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

NCT05863728 | Completed

• 1 other identifier: 31/5/2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periapical Diseases; Endodontic Overfill; Healing Surgical Wounds

Keywords

Endodontic Microsurgery; Piezosurgery; Trephine bur

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Postoperative swelling assessment

  24 hours

• Postoperative swelling assessment

  48 hours

• Postoperative swelling assessment

  72 hours

• Postoperative swelling assessment

  96 hours

• Postoperative swelling assessment

  120 hours

Other Outcomes (2)

• Post-operative CBCT scans

  6 months

• Post-operative CBCT scans

  12 months

Study Arms (2)

Piezosurgery assisted group

EXPERIMENTAL

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

Trephine Burs assisted group

EXPERIMENTAL

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

Interventions

Piezosurgery assisted group PROCEDURE

apicectomy will be done using the Piezosurgery device

Piezosurgery assisted group

Trephine Bur assisted group PROCEDURE

apicectomy will be done using the trephine burs

Trephine Burs assisted group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Teeth presented with normal pocket depth ranges from 1 to 3mm, up to grade II tooth mobility.
• 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.
• 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.
• 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).

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar university

Cairo, 11651, Egypt

Location

MeSH Terms

Conditions

Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/ Assistant Lecturer

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 18, 2023
• Study Start: January 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: January 5, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Locations

EG (1)