Nasal Deformity, AcquiredNCT06094348
The Evaluation of Piezo and Endonasal Osteotomy Methods on Postoperative Healing Process in Septorhinoplasty
An observational study of Nasal Deformity, Acquired and Septum; Deviation, Congenital, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question[s] it aims to answer are: In which osteotomy technique the edema is lesser? Which osteotomy technique is better for thick… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Deformity, Acquired, Septum; Deviation, Congenital
- What is being tested?
- Endonasal osteotomy and Piezo assisted osteotomy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2023to 19 Apr 2024
- How long will I take part?
- 10 Months
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-65 year, males or females with nasal septum and/or nasal pyramid deviation and external nasal deformities who are willing to undergo open rhinoplasty procedure.
Who may be able to join
- nasal respiratory dysfunction with the deviation of nasal septum and/or the nasal pyramid
Who cannot join
- previous rhinoplasty/septorhinoplasty procedure
- patients with abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time)
- use of anticoagulant drugs
- chronic / inflammatory skin disease and/or chronic skin allergies
- presence of systemic diseases (hypertension, diabetes mellitus, bronchial asthma)
- nasal beautification procedures such as dermal fillings
- use of oral and/or topical (nasal skin) corticosteroids in three months preoperatively
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Haseki Training and Research Hospital
Istanbul
Isil Taylan Cebi, M.D, 00905072352256, drisiltaylan@hotmail.com
Abdullah Karatas, Assoc. Prof., 00905326230218, akrts2000@yahoo.ca
About this study
Official title: The Evaluation of the Effect of Piezo and Endonasal Osteotomy Methods on Postoperative Healing Process in Septorhinoplasty by the Ultrasonic Measurement of Nasal Skin Thickness
The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question[s] it aims to answer are:
- In which osteotomy technique the edema is lesser?
- Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster?
Read more
Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively.
Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements)
Read the detailed description
The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question[s] it aims to answer are:
- In which osteotomy technique the edema is lesser?
- Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster?
18-65 years old males or females with nasal septum and/or nasal pyramid deviation and external nasal deformities who are willing to undergo open rhinoplasty procedure will be included in the study. Patients who have a history of previous rhinoplasty/septorhinoplasty procedure, abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time), use of anticoagulant drugs, chronic / inflammatory skin disease and/or chronic skin allergies, systemic diseases (hypertension, diabetes mellitus, bronchial asthma), nasal beautification procedures such as dermal fillings, using oral and/or topical (nasal skin) corticosteroids in three months preoperatively will be excluded.
Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively.
Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements).
- Being tested
- Endonasal osteotomy, Piezo assisted osteotomy
- Keywords
- rhinoplasty, edema, piezosurgery, osteotomy
- Medical subject headings
- Nose Deformities, Acquired, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endonasal osteotomyProcedure or surgery
Patients will undergo median-oblique and lateral osteotomy, with conventional 2 mm guarded, straight osteotome.
Piezo assisted osteotomyDevice
Piezo is a system for cutting bone with micrometric ultrasonic piezoelectric vibrations, with varying frequency and cutting energy. The device consists of a platform with a powerful piezoelectric hand piece and employs a functional frequency between 25-29 kHz. The device is fitted with a cooling irrigation system with a 0-60 cc/min variable sterile solution flow. Specific inserts and scalpels act in a linear vibration pattern, with a spatial range between 60 and 210 microns, moved by an ultrasonic power that exceeds 5 watts, reaching up to 16 watts.
