Minimally Invasive Management During Endodontic Retreatment

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04737863

Collaborator

(none)

Enrollment

Location

Arms

15.9

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Teeth, Endodontically-Treated	Procedure: Endodontic retreatment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Mar 12, 2021

Actual Study Completion Date :

Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: selective root canal retreatment retreatment process is performed to the affected root only	Procedure: Endodontic retreatment Root canal retreatment in cases with secondary root canal infection
Active Comparator: traditional root canal retreatment retreatment process is performed to all roots	Procedure: Endodontic retreatment Root canal retreatment in cases with secondary root canal infection

Arm

Intervention/Treatment

Experimental: selective root canal retreatment

retreatment process is performed to the affected root only

Procedure: Endodontic retreatment

Root canal retreatment in cases with secondary root canal infection

Active Comparator: traditional root canal retreatment

retreatment process is performed to all roots

Procedure: Endodontic retreatment

Root canal retreatment in cases with secondary root canal infection

Outcome Measures

Primary Outcome Measures

volumetric change of periapical lesion size in CBCT [one year]
assessment of healing of periradicular infection in terms of change of the size of periapical lesion in CBCT analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Ainshams University	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Mohamed M Nagy, PhD, Associate professor of Endodontics, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Mokhtar Nagy, Associate Professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT04737863

Other Study ID Numbers:

ASFD-ENDO-2

First Posted:

Feb 4, 2021

Last Update Posted:

Jul 27, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tooth, Nonvital

Study Results

No Results Posted as of Jul 27, 2021