Maxillary Sinus AugmentationPhase 4NCT04811768
Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation
A Phase 4 study testing Maxillary sinus augmentation in people with Maxillary Sinus Augmentation, run by Semmelweis University at 1 site in Hungary.
Trial summary
The aim of the present prospective randomized controlled study is to clinically and histologically investigate the safety and efficacy of bony wall repositioning compared to rotary window preparation with membrane coverage in maxillary sinus floor augmentation. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus Augmentation
- What is being tested?
- Maxillary sinus augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHungary
- Study dates
- 1 Mar 2017to 30 May 2018
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least one missing maxillary premolar or molar
- at least 7 mm crestal bone width confirmed by preoperative ConeBeam Tomography (CBCT)
- maximally 5 mm residual bone height at the sinus floor confirmed by preoperative ConeBeam Tomography (CBCT)
- full mouth plaque and bleeding scores (FMPS and FMBS) <20%
- satisfactory patient compliance (e.g. to participate in follow-up procedures)
- signed informed consent.
Who cannot join
- clinically relevant diseases (e.g.: diabetes, rheumatism cancer)
- untreated periodontitis
- systemic steroid use
- bisphosphonate use
- acute or chronic inflammatory processes
- previous endoscopic sinus surgery
Show all 10Show fewer
- previous sinus floor elevation
- GBR-treatment at the study site
- GTR-treatment at the study site
- tooth removal within 6 weeks prior to surgery
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University Department of Periodontology
Budapest, 1088
About this study
Official title: Comparative Clinical and Histological Investigation of Graft Integration Following Piezosurgically Retrieved Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation - Prospective Randomized Controlled Study
The aim of the present prospective randomized controlled study is to clinically and histologically investigate the safety and efficacy of bony wall repositioning compared to rotary window preparation with membrane coverage in maxillary sinus floor augmentation.
Read the detailed description
40 patients were randomly divided in two study groups after radiological and clinical evaluation. Both groups received bone grafting by a xenogeneic bone substitute (BSM, cerabone, botiss biomaterials GmbH, Zossen, Germany) using the lateral approach. In the bony wall group (BW), following piezosurgery the retrieved bony wall was repositioned. In the collagen membrane group (CM), the lateral window was created by rotary instruments, covered via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany). After 6 months, biopsies were taken to analyze both approaches in terms of new bone formation. Duration of treatment, the number of perforations, postoperative patient discomfort were registered. Established histopathological analysis and histomorphometrical measurements to analyze the tissue reactions and the tissue distribution, i.e., the fractions of newly formed bone tissue (NB), of remaining bone substitute material (BSM) and connective tissue (CT), were conducted.
- Conditions
- Maxillary Sinus Augmentation
- Being tested
- Maxillary sinus augmentation
- Keywords
- maxillary sinus, xenogeneic graft, collagen membrane, lateral bony wall repositioning, piezoelectric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary sinus augmentationProcedure or surgery
Also called Sinus lift
The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization.
| Study group | Role | What they receive |
|---|---|---|
| Bony wall group | Experimental | In the bony wall group, following piezosurgery the retrieved bony wall was repositioned. Receives: Procedure: Maxillary sinus augmentation |
| Collagen membrane group | Experimental | In the collagen membrane group, the lateral window was created by rotary instruments, covered via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany). Receives: Procedure: Maxillary sinus augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of surgery
Recorded in minutes
Measured: During smaxillary sinus augmentation
Secondary outcomes (7)
Duration of lateral window preparation
Recorded in minutes
Measured: During maxillary sinus augmentation
Duration of mucosa preparation
Recorded in minutes
Measured: During maxillary sinus augmentation
Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)
Measurement of patient discomfort
Measured: 12 hours postoperatively
Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)
Measurement of patient discomfort
Measured: 1 day postoperatively
Postoperative Edema Score
Measurement of swelling
Measured: 2 days postoperatively
Postoperative Edema Score
Measurement of swelling
Measured: 3 days postoperatively
Histomorphometrical analysis
Percentage of newly formed bone, bone substitute and connective tissue
Measured: Following reentry 6 months after maxillary sinus augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Mar 2017
- Primary completion30 May 2018
- Study completion30 May 2018
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 40 patients underwent sinus floor augmentation - 20 patients treated by bony wall repositioning, 20 patients treated by collagen membrane coverage
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- NSK Europe GmbH, Botiss Medical AG, Institut Straumann AG, Dicomlab Kft., Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006), Excellence Program of the Ministry for Innovation and Technology in Hungary
- Responsible party
- Principal investigator, Balint Molnar, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811768
- Sponsor's protocol ID
- Sinus-Semmelweis-Perio
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Molnar B, Jung AK, Papp Z, Martin A, Orban K, Prohl A, Jung O, Barbeck M, Windisch P. Comparative analysis of lateral maxillary sinus augmentation with a xenogeneic bone substitute material in combination with piezosurgical preparation and bony wall repositioning or rotary instrumentation and membrane coverage: a prospective randomized clinical and histological study. Clin Oral Investig. 2022 Aug;26(8):5261-5272. doi: 10.1007/s00784-022-04494-x. Epub 2022 May 20.
