Maxillary Sinus AugmentationNCT06601816
Maxillary Sinus Elevation and Perioperative Complications
A study testing maxillary sinus lift with reamer, maxillary sinus lift with piezzo and maxillary sinus lift with conventional burr in people with Maxillary Sinus Augmentation, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of various external sinus lifting techniques on patient comfort and perioperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Sinus Augmentation
- What is being tested?
- maxillary sinus lift with reamer, maxillary sinus lift with piezzo and maxillary sinus lift with conventional burr
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jun 2023to 14 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe resorption or sinus pneumatization in the posterior maxilla that prevents standard implant treatment; class V or VI according to Cawood and Howell classification, patients with residual bone height less than 6 mm
- Patients over 18 years of age
- Patients without a history of reconstructive pre-prosthetic surgery or previous implant surgery
- Patients with partial edentulism who have applied to our center for implant treatment and need sinus lifting
- Patients with cone beam computed tomography (CBCT) taken within the last 1 month
Who cannot join
- Patients with a history of systemic diseases (hematologic, neurologic, etc.) that may be contraindicated surgery
- Patients who are pregnant or in lactation period
- Patients with a history of immune system disorders and substance abuse
- Patients with a history of radiotherapy in the head and neck region
- Patients with existing maxillary sinus pathology or who have undergone surgery
- Patients who smoke \>10 cigarettes per day
Show all 9Show fewer
- Patients using antibiotics or steroids in the 30 days before surgery
- Uncooperative patients who do not comply with the study protocol or follow-up regimen
- Patients with perforation of the Schneiderian membrane
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Sinus Lifting Techniques Performed with Piezosurgery and a Surgical Guide, a Specially Designed Drill, and Conventional Drills in Terms Complications and Quality of Life
This study aims to investigate the effects of various external sinus lifting techniques on patient comfort and perioperative complications.
Read the detailed description
Patients who met the inclusion criteria and were admitted for posterior maxilla rehabilitation participated in this prospective, randomized, controlled clinical trial. The three methods used to lift the sinuses were randomized: piezosurgery using a surgical guide, a drill specifically made for lateral sinus lift, and traditional drills. Recorded were the duration of the procedure, accessibility, and intraoperative complications. During the first week following surgery, analgesic intake and pain using a visual analog scale (VAS) were assessed assessed. Preoperatively and on the second and seventh postoperative days, edema was assessed. Preoperatively and on the seventh postoperative day, the patient\'s quality of life using the OHIP-14 questionnaire, experiences, and expectations were evaluated.
- Conditions
- Maxillary Sinus Augmentation
- Being tested
- maxillary sinus lift with reamer, maxillary sinus lift with piezzo, maxillary sinus lift with conventional burr
- Keywords
- Sinus floor augmentation, computer-aided design, piezosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary sinus lift with reamerProcedure or surgery
Lateral window created with specially designed burs for lateral sinus lift
maxillary sinus lift with piezzoProcedure or surgery
lateral window was created using piezo surgery and surgical guide
maxillary sinus lift with conventional burrProcedure or surgery
the lateral window was created with conventional rotary instrument burs
| Study group | Role | What they receive |
|---|---|---|
| Reamer Group | Active comparator | The group in which the lateral window was created with conventional rotary instrument burs Receives: Procedure: maxillary sinus lift with reamer |
| Piezo surgery with Surgical Guide Group | Active comparator | The group in which the lateral window was created using piezo surgery and surgical guide Receives: Procedure: maxillary sinus lift with piezzo |
| Conventional Group | Active comparator | The group in which the lateral window was created with conventional rotary instrument burs Receives: Procedure: maxillary sinus lift with conventional burr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation Time
The time from the osteotomy of the sinus window to completation of membrane elevation
Measured: from the osteotomy of the sinus window to completation of membrane elevation
Secondary outcomes (6)
Patient Experience
Patients asked to rate their postoperative experience with a 3-point scale (0, my expectation and experience were the same/similar; 1, my experience was better than my expectation; 2, my experience was worse than my expectation)
Measured: 7th postoperative day
Pain
intensity of pain experienced by patients assessed using a 10-cm Visual Analogue Scale (VAS)
Measured: from 6 hours to postoperative 7 days
Analgesic Consumption
need for analgesics
Measured: from 6 hours to 7 days postoperatively
Edema
Swelling after surgery measurements collected of a anatomical locations on the face that served as reference points. Reference points included the tragus, alare, lateral corner of the eye, gonion, soft tissue pogonion, and external corner of the mouth. The average of each measurement was used to calculate the edema level.
Measured: on the 2nd and 7th days
Quality of Life
The OHIP-14 used to measure quality of life. Scores ranged from 0 (no impact) to 56 (all oral health concerns encountered extremely frequently). It was scored as follows: Never (0 points); Seldom (1 point); Sometimes (2 points); Frequently (3 points); and Very frequently (4 points).
