Radiographic Assessment of the Healing Pattern Associated With Periradicular Endodontic Microsurgery

June 13, 2024 updated by: King Abdullah University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Jordan
      • Irbid, Jordan, POBOX 3030
        • Recruiting
        • Jordan University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: 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
Procedure: Piezo endodontic surgery
Osteotomy will be done with Piezosurgery touch. After the soft tissue curettage and uncovering the root apex, the last 3 mm of the root apex will be resected perpendicular to the long axis of the tooth using piezotome. apical preparation will be performed and Biodentine®retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament suture will be applied. Finally, Post-operative parallel Digital view.
Experimental: 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
Procedure: Conventional endodontic surgery
After the soft tissue curettage and exposure of the root apex, the osteotomy will be performed using a conventional surgical handpiece. The same steps will be followed to prepare and restore the root, as well as to reposition the flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one sample is taken and compared immediately after surgery
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.
to measure periapical lesion through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah University Hospital

Collaborators

Jordan University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • KingAbdullahUH1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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