PubMed 35593928
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical and Histological Investigation of Graft Integration Following Piezosurgically Retrieved Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation - Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04811768
- Acronym / sponsor ID
- Sinus-Semmelweis-Perio
- Conditions
- Maxillary Sinus Augmentation
- Keywords
- maxillary sinus, xenogeneic graft, collagen membrane, lateral bony wall repositioning, piezoelectric surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- NSK Europe GmbH, Botiss Medical AG, Institut Straumann AG, Dicomlab Kft., Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006), Excellence Program of the Ministry for Innovation and Technology in Hungary
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 23 Mar 2021 (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 present prospective randomized controlled study is to clinically and histologically investigate the safety and efficacy of bony wall repositioning compared to rotary window preparation with membrane coverage in maxillary sinus floor augmentation.
Detailed description
40 patients were randomly divided in two study groups after radiological and clinical evaluation. Both groups received bone grafting by a xenogeneic bone substitute (BSM, cerabone, botiss biomaterials GmbH, Zossen, Germany) using the lateral approach. In the bony wall group (BW), following piezosurgery the retrieved bony wall was repositioned. In the collagen membrane group (CM), the lateral window was created by rotary instruments, covered via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany). After 6 months, biopsies were taken to analyze both approaches in terms of new bone formation. Duration of treatment, the number of perforations, postoperative patient discomfort were registered. Established histopathological analysis and histomorphometrical measurements to analyze the tissue reactions and the tissue distribution, i.e., the fractions of newly formed bone tissue (NB), of remaining bone substitute material (BSM) and connective tissue (CT), were conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 40 patients underwent sinus floor augmentation - 20 patients treated by bony wall repositioning, 20 patients treated by collagen membrane coverage
| Arm | Type | Receives |
|---|---|---|
| Bony wall group | Experimental | Procedure: Maxillary sinus augmentationIn the bony wall group, following piezosurgery the retrieved bony wall was repositioned. |
| Collagen membrane group | Experimental | Procedure: Maxillary sinus augmentationIn the collagen membrane group, the lateral window was created by rotary instruments, covered via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least one missing maxillary premolar or molar
- at least 7 mm crestal bone width confirmed by preoperative ConeBeam Tomography (CBCT)
- maximally 5 mm residual bone height at the sinus floor confirmed by preoperative ConeBeam Tomography (CBCT)
- full mouth plaque and bleeding scores (FMPS and FMBS) <20%
- satisfactory patient compliance (e.g. to participate in follow-up procedures)
Key exclusion criteria (10 listed)
- clinically relevant diseases (e.g.: diabetes, rheumatism cancer)
- untreated periodontitis
- systemic steroid use
- bisphosphonate use
- acute or chronic inflammatory processes
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 augmentationAlso: Sinus liftThe surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization. | Procedure or surgery | Bony wall group, Collagen membrane group |
Primary outcome
Duration of surgery
Time frame: During smaxillary sinus augmentation
Recorded in minutes
7 secondary outcomes
Duration of lateral window preparation
Time frame: During maxillary sinus augmentation
Duration of mucosa preparation
Time frame: During maxillary sinus augmentation
Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)
Time frame: 12 hours postoperatively
Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)
Time frame: 1 day postoperatively
Postoperative Edema Score
Time frame: 2 days postoperatively
Postoperative Edema Score
Time frame: 3 days postoperatively
Histomorphometrical analysis
Time frame: Following reentry 6 months after maxillary sinus augmentation
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 23 Mar 2021.
- Derived from this study: PubMed 35593928Molnar B, Jung AK, Papp Z, Martin A, Orban K, Prohl A, Jung O, Barbeck M, Windisch P. Comparative analysis of lateral maxillary sinus augmentation with a xenogeneic bone substitute material in combination with piezosurgical preparation and bony wall repositioning or rotary instrumentation and membrane coverage: a prospective randomized clinical and histological study. Clin Oral Investig. 2022 Aug;26(8):5261-5272. doi: 10.1007/s00784-022-04494-x. Epub 2022 May 20.
- 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 Phase 4 study testing Maxillary sinus augmentation in people with Maxillary Sinus Augmentation, run by Semmelweis University at 1 site in Hungary.
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 10 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 23 Mar 2021. 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 Hungary. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Duration of surgery (time frame: During smaxillary sinus augmentation). 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 NCT04811768, 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 23 Mar 2021.