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Minimally Invasive Management During Endodontic Retreatment

Primary Purpose

Teeth, Endodontically-Treated

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Endodontic retreatment

About this trial

This is an interventional treatment trial for Teeth, Endodontically-Treated

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

endodontically treated teeth
multirooted teeth
radiographic evidence of periradicular infection related to one root

Exclusion Criteria:

medically compromised patients
fused roots
root resorption
root fracture

Sites / Locations

Faculty of Dentistry, Ainshams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

selective root canal retreatment

traditional root canal retreatment

Arm Description

retreatment process is performed to the affected root only

retreatment process is performed to all roots

Outcomes

Primary Outcome Measures

volumetric change of periapical lesion size in CBCT

assessment of healing of periradicular infection in terms of change of the size of periapical lesion in CBCT analysis

Secondary Outcome Measures

Full Information

NCT ID

NCT04737863

First Posted

January 30, 2021

Last Updated

July 24, 2021

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04737863

Brief Title

Minimally Invasive Management During Endodontic Retreatment

Official Title

Minimally Invasive Management of Separated Instruments in Vertucci Type ii Canals: A Radomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

March 12, 2021 (Actual)

Study Completion Date

April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study compares the prognosis of cases treated with "selective root retreatment" to the cases treated with traditional retreatment approach

Detailed Description

Post-treatment apical periodontitis is an inflammatory disorder of peri-radicular tissues caused by either persistent or secondary intra-radicular infection .Conventionally, nonsurgical retreatment has been believed to be an ''all or none'' treatment approach in which the endodontist has to remove all restorations from the tooth and to remove the obturation materials from all the canals in order to perform thorough disinfection of the entire root canal system. Nowadays, All operations in the medical field are aimed basically at the conservation of the human body. The alternative concept allows the endodontist to formulate clinical treatment decisions with respect to the presence of periapical pathosis related to individual roots rather than the tooth as a whole. The literature is lacking the clinical outcome studies dealing with the prognosis of cases treated with "selective root retreatment" concept so the aim of this study was to compare the prognosis of such cases in comparison to the traditional retreatment approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Teeth, Endodontically-Treated

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

selective root canal retreatment

Arm Type

Experimental

Arm Description

retreatment process is performed to the affected root only

Arm Title

traditional root canal retreatment

Arm Type

Active Comparator

Arm Description

retreatment process is performed to all roots

Intervention Type

Procedure

Intervention Name(s)

Endodontic retreatment

Intervention Description

Root canal retreatment in cases with secondary root canal infection

Primary Outcome Measure Information:

Title

volumetric change of periapical lesion size in CBCT

Description

assessment of healing of periradicular infection in terms of change of the size of periapical lesion in CBCT analysis

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: endodontically treated teeth multirooted teeth radiographic evidence of periradicular infection related to one root Exclusion Criteria: medically compromised patients fused roots root resorption root fracture

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed M Nagy, PhD

Organizational Affiliation

Associate professor of Endodontics, Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Dentistry, Ainshams University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25906919

Citation

Nudera WJ. Selective Root Retreatment: A Novel Approach. J Endod. 2015 Aug;41(8):1382-8. doi: 10.1016/j.joen.2015.02.035. Epub 2015 Apr 21.

Results Reference

result

PubMed Identifier

21329816

Citation

Liang YH, Li G, Wesselink PR, Wu MK. Endodontic outcome predictors identified with periapical radiographs and cone-beam computed tomography scans. J Endod. 2011 Mar;37(3):326-31. doi: 10.1016/j.joen.2010.11.032.

Results Reference

result

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Minimally Invasive Management During Endodontic Retreatment

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