| Study group | Role | What they receive |
|---|---|---|
| Group 1A- Thick skin, endonasal osteotomy | Patients with mean nasal soft tissue envelope thickness > 4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation Receives: Procedure: Endonasal osteotomy | |
| Group 1B -Thick skin, piezo osteotomy | Patients with mean nasal soft tissue envelope thickness > 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation Receives: Device: Piezo assisted osteotomy | |
| Group 2A- Thin skin, endonasal osteotomy | Patients with mean nasal soft tissue envelope thickness <4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation Receives: Procedure: Endonasal osteotomy | |
| Group 2B- Thin skin, piezo osteotomy | Patients with mean nasal soft tissue envelope thickness < 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation Receives: Device: Piezo assisted osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10th month
the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10 th month will be done by ultrasonography at four anatomic locations; these locations are nasion, rhinion, supratip and tip
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start19 May 2023
- Primary completion19 Apr 2024 (estimated)
- Study completion19 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nasal Deformity, AcquiredStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ISIL TAYLAN CEBI, Haseki Training and Research Hospital
- Investigators
- Isil Taylan Cebi, M.D, Principal investigator, Haseki Training and Research Hospiral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094348
- Sponsor's protocol ID
- Piezo vs Endonasal osteotomy
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gode S, Ozturk A, Kismali E, Berber V, Turhal G. The Effect of Platelet-Rich Fibrin on Nasal Skin Thickness in Rhinoplasty. Facial Plast Surg. 2019 Aug;35(4):400-403. doi: 10.1055/s-0039-1693436. Epub 2019 Jul 15.
PubMed 31307096Erdur ZB, Oktem F, Inci E, Yener HM, Ustundag A. Effect of Nasal Soft-Tissue Envelope Thickness on Postoperative Healing Process Following Rhinoplasty. J Craniofac Surg. 2021 Sep 1;32(6):2193-2197. doi: 10.1097/SCS.0000000000007697.
PubMed 33867511Stenner M, Koopmann M, Rudack C. Measuring the nose in septorhinoplasty patients: ultrasonographic standard values and clinical correlations. Eur Arch Otorhinolaryngol. 2017 Feb;274(2):855-860. doi: 10.1007/s00405-016-4296-7. Epub 2016 Sep 15.
PubMed 27628964Tsikopoulos A, Tsikopoulos K, Doxani C, Vagdatli E, Meroni G, Skoulakis C, Stefanidis I, Zintzaras E. Piezoelectric or Conventional Osteotomy in Rhinoplasty? A Systematic Review and Meta-Analysis of Clinical Outcomes. ORL J Otorhinolaryngol Relat Spec. 2020;82(4):216-234. doi: 10.1159/000506707. Epub 2020 Apr 22.
PubMed 32320977Kurt Yazar S, Serin M, Rakici IT, Sirvan SS, Irmak F, Yazar M. Comparison of piezosurgery, percutaneous osteotomy, and endonasal continuous osteotomy techniques with a caprine skull model. J Plast Reconstr Aesthet Surg. 2019 Jan;72(1):107-113. doi: 10.1016/j.bjps.2018.08.025. Epub 2018 Sep 4.
PubMed 30243555
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effect of Piezo and Endonasal Osteotomy Methods on Postoperative Healing Process in Septorhinoplasty by the Ultrasonic Measurement of Nasal Skin Thickness
- ClinicalTrials.gov ID
- NCT06094348
- Acronym / sponsor ID
- Piezo vs Endonasal osteotomy
- Keywords
- rhinoplasty, edema, piezosurgery, osteotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 19 Apr 2024 (estimated)
- Study completion
- 19 Apr 2024 (estimated)
- First posted
- 23 Oct 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 goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question[s] it aims to answer are:
- In which osteotomy technique the edema is lesser?
- Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster?
Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively.
Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements)
Detailed description
The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question[s] it aims to answer are:
- In which osteotomy technique the edema is lesser?
- Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster?
18-65 years old males or females with nasal septum and/or nasal pyramid deviation and external nasal deformities who are willing to undergo open rhinoplasty procedure will be included in the study. Patients who have a history of previous rhinoplasty/septorhinoplasty procedure, abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time), use of anticoagulant drugs, chronic / inflammatory skin disease and/or chronic skin allergies, systemic diseases (hypertension, diabetes mellitus, bronchial asthma), nasal beautification procedures such as dermal fillings, using oral and/or topical (nasal skin) corticosteroids in three months preoperatively will be excluded.
Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively.
Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1A- Thick skin, endonasal osteotomy | – | Procedure: Endonasal osteotomyPatients with mean nasal soft tissue envelope thickness > 4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation |
| Group 1B -Thick skin, piezo osteotomy | – | Device: Piezo assisted osteotomyPatients with mean nasal soft tissue envelope thickness > 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation |
| Group 2A- Thin skin, endonasal osteotomy | – | Procedure: Endonasal osteotomyPatients with mean nasal soft tissue envelope thickness <4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation |
| Group 2B- Thin skin, piezo osteotomy | – | Device: Piezo assisted osteotomyPatients with mean nasal soft tissue envelope thickness < 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-65 year, males or females with nasal septum and/or nasal pyramid deviation and external nasal deformities who are willing to undergo open rhinoplasty procedure.
