Radiographic Assessment of the Healing Pattern Associated With Periradicular Endodontic Microsurgery

NCT ID: NCT06031792

Last Updated: 2024-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Periapical; Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized prospective clinical study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Piezo endodontic surgery

Intervention Type PROCEDURE

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.

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

Group Type EXPERIMENTAL

Conventional endodontic surgery

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jordan University of Science and Technology

OTHER

Sponsor Role collaborator

King Abdullah University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jordan University of Science and Technology

Irbid, , Jordan

Site Status RECRUITING

Jordan University of Science and Technology

Irbid, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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Lama A Awawdeh, PhD

Role: CONTACT

+962795412954

Facility Contacts

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Lama A Awawdeh, PhD

Role: primary

0795412954

Lama A Awawdeh, PhD

Role: primary

+962795412954

Other Identifiers

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KingAbdullahUH1

Identifier Type: -

Identifier Source: org_study_id

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