: Teeth, Endodontically-Treated
• Interventions: Procedure: Endodontic retreatment

• Registration Number: NCT05342246
• Lead Sponsor: Ain Shams University

Brief Summary

The study compares the prognosis of cases of Separated Instruments in Canals With Type II Vertucci's Classification treated with conservative approach

Detailed Description

Teeth with Type II Vertucci root canal configuration are having more incidence of instruments separation due the presence of an S-type (Double curve). The aim of this study is to compare the outcome of minimally invasive approach (MIA), retaining the separated in one root canal, cleaning and shaping of portals of entry of the two canals and portal of exit of both canals through the other patent canal, in comparison to the outcome of retrieval of the broken instrument by ultrasonics retrieval techniques (URT)

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-03-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-16
• Study First Submitted QC: 2022-04-16
• Study First Posted: 2022-04-22
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Presence of separated instrument in a root with a Vertucci's type II configuration (the level of the SI was evaluated using CBCT scans)
• Age range 35-55 years
• Teeth having a baseline periapical lesion (PAI score ≥2) in the affected root

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Exclusion Criteria

• • Patients who refused to undergo radiographic follow-up.

  • Pregnant females.
  • Patients suffered from a systemic disease.
  • Teeth with lesions connected to adjacent teeth.
  • Teeth with root fractures or perforations.
  • Teeth with lesion communicating with the alveolar crest.
  • patients with generalized chronic periodontitis or teeth that need periodontal surgery prior to coronal restorations due to marginal deficiency
  • teeth with damaged or resorbed peri- apex
  • teeth that were treated with a fiber post and teeth with canal curvature more than 25 degrees

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conservative treatment	Endodontic retreatment	The patent canal is retreated, no attempt to deal with the separated instrument
traditional	Endodontic retreatment	All canals are retreated with attempts to retrieve the broken file

Primary Outcome Measures

Name	Time	Method
monitoring of periapical index	2 years	The peri-radicular condition was evaluated using the Periapical Index (PAI) created by Ørstavik et al. (1986). The PAI includes five grades represented on an ordinal scale as follows: (1) normal periapical structures; (2) small changes in the periapical bone or bone structure; (3) changes in the periapical bone structure with mineral loss, characteristic of apical periodontitis; (4) demineralization of the periapical bone within a well-defined radiolucent area; and (5) demineralization of the periapical bone with exacerbations and expansion in bone structure.

Trial Locations

Locations (1)

Faculty of Dentistry, Ainshams University; 🇪🇬 Cairo, Egypt