Post-Operative Evaluation of Endodontic Microsurgeries Done Using a Piezoelectric Ultrasonic Technique: An in Vivo Study

The aim of the study was to evaluate the effect of Piezosurgery and Trephine bur as cutting tools on post-operative sequelae including pain and swelling following guided endodontic microsurgeries.

Study Overview

• Status: Completed
• Conditions: Periapical Diseases; Healing Surgical Wounds; Endodontic Overfill
• Intervention / Treatment: Procedure: Piezosurgery assisted group; Procedure: Trephine Bur assisted group

Detailed Description

Materials and Methods: Twenty healthy male patients aged between 18 and 45 years old were selected in the study. Mandibular first molar teeth with failed non-surgical treatment or re-treatment due to iatrogenic errors at the apical 3mm of the mesial root canal including canal ledging, zipping and transportation, root perforation, separated instrument, and canal calcification were selected. Piezosurgery assisted cavity preparation and root-end resection were performed in Groups I and II, and Trephine bur assisted cavity and root-end resection was performed in Groups III and IV. An apical curettage was performed and the over-extended objects such as separated instruments or gutta percha were removed. The PRF clots was placed inside the bone cavity in groups I and III while the bone cavity was kept for 2 min to allow the blood clots to be formed in groups II and IV. The degree of pain and swelling were recorded for five days every 24, 48, 72, 96, and 120 hours postoperatively.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11651
    • Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Mandibular first molar teeth were selected according to specific inclusion criteria including:

1. Teeth presented with failed non-surgical treatment or re-treatment. Failure is due to iatrogenic errors at the apical 3mm of the mesial root canal including canal ledging, zipping and transportation, root perforation, separated instrument and canal calcification.
2. Teeth presented with normal pocket depth ranges from 1 to 3mm, up to grade II tooth mobility.
3. Teeth presented without periapical radiolucency (Class A) or with periapical radiolucency not more than 1 mm in diameter both mesiodistally and buccolingually (Class B) according to the preoperative endodontic microsurgical classification of teeth.
4. Teeth presented with non-fused mesial and distal roots and the mesial roots are range from 10 to 15 mm. in length, Type III root canal configuration (Two canals run separately from orifice to apex). The root canal curvature angle was measured using the Weine technique to be not less than 160° in both directions buccolingually and mesiodistally.
5. At the apical 3 mm of the mesial radiographic root apex, the distance from the outer surface of the buccal cortical plate of bone to the buccal side of the mesial root is 1.5 mm (Depth I). The buccolingual dimension of the mesial root is 7 mm mm (Depth II). The distance from the lingual surface of the mesial root to the outer surface of the lingual cortical plate of bone is 3.5 mm. (Depth III).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Piezosurgery assisted group; A Piezosurgery assisted cavity preparation was performed using a IM4A Piezosurgery tip mounted in the handpiece of a Piezosurgery device (PIEZOSURGERY touch, Mectron, Carasco, Italy) at an operating frequency in the range of 24 to 36 kHz with power ratings 55 W for osteotomy and root-end resection	Procedure: Piezosurgery assisted group; apicectomy will be done using the Piezosurgery device
Experimental: Trephine Burs assisted group; Trephine bur assisted cavity preparation was performed using a TPB-4 trephine bur mounted in 20:1 contra angled handpiece of an implant motor (ImplaNX, Micro-NX, Republic of Korea) at an operating speed in the range of 800 to 1200 / Torque 30 N for osteotomy and root-end resection	Procedure: Trephine Bur assisted group; apicectomy will be done using the trephine burs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain assessment	The postoperative pain assessment was done using the modified verbal descriptor scale as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).	24 hours
Postoperative pain assessment	The postoperative pain assessment was done using the modified verbal descriptor scale as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).	48 hours
Postoperative pain assessment	The postoperative pain assessment was done using the modified verbal descriptor scale as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).	72 hours
Postoperative pain assessment	The postoperative pain assessment was done using the modified verbal descriptor scale as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).	96 hours
Postoperative pain assessment	The postoperative pain assessment was done using the modified verbal descriptor scale as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).	120 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative swelling assessment	Patients were instructed to the description of each level of swelling as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).	24 hours
Postoperative swelling assessment	Patients were instructed to the description of each level of swelling as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).	48 hours
Postoperative swelling assessment	Patients were instructed to the description of each level of swelling as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).	72 hours
Postoperative swelling assessment	Patients were instructed to the description of each level of swelling as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).	96 hours
Postoperative swelling assessment	Patients were instructed to the description of each level of swelling as follows; None (Score 0), Mild (Score 1), Moderate (Score 2), and Severe (Score 3).	120 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative CBCT scans	Evaluation of surgical endodontic healing according to Modified PENN 3D criteria	6 months
Post-operative CBCT scans	Evaluation of surgical endodontic healing according to Modified PENN 3D criteria	12 months

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): January 5, 2023

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Piezosurgery; Endodontic Microsurgery; Trephine bur
• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Surgical Wound; Periapical Diseases
• Other Study ID Numbers: 31/5/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No