Success Rates for Management of Separated Instruments

NCT05342246 | Completed

• 1 other identifier: FDASU-Rec IR012249
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Teeth, Endodontically-Treated

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

conservative treatment

EXPERIMENTAL

The patent canal is retreated, no attempt to deal with the separated instrument

Procedure: Endodontic retreatment

traditional

ACTIVE COMPARATOR

All canals are retreated with attempts to retrieve the broken file

Procedure: Endodontic retreatment

Interventions

Endodontic retreatment PROCEDURE

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

conservative treatment; traditional

Eligibility Criteria

• Age: 33 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ainshams University

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 8143573 RESULT

• 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.

  PMID: 14651285 RESULT

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: April 22, 2022
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)