Radiographic Assessment of the Healing Pattern Associated With Periradicular Endodontic Microsurgery

Not Applicable

Recruiting

• Conditions: Periapical; Infection
• Interventions: Procedure: Conventional endodontic surgery; Procedure: Piezo endodontic surgery

• Registration Number: NCT06031792
• Lead Sponsor: King Abdullah University Hospital

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.

Study Timeline

• Study Start: 2021-09-30
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-17
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional endodontic surgery	Conventional endodontic surgery	Experimental: Conventional endodontic surgery The osteotomy will be applied under magnification with a surgical operating microscope at the apical third of the root. Osteotomy will be done with air motor high speed hand-piece and round bur with copious irrigation
Piezo endodontic surgery	Piezo endodontic surgery	Experimental: Piezo endodontic surgery The osteotomy will be applied under magnification with a surgical operating microscope (at the apical third of the root. Osteotomy will be done with the Piezosurgery touch

Primary Outcome Measures

Name	Time	Method
Radiographic Healing	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	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

Trial Locations

Locations (1)

Jordan University of Science and Technology; 🇯🇴 Irbid, Jordan