Back to resultsPost-Operative Evaluation of Endodontic Microsurgeries Done Using a Piezoelectric Ultrasonic Technique: An in Vivo Study
Primary Purpose
Periapical Diseases, Endodontic Overfill, Healing Surgical Wounds
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Piezosurgery assisted group
Trephine Bur assisted group
Sponsored by
About this trial
This is an interventional treatment trial for Periapical Diseases focused on measuring Endodontic Microsurgery, Piezosurgery, Trephine bur
Eligibility Criteria
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).
Sites / Locations
- Al-Azhar university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Piezosurgery assisted group
Trephine Burs assisted group
Arm Description
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
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
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05863728
Brief Title
Post-Operative Evaluation of Endodontic Microsurgeries Done Using a Piezoelectric Ultrasonic Technique: An in Vivo Study
Official Title
Post-Operative Evaluation of Endodontic Microsurgeries Done Using a Piezoelectric Ultrasonic Technique: An in Vivo Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
January 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Diseases, Endodontic Overfill, Healing Surgical Wounds
Keywords
Endodontic Microsurgery, Piezosurgery, Trephine bur
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Piezosurgery assisted group
Arm Type
Experimental
Arm Description
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
Arm Title
Trephine Burs assisted group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Piezosurgery assisted group
Intervention Description
apicectomy will be done using the Piezosurgery device
Intervention Type
Procedure
Intervention Name(s)
Trephine Bur assisted group
Intervention Description
apicectomy will be done using the trephine burs
Primary Outcome Measure Information:
Title
Postoperative pain assessment
Description
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).
Time Frame
24 hours
Title
Postoperative pain assessment
Description
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).
Time Frame
48 hours
Title
Postoperative pain assessment
Description
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).
Time Frame
72 hours
Title
Postoperative pain assessment
Description
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).
Time Frame
96 hours
Title
Postoperative pain assessment
Description
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).
Time Frame
120 hours
Secondary Outcome Measure Information:
Title
Postoperative swelling assessment
Description
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).
Time Frame
24 hours
Title
Postoperative swelling assessment
Description
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).
Time Frame
48 hours
Title
Postoperative swelling assessment
Description
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).
Time Frame
72 hours
Title
Postoperative swelling assessment
Description
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).
Time Frame
96 hours
Title
Postoperative swelling assessment
Description
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).
Time Frame
120 hours
Other Pre-specified Outcome Measures:
Title
Post-operative CBCT scans
Description
Evaluation of surgical endodontic healing according to Modified PENN 3D criteria
Time Frame
6 months
Title
Post-operative CBCT scans
Description
Evaluation of surgical endodontic healing according to Modified PENN 3D criteria
Time Frame
12 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Al-Azhar university
City
Cairo
ZIP/Postal Code
11651
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Post-Operative Evaluation of Endodontic Microsurgeries Done Using a Piezoelectric Ultrasonic Technique: An in Vivo Study
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