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Minimally Invasive Management During Endodontic Retreatment

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ClinicalTrials.gov Identifier: NCT04737863
Recruitment Status : Completed
First Posted : February 4, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Mohamed Mokhtar Nagy, Ain Shams University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2020
Actual Primary Completion Date : March 12, 2021
Actual Study Completion Date : April 30, 2021
Arms and Interventions
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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
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Primary Outcome Measures :
  1. volumetric change of periapical lesion size in CBCT [ Time Frame: one year ]
    assessment of healing of periradicular infection in terms of change of the size of periapical lesion in CBCT analysis


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737863


Locations
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Egypt
Faculty of Dentistry, Ainshams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Mohamed M Nagy, PhD Associate professor of Endodontics, Ain Shams University
More Information
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Publications of Results:

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Responsible Party: Mohamed Mokhtar Nagy, Associate Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04737863    
Other Study ID Numbers: ASFD-ENDO-2
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases