Outcome of Bone Window Approach in Endodontic Microsurgery Using Novel Piezoelectric Device

NCT06587048 | Recruiting

• 1 other identifier: keerthana
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The Bone window technique provides excellent access to the surgical site while preserving cortical bone in cases of tooth with large periapical lesion and an intact cortical plate. Traditionally, rotary burs and a bone chisel were used to create a bone window. Piezoelectric bone surgery, on the other hand, is an innovative technique that uses thin osteotomy instrument to selectively cut hard tissue while preserving soft tissues. To the best of our knowledge, no study comparing the results of a bone lid using a piezoelectric device and a conventional bur is currently available.

Conditions

Periapical Lesions; Chronic Apical Periodontitis of Pulpal Origin

Keywords

endondontic microsurgery; piezoelectric device; piezoendodontic surgery; bone window

Outcome Measures

Primary Outcomes (2)

• clinical assessment

  All patients will undergo surgical evaluation 24 h, 48h, 72 h, one week, six months and 12 months after the surgery. Postsurgical pain was measured using the VAS scale.

  1 year after surgery

• Radiographic outcome

  CBCT will be performed 12 months postoperatively, and the findings will be compared with preoperative CBCT findings to assess the bone defect fill and cortical plate formation using modified PENN 3D criteria and RAC index

  1 year after surgery

Study Arms (2)

Piezo group

EXPERIMENTAL

The bone window osteotomy will be created with a piezoelectric device during endodontic microsurgery

Procedure: periapical surgery

conventional bur group

ACTIVE COMPARATOR

The bone window osteotomy will be created with a conventional rotary burs in slow-speed handpiece during endodontic microsurgery

Procedure: periapical surgery

Interventions

periapical surgery PROCEDURE

In piezo group, the periapical surgery will be performed using piezoelectric device.

Piezo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Consenting adults (age range: 18-60 years)
• Non-contributory medical history (ASA Class I or Class 2)
• Participants with symptomatic/persistent apical periodontitis showing clinical signs and symptoms and evidence of periapical lesion of strictly endodontic origin with minimum lesion diameter of 5mm on periapical radiography (PR).
• Radiographic evidence of an intact buccal cortical plate on cone-beam computed tomographic (CBCT) imaging with minimum thickness of 1mm.

You may not qualify if:

• Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension, hepatic/renal disease, or systemic bleeding disorders), pregnancy, smoking
• Patients on anticoagulant/ antiplatelet drugs
• Teeth that were unrestorable, fractured/perforated teeth,
• Teeth with endodontic-periodontal communication and
• Teeth with deep pockets (probing depth \>4 mm)

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

Central Study Contacts

sanjay tewari, MDS conservative dentistry 941

CONTACT

9416259534; tewarisanjayrohtak@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: May 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IN (1)