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Clinical Trials/NCT06031792
NCT06031792
Recruiting
Not Applicable

A 2D and 3D Radiographic Assessment of the Healing Pattern Associated With Conventional and Piezoelectric Periradicular Endodontic Microsurgery

King Abdullah University Hospital1 site in 1 country44 target enrollmentSeptember 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periapical; Infection
Sponsor
King Abdullah University Hospital
Enrollment
44
Locations
1
Primary Endpoint
Radiographic Healing
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Endodontic periradicular microsurgery is a dental procedure to treat apical periodontitis in cases in which healing has not occurred after non-surgical treatment or if it is not feasible. Recent advances in techniques and materials have resulted in more predictable outcomes. Piezotome is a new and innovative device, but limited evidence is available regarding its use in endodontics. The aim of this study is to assess the healing pattern of conventional periradicular microsurgery and piezoelectric periradicular microsurgery in 2- Dimensional and 3-Dimensional imaging, and further to perform histological analysis for the presence, location, and arrangement of bacteria in the excised apical portion of the root canal system.

Detailed Description

After meeting the inclusion criteria, a total of 44 Patients in need of endodontic microsurgery with persistent symptoms after acceptable primary root canal treatment or failed retreatment with persistent symptoms/periapical lesions will be included in this study. Participants will be randomly allocated to group one; conventional periradicular surgery or group two; piezoelectric periradicular microsurgery. A preoperative digital periapical and limited view cone beam computed tomography (CBCT) radiographs will be taken for each patient. At 12-18 months recall visit a second digital periapical radiograph and limited view CBCT will be taken. All images will be evaluated on high-definition LCD display with installed ImageJ software and CBCT software, and window settings will be fixed for all cases. Radiographs will be evaluated by two calibrated dentists. The excised root tip with their surrounding tissues will be fixed immediately after harvesting for 24 hours at 4 °C by immersion in 1% glutaraldehyde and 1% formaldehyde and referred to histopathologic laboratory. Fixed specimens will be demineralized in 10% formic acid and processed. Serial sectioning with hematoxylin and eosin staining will be done to locate the areas with the most severe reactions. In addition, the Taylor modification of the Brown-Brenn staining will be used to detect the presence of bacteria.

Registry
clinicaltrials.gov
Start Date
September 30, 2021
End Date
September 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Medically fit patients
  • Age (18-65 )
  • Teeth that are periodontally healthy
  • Coronally sealed root canal treated teeth

Exclusion Criteria

  • Patients with an active systematic disease that may affect the short- and long-term outcomes or restrict surgical intervention
  • Emotionally distressed patients
  • Patients who had received analgesics or antibiotics prior to surgery will be postponed
  • Cases where orthograde endodontic treatment is feasible, will be retreated at the post-graduate clinics and not included in this study
  • Teeth with poor prognosis (e.g., non-restorable, vertical root fracture, short roots, non-strategic tooth, endo-perio lesion

Outcomes

Primary Outcomes

Radiographic Healing

Time Frame: to measure periapical lesion through study completion, an average of 1 year

To compare conventional and piezotome endodontic apical surgery in terms of healing using 2-Dimensional and 3-Dimensional imaging CBCT.

Histological outcome

Time Frame: one sample is taken and compared immediately after surgery

To correlate histological findings with clinical observation and radiographic findings for failed root canal treated teeth presenting

Study Sites (1)

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