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Completed

NCT Number: NCT05342246

Success Rates for Management of Separated Instruments

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

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Key information

Conditions

Teeth, Endodontically-Treated Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases Tooth, Nonvital

Age range

33 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Ainshams University

Cairo, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Endodontic Retreatment

Procedure

retreatment of the patent root canal only without attempt to retrieve the separated instrument

Primary outcomes

  1. monitoring of periapical index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Success Rates for Management of Separated Instruments in Canals With Type II Vertucci's Classification: Prospective Clinical Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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