Periapical DiseasesNCT05863728
Post-Operative Evaluation of Endodontic Microsurgeries Done Using a Piezoelectric Ultrasonic Technique: An in Vivo Study
A study testing Piezosurgery assisted group and Trephine Bur assisted group in people with Periapical Diseases and Endodontic Overfill, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Periapical Diseases, Endodontic Overfill, Healing Surgical Wounds
- What is being tested?
- Piezosurgery assisted group and Trephine Bur assisted group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 5 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Being tested
- Piezosurgery assisted group, Trephine Bur assisted group
- Keywords
- Endodontic Microsurgery, Piezosurgery, Trephine bur
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezosurgery assisted groupProcedure or surgery
apicectomy will be done using the Piezosurgery device
Trephine Bur assisted groupProcedure or surgery
apicectomy will be done using the trephine burs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Trephine Bur assisted group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 120 hours
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Jan 2020
- Primary completion1 Oct 2022
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical DiseasesStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Yehia Abouel Naga, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863728
- Sponsor's protocol ID
- 31/5/2020
- Status last verified
- May 2023
- First submitted
- 6 Apr 2023
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Evaluation of Endodontic Microsurgeries Done Using a Piezoelectric Ultrasonic Technique: An in Vivo Study
- ClinicalTrials.gov ID
- NCT05863728
- Acronym / sponsor ID
- 31/5/2020
- Keywords
- Endodontic Microsurgery, Piezosurgery, Trephine bur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezosurgery assisted group | Experimental | Procedure: Piezosurgery assisted groupA 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 Burs assisted group | Experimental | Procedure: Trephine Bur assisted groupTrephine 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piezosurgery assisted groupapicectomy will be done using the Piezosurgery device | Procedure or surgery | Piezosurgery assisted group |
| Trephine Bur assisted groupapicectomy will be done using the trephine burs | Procedure or surgery | Trephine Burs assisted group |
Primary outcome
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).
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).
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).
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).
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).
5 secondary outcomes
Postoperative swelling assessment
Time frame: 24 hours
Postoperative swelling assessment
Time frame: 48 hours
Postoperative swelling assessment
Time frame: 72 hours
Postoperative swelling assessment
Time frame: 96 hours
Postoperative swelling assessment
Time frame: 120 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezosurgery assisted group and Trephine Bur assisted group in people with Periapical Diseases and Endodontic Overfill, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain assessment (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.