Maxillofacial, OsteotomyNCT05202444
The Use of Piezoelectric Surgery for Osteotomies
A study testing Osteotomy using piezoelectrical device in people with Maxillofacial, Osteotomy, run by Minia University at 1 site in Egypt.
Trial summary
Piezo-surgery was first used in oral and maxillofacial surgery in 2001 by Vercellotti and colleagues to simplify maxillary sinus surgery by avoiding perforation of the schneiderian membrane. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillofacial, Osteotomy
- What is being tested?
- Osteotomy using piezoelectrical device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 20 Mar 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ranged from 18 to 35 years.
- Patients were not suffering from systemic diseases that compromise wound or bone healing.
- Patients indicated for leforte I or maxillary subapical osteotomy.
- Patients agree the informed consent .
Who cannot join
- Patients suffering from systemic disease that may affect bleeding or bone healing
- Syndromicdentofacial deformity patients.
- Patients were subjected to previous maxillary orthognathic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Using Piezoelectric Device Versus Conventional Saw for Osteotomy in Maxillary Orthognathic Surgery
Piezo-surgery was first used in oral and maxillofacial surgery in 2001 by Vercellotti and colleagues to simplify maxillary sinus surgery by avoiding perforation of the schneiderian membrane. Later on ultrasonic bone cutting has been used in orthognathic procedures, extraction of impacted third molars , cyst enucleation, implant site preparation, temporomandibular join surgery , corticotomy-facilitated orthodontics, and head and neck oncological and reconstructive surgeries.
- Conditions
- Maxillofacial, Osteotomy
- Being tested
- Osteotomy using piezoelectrical device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteotomy using piezoelectrical deviceProcedure or surgery
osteotomy were utilized using piezoelectric from device (Woodpeker) with its internal irrigation system. We used US2 tip using the maximum bone cutting program and maximum irrigation program for lateral maxillary wall osteotomy and USIR tip for the posterior maxillary wall osteotomy.
The pterygoid osteotome was placed between the tuberosity and pterygoid plates while the hamulus is palpated palatally with the index finger to guide the osteotome direction preventing palatal perforation.With the pterygoid osteotome still in position, we used a thin osteotome to complete the osteotomy of the posterior wall of the maxilla.
| Study group | Role | What they receive |
|---|---|---|
| Osteotomy using piezoelectrical device | Experimental | Not described Receives: Procedure: Osteotomy using piezoelectrical device |
| Osteotomy using surgical saw | Active comparator | Not described Receives: Procedure: Osteotomy using piezoelectrical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative Bleeding
Measured: From begining of the surgery till the end
Osteotomy Time
Measured: From begining of the surgery till the end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Nov 2019
- Primary completion5 Sep 2020
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial, OsteotomyStudies of the same condition, open and under way.
- More trials run by Minia 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Collaborators
- Dar Al Shifa Hospital
- Responsible party
- Principal investigator, Abdullah Hammuda, Suez University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202444
- Sponsor's protocol ID
- 281
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2022
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Using Piezoelectric Device Versus Conventional Saw for Osteotomy in Maxillary Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT05202444
- Acronym / sponsor ID
- 281
- Conditions
- Maxillofacial, Osteotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Collaborators
- Dar Al Shifa Hospital
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 5 Sep 2020 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 21 Jan 2022 (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.
Piezo-surgery was first used in oral and maxillofacial surgery in 2001 by Vercellotti and colleagues to simplify maxillary sinus surgery by avoiding perforation of the schneiderian membrane. Later on ultrasonic bone cutting has been used in orthognathic procedures, extraction of impacted third molars , cyst enucleation, implant site preparation, temporomandibular join surgery , corticotomy-facilitated orthodontics, and head and neck oncological and reconstructive surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteotomy using piezoelectrical device | Experimental | Procedure: Osteotomy using piezoelectrical device |
| Osteotomy using surgical saw | Active comparator | Procedure: Osteotomy using piezoelectrical device |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranged from 18 to 35 years.
- Patients were not suffering from systemic diseases that compromise wound or bone healing.
- Patients indicated for leforte I or maxillary subapical osteotomy.
- Patients agree the informed consent .
Key exclusion criteria (3 listed)
- Patients suffering from systemic disease that may affect bleeding or bone healing
- Syndromicdentofacial deformity patients.
- Patients were subjected to previous maxillary orthognathic surgery.
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 |
|---|---|---|
| Osteotomy using piezoelectrical deviceosteotomy were utilized using piezoelectric from device (Woodpeker) with its internal irrigation system. We used US2 tip using the maximum bone cutting program and maximum irrigation program for lateral maxillary wall osteotomy and USIR tip for the posterior maxillary wall osteotomy. The pterygoid osteotome was placed between the tuberosity and pterygoid plates while the hamulus is palpated palatally with the index finger to guide the osteotome direction preventing palatal perforation.With the pterygoid osteotome still in position, we used a thin osteotome to complete the osteotomy of the posterior wall of the maxilla. | Procedure or surgery | Osteotomy using piezoelectrical device, Osteotomy using surgical saw |
Primary outcome
Intra-operative Bleeding
Time frame: From begining of the surgery till the end
Osteotomy Time
Time frame: From begining of the surgery till the end
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 21 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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 Osteotomy using piezoelectrical device in people with Maxillofacial, Osteotomy, run by Minia 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 4 inclusion and 3 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 21 Jan 2022. 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?
Intra-operative Bleeding (time frame: From begining of the surgery till the end). The study lists 2 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 21 Jan 2022.