Outcome of Bone Window Approach in Endodontic Microsurgery Using Novel Piezoelectric Device
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPostgraduate Institute of Dental Sciences Rohtak
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
periapical surgery
Procedure/SurgeryIn piezo group, the periapical surgery will be performed using piezoelectric device.
periapical surgery
Procedure/SurgeryIn conventional bur group, the periapical surgery will be performed using rotary burs.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Piezo groupExperimental treatment 1 intervention
Group B: conventional bur groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year after surgery2
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
Time frame
1 year after surgerySponsors and contacts
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Source ClinicalTrials.gov