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Completed

NCT Number: NCT05863728

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar university

Cairo, 11651, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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).

Treatment and study plan

Piezosurgery assisted group

Procedure

apicectomy will be done using the Piezosurgery device

Trephine Bur assisted group

Procedure

apicectomy will be done using the trephine burs

Primary outcomes

  1. Postoperative pain assessment

    Time frame: 24 hours

    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).

  2. Postoperative pain assessment

    Time frame: 48 hours

    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).

  3. Postoperative pain assessment

    Time frame: 72 hours

    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).

  4. Postoperative pain assessment

    Time frame: 96 hours

    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).

  5. Postoperative pain assessment

    Time frame: 120 hours

    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).

Secondary outcomes

  1. Postoperative swelling assessment

    Time frame: 24 hours

    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).

  2. Postoperative swelling assessment

    Time frame: 48 hours

    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).

  3. Postoperative swelling assessment

    Time frame: 72 hours

    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).

  4. Postoperative swelling assessment

    Time frame: 96 hours

    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).

  5. Postoperative swelling assessment

    Time frame: 120 hours

    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).

Other outcomes

  1. Post-operative CBCT scans

    Time frame: 6 months

    Evaluation of surgical endodontic healing according to Modified PENN 3D criteria

  2. Post-operative CBCT scans

    Time frame: 12 months

    Evaluation of surgical endodontic healing according to Modified PENN 3D criteria

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 18, 2023
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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