Key inclusion criteria (1 listed)
- nasal respiratory dysfunction with the deviation of nasal septum and/or the nasal pyramid
Key exclusion criteria (7 listed)
- previous rhinoplasty/septorhinoplasty procedure
- patients with abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time)
- use of anticoagulant drugs
- chronic / inflammatory skin disease and/or chronic skin allergies
- presence of systemic diseases (hypertension, diabetes mellitus, bronchial asthma)
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 |
|---|---|---|
| Endonasal osteotomyPatients will undergo median-oblique and lateral osteotomy, with conventional 2 mm guarded, straight osteotome. | Procedure or surgery | Group 1A- Thick skin, endonasal osteotomy, Group 2A- Thin skin, endonasal osteotomy |
| Piezo assisted osteotomyPiezo is a system for cutting bone with micrometric ultrasonic piezoelectric vibrations, with varying frequency and cutting energy. The device consists of a platform with a powerful piezoelectric hand piece and employs a functional frequency between 25-29 kHz. The device is fitted with a cooling irrigation system with a 0-60 cc/min variable sterile solution flow. Specific inserts and scalpels act in a linear vibration pattern, with a spatial range between 60 and 210 microns, moved by an ultrasonic power that exceeds 5 watts, reaching up to 16 watts. | Device | Group 1B -Thick skin, piezo osteotomy, Group 2B- Thin skin, piezo osteotomy |
Primary outcome
the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10th month
Time frame: 10 months
the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10 th month will be done by ultrasonography at four anatomic locations; these locations are nasion, rhinion, supratip and tip
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 31307096Gode S, Ozturk A, Kismali E, Berber V, Turhal G. The Effect of Platelet-Rich Fibrin on Nasal Skin Thickness in Rhinoplasty. Facial Plast Surg. 2019 Aug;35(4):400-403. doi: 10.1055/s-0039-1693436. Epub 2019 Jul 15.
- Background: PubMed 33867511Erdur ZB, Oktem F, Inci E, Yener HM, Ustundag A. Effect of Nasal Soft-Tissue Envelope Thickness on Postoperative Healing Process Following Rhinoplasty. J Craniofac Surg. 2021 Sep 1;32(6):2193-2197. doi: 10.1097/SCS.0000000000007697.
- Background: PubMed 27628964Stenner M, Koopmann M, Rudack C. Measuring the nose in septorhinoplasty patients: ultrasonographic standard values and clinical correlations. Eur Arch Otorhinolaryngol. 2017 Feb;274(2):855-860. doi: 10.1007/s00405-016-4296-7. Epub 2016 Sep 15.
- Background: PubMed 32320977Tsikopoulos A, Tsikopoulos K, Doxani C, Vagdatli E, Meroni G, Skoulakis C, Stefanidis I, Zintzaras E. Piezoelectric or Conventional Osteotomy in Rhinoplasty? A Systematic Review and Meta-Analysis of Clinical Outcomes. ORL J Otorhinolaryngol Relat Spec. 2020;82(4):216-234. doi: 10.1159/000506707. Epub 2020 Apr 22.
- Background: PubMed 30243555Kurt Yazar S, Serin M, Rakici IT, Sirvan SS, Irmak F, Yazar M. Comparison of piezosurgery, percutaneous osteotomy, and endonasal continuous osteotomy techniques with a caprine skull model. J Plast Reconstr Aesthet Surg. 2019 Jan;72(1):107-113. doi: 10.1016/j.bjps.2018.08.025. Epub 2018 Sep 4.
- Individual participant dataSharing planned: No
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.
Isil Taylan Cebi, M.D principal investigator
Haseki Training and Research Hospiral
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Deformity, Acquired and Septum; Deviation, Congenital, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Oct 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isil Taylan Cebi, M.D (00905072352256, drisiltaylan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10th month (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06094348, which also lists 5 linked publications.
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 23 Oct 2023.