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

NCT06587048 · tracked via the Priya Life Science India tracker

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Phase

Not applicable

Started

2023-09-01

Last updated

2024-09-19

Condition(s) studied

Periapical LesionsChronic Apical Periodontitis of Pulpal Origin

Investigational drug(s) / intervention(s)

periapical surgeryperiapical surgery

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

periapical surgery: In conventional bur group, the periapical surgery will be performed using rotary burs.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: * • 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. Exclusion Criteria: * 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)

Primary outcome measure(s)

clinical assessment — 1 year after surgery
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.
Radiographic outcome — 1 year after surgery
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

Trial sites (1)

Facility	City	Region	Status
Post Graduate Institute of Dental Sciences	Rohtak	Haryana	Recruiting