- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04737863
Minimally Invasive Management During Endodontic Retreatment
Minimally Invasive Management of Separated Instruments in Vertucci Type ii Canals: A Radomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Faculty of Dentistry, Ainshams University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: selective root canal retreatment
retreatment process is performed to the affected root only
|
Root canal retreatment in cases with secondary root canal infection
|
|
Active Comparator: traditional root canal retreatment
retreatment process is performed to all roots
|
Root canal retreatment in cases with secondary root canal infection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed M Nagy, PhD, Associate professor of Endodontics, Ain Shams University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASFD-ENDO-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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