Success Rates for Management of Separated Instruments

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

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

Study Overview

• Status: Completed
• Conditions: Teeth, Endodontically-Treated
• Intervention / Treatment: Procedure: Endodontic retreatment

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry, Ainshams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conservative treatment; The patent canal is retreated, no attempt to deal with the separated instrument	Procedure: Endodontic retreatment; retreatment of the patent root canal only without attempt to retrieve the separated instrument
Active Comparator: traditional; All canals are retreated with attempts to retrieve the broken file	Procedure: Endodontic retreatment; retreatment of the patent root canal only without attempt to retrieve the separated instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monitoring of periapical index	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.	2 years

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• Hulsmann M. Methods for removing metal obstructions from the root canal. Endod Dent Traumatol. 1993 Dec;9(6):223-37. doi: 10.1111/j.1600-9657.1993.tb00278.x.
• Ward JR, Parashos P, Messer HH. Evaluation of an ultrasonic technique to remove fractured rotary nickel-titanium endodontic instruments from root canals: an experimental study. J Endod. 2003 Nov;29(11):756-63. doi: 10.1097/00004770-200311000-00017.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: April 16, 2022
• First Submitted That Met QC Criteria: April 16, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: FDASU-Rec IR012249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No