Measured: preoperatively and on postoperative day 7
Surgeon;s Comfort
The comfort of the access to the operation site evaluated by the surgeon on a 4-point scale (0, very poor visibility; 1, fair visibility; 2, good visibility; 3, excellent visibility)
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start12 Jun 2023
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary Sinus AugmentationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The three methods used to lift the sinuses were randomized: piezosurgery using a surgical guide, a drill specifically made for lateral sinus lift, and traditional drills.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Melih Omezli, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601816
- Sponsor's protocol ID
- B-2323
- Other IDs
- 23-AKD-48
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozyalcin MS, Omezli MM, Torul D. Effects of Different External Sinus Lifting Techniques on Perioperative Complications and Patient Comfort. Clin Implant Dent Relat Res. 2025 Jun;27(3):e70044. doi: 10.1111/cid.70044.
PubMed 40320286
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sinus Lifting Techniques Performed with Piezosurgery and a Surgical Guide, a Specially Designed Drill, and Conventional Drills in Terms Complications and Quality of Life
- ClinicalTrials.gov ID
- NCT06601816
- Acronym / sponsor ID
- B-2323
- Conditions
- Maxillary Sinus Augmentation
- Keywords
- Sinus floor augmentation, computer-aided design, piezosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 19 Sep 2024 (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.
This study aims to investigate the effects of various external sinus lifting techniques on patient comfort and perioperative complications.
Detailed description
Patients who met the inclusion criteria and were admitted for posterior maxilla rehabilitation participated in this prospective, randomized, controlled clinical trial. The three methods used to lift the sinuses were randomized: piezosurgery using a surgical guide, a drill specifically made for lateral sinus lift, and traditional drills. Recorded were the duration of the procedure, accessibility, and intraoperative complications. During the first week following surgery, analgesic intake and pain using a visual analog scale (VAS) were assessed assessed. Preoperatively and on the second and seventh postoperative days, edema was assessed. Preoperatively and on the seventh postoperative day, the patient\'s quality of life using the OHIP-14 questionnaire, experiences, and expectations were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The three methods used to lift the sinuses were randomized: piezosurgery using a surgical guide, a drill specifically made for lateral sinus lift, and traditional drills.
| Arm | Type | Receives |
|---|---|---|
| Reamer Group | Active comparator | Procedure: maxillary sinus lift with reamerThe group in which the lateral window was created with conventional rotary instrument burs |
| Piezo surgery with Surgical Guide Group | Active comparator | Procedure: maxillary sinus lift with piezzoThe group in which the lateral window was created using piezo surgery and surgical guide |
| Conventional Group | Active comparator | Procedure: maxillary sinus lift with conventional burrThe group in which the lateral window was created with conventional rotary instrument burs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Severe resorption or sinus pneumatization in the posterior maxilla that prevents standard implant treatment; class V or VI according to Cawood and Howell classification, patients with residual bone height less than 6 mm
- Patients over 18 years of age
- Patients without a history of reconstructive pre-prosthetic surgery or previous implant surgery
- Patients with partial edentulism who have applied to our center for implant treatment and need sinus lifting
- Patients with cone beam computed tomography (CBCT) taken within the last 1 month
Key exclusion criteria (9 listed)
- Patients with a history of systemic diseases (hematologic, neurologic, etc.) that may be contraindicated surgery
- Patients who are pregnant or in lactation period
- Patients with a history of immune system disorders and substance abuse
- Patients with a history of radiotherapy in the head and neck region
- Patients with existing maxillary sinus pathology or who have undergone 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 |
|---|---|---|
| maxillary sinus lift with reamerLateral window created with specially designed burs for lateral sinus lift | Procedure or surgery | Reamer Group |
| maxillary sinus lift with piezzolateral window was created using piezo surgery and surgical guide | Procedure or surgery | Piezo surgery with Surgical Guide Group |
| maxillary sinus lift with conventional burrthe lateral window was created with conventional rotary instrument burs | Procedure or surgery | Conventional Group |
Primary outcome
Operation Time
Time frame: from the osteotomy of the sinus window to completation of membrane elevation
The time from the osteotomy of the sinus window to completation of membrane elevation
6 secondary outcomes
Patient Experience
Time frame: 7th postoperative day
Pain
Time frame: from 6 hours to postoperative 7 days
Analgesic Consumption
Time frame: from 6 hours to 7 days postoperatively
Edema
Time frame: on the 2nd and 7th days
Quality of Life
Time frame: preoperatively and on postoperative day 7
Surgeon;s Comfort
Time frame: Immediately after surgery
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 19 Sep 2024.
- Derived from this study: PubMed 40320286Ozyalcin MS, Omezli MM, Torul D. Effects of Different External Sinus Lifting Techniques on Perioperative Complications and Patient Comfort. Clin Implant Dent Relat Res. 2025 Jun;27(3):e70044. doi: 10.1111/cid.70044.
- Individual participant dataSharing planned: No
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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 maxillary sinus lift with reamer, maxillary sinus lift with piezzo and maxillary sinus lift with conventional burr in people with Maxillary Sinus Augmentation, run by Ordu University 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 5 inclusion and 9 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 19 Sep 2024. 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?
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?
Operation Time (time frame: from the osteotomy of the sinus window to completation of membrane elevation). 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 NCT06601816, which also lists 1 linked publication.
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 19 Sep 2024.