Clinical trial NCT06031792: Radiographic Assessment of the Healing Pattern Associated With Periradicular Endodontic Microsurgery
Official title: A 2D and 3D Radiographic Assessment of the Healing Pattern Associated With Conventional and Piezoelectric Periradicular Endodontic Microsurgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periapical; Infection
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2023-09-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized prospective clinical study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Radiographic Healing
timeFrame: to measure periapical lesion through study completion, an average of 1 year
measure: Histological outcome
timeFrame: one sample is taken and compared immediately after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
References: