Radiographic Assessment of the Healing Pattern Associated With Periradicular Endodontic Microsurgery

NCT06031792 | Recruiting

• 1 other identifier: KingAbdullahUH1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Periapical; Infection

Outcome Measures

Primary Outcomes (2)

• Radiographic Healing

  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

• Histological outcome

  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

Study Arms (2)

Piezo endodontic surgery

EXPERIMENTAL

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

Conventional endodontic surgery

EXPERIMENTAL

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

Interventions

Piezo endodontic surgery 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.

Piezo endodontic surgery

Conventional endodontic surgery 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.

Conventional endodontic surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (2)

Jordan University of Science and Technology

Irbid, POBOX 3030, Jordan

RECRUITING

Jordan University of Science and Technology

Irbid, POBOX 3030, Jordan

RECRUITING

MeSH Terms

Conditions

Infections

Central Study Contacts

Lama A Awawdeh, PhD

CONTACT

+962795412954; lawawdeh@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized prospective clinical study

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: September 30, 2021
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

JO (2)