Success Rates for Management of Separated Instruments

Teeth, Endodontically-Treated Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05342246
• Other study ID #: FDASU-Rec IR012249
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 33 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Teeth, Endodontically-Treated
• Tooth, Nonvital

Intervention

Procedure:
• Endodontic retreatment
retreatment of the patent root canal only without attempt to retrieve the separated instrument

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Ainshams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Hülsmann M. Methods for removing metal obstructions from the root canal. Endod Dent Traumatol. 1993 Dec;9(6):223-37. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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