Alveolar Bone LossNCT06533397
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
A study testing Sinus floor elevation (SFE), preoperative cone beam computed tomography (CBCT) and postoperative CBCT in people with Alveolar Bone Loss and Edentulism Nos, run by Semmelweis University at 1 site in Hungary.
Trial summary
Pneumatization of the maxillary sinus may lead to insufficient bone volume for dental implant placement in the edentulous posterior maxilla. Sinus floor elevation (SFE) surgery with the lateral window technique is a safe and predictable surgical intervention to restore bone height in the maxillary premolar and molar… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Loss, Edentulism Nos
- What is being tested?
- Sinus floor elevation (SFE), preoperative cone beam computed tomography (CBCT) and postoperative CBCT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHungary
- Study dates
- 24 Aug 2024to Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients over the age of 18 years,
- Patients who need dental implant-borne prostheses,
- Patients with insufficient bone height in the posterior maxilla due to sinus pneumatization.
Who cannot join
- .• Patients who had major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV),
- psychiatric contraindications,
- patients on medication interfering with bone metabolism, including steroid therapy and antiresorptive medication,
- radiation to the head or neck region within the previous five years,
- localized periapical disease, odontogenic and nonodontogenic cysts, and maxillary sinusitis,
- evidence of uncontrolled periodontal disease,
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- Alcohol Use Disorder defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5),
- recreational drug abuse,
- heavy smoking (>10 cigarettes/day),
- diseases of the oral mucosa, including blisters and ulcers, i.e.: red and white lesions, pigmented lesions, benign tumors of the oral cavity, and oral cancer. Leukoplakia, Erythroplakia, Precancerous lesions, Oral squamous cell carcinoma and malign tumors of the soft and hard tissues, Oral candidiasis, Oral lichen planus, Psoriasis, Pemphigus, and Pemphigoid.
- pregnancy or nursing,
- poor oral hygiene
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University Department of Public Dental Health
Budapest, Budapest, 1088
Márton Kivovics, DMD MSc PhD, 003614591500 ext. 60732, kivovics.marton@semmelweis.hu
About this study
Pneumatization of the maxillary sinus may lead to insufficient bone volume for dental implant placement in the edentulous posterior maxilla. Sinus floor elevation (SFE) surgery with the lateral window technique is a safe and predictable surgical intervention to restore bone height in the maxillary premolar and molar areas. According to the literature, several bone graft materials may be successfully applied for SFE surgery. There is a lack of evidence regarding the application of biphasic calcium sulfate (BCS) for SFE. The healing period following staged SFE is 2-9 months.
The aim of this study is:
- to evaluate the success of SFE surgery using BCS as graft material,
- to compare the microarchitecture of the augmented bone depending on the healing period,
- to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.
- Conditions
- Alveolar Bone Loss, Edentulism Nos
- Being tested
- Sinus floor elevation (SFE), preoperative cone beam computed tomography (CBCT), postoperative CBCT, bone core biopsy, dental implant placement
- Keywords
- bone graft material, biphasic calcium sulfate, sinus floor elevation, sinus lift, maxillary sinus augmentation, microcomputed tomography, cone beam computed tomography, histology, histomorphometry, dental implant
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus floor elevation (SFE)Procedure or surgery
Also called sinus lift surgery, maxillary sinus augmentation
Patients rinse with 0.2% chlorhexidine solution for one minute before surgery. Under local anesthesia, a mucoperiosteal flap is raised from a midcrestal incision and two relieving incisions. Lateral window osteotomies are carried out using diamond burs. The Schneiderian membrane is carefully elevated and the synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) (2-3 cm3) is packed in the defect with light force. The buccal flap is then mobilized to allow tension-free primary closure. The margins are stabilized with single interrupted sutures. Antibiotics (1 g amoxicillin-clavulanate twice a day for 5 days, or in case of side effects or known allergy to penicillin, 300 mg clindamycin 4 times a day for 4 days), anti-inflammatory drugs (50 mg diclofenac 3 times a day for 3 days), and chlorhexidine mouthwash (twice a day for 21 days from the first day after surgery) are prescribed. Suture removal takes place after 10 days.
preoperative cone beam computed tomography (CBCT)Diagnostic test
A CBCT scan is performed before SFE surgery to evaluate the anatomy and pathologies of the maxillary sinus.
postoperative CBCTDiagnostic test
A CBCT scan is performed following the 3- or 6-month-long healing period after SFE to evaluate the anatomy and healing of the augmented bone and the maxillary sinus.
bone core biopsyDiagnostic test
At the time of dental implant placement, the first step of the implant bed preparation is performed using a trephine drill to harvest a bone core biopsy sample from the augmented bone. The biopsy sample is harvested from the implant bed, this way the patient is spared of excess surgical burden as this bone would be removed even if no biopsy sample was harvested during dental implant placement. The bone core biopsy samples are subjected to histomorphometric and microCT analysis.
dental implant placementProcedure or surgery
Following the 3- or 6-month-long healing period following SFE, dental implants are placed non-submerged in the augmented bone under local anesthesia.
fixed dental prosthesis (FDP) fabricationProcedure or surgery
3 months after dental implant placement, fixed dental prostheses are delivered on the dental implants.
bone graftingDevice
A synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) is used during SFE.
| Study group | Role | What they receive |
|---|---|---|
| 3-month healing period | Experimental | Staged SFE is performed; following a 3-month-long healing period, bone core biopsy samples are harvested from the augmented bone, and dental implants are placed. Receives: Procedure: Sinus floor elevation (SFE); Diagnostic Test: preoperative cone beam computed tomography (CBCT); Diagnostic Test: postoperative CBCT; Diagnostic Test: bone core biopsy; Procedure: dental implant placement; Procedure: fixed dental prosthesis (FDP) fabrication; Device: bone grafting |
| 6-month healing period | Experimental | Staged SFE is performed; following a 6-month-long healing period, bone core biopsy samples are harvested from the augmented bone, and dental implants are placed. Receives: Procedure: Sinus floor elevation (SFE); Diagnostic Test: preoperative cone beam computed tomography (CBCT); Diagnostic Test: postoperative CBCT; Diagnostic Test: bone core biopsy; Procedure: dental implant placement; Procedure: fixed dental prosthesis (FDP) fabrication; Device: bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the SFE
The SFE surgery is successful if no inflammatory complications occur in the 3- or 6-month-long healing period and the bone volume is sufficient for dental implant placement.
Measured: 3 or 6 months
Success of the dental implants
According to The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference.
Success (optimum health)
- No pain or tenderness upon function
- 0 mobility
- less than 2 mm radiographic bone loss from initial surgery
- No exudates in the patient's history
II. Satisfactory survival
- No pain on function
- 0 mobility
- 2-4 mm radiographic bone loss
- No exudates in the patient's history
III. Compromised survival
- May have sensitivity on function
- No mobility
- Radiographic bone loss of more than 4 mm (less than1/2 of the length of the implant body)
- Probing depth more than 7 mm
- May have exudates in the patient's history
IV. Failure (clinical or absolute failure)
Any of the following:
- Pain on function
- Mobility
- Radiographic bone loss of more than 1/2 length of the implant
- Uncontrolled exudate
- Implant no longer in mouth
Measured: 5 years
Success of the implant borne prostheses
Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
Measured: 5 years
Secondary outcomes (11)
Hisomorphometry: Percent of residual bone graft particles
The percentage of residual bone graft particle-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)
Measured: 3-6 months
Hisomorphometry: Percent of newly formed bone
The percentage of newly formed bone-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)
Measured: 3-6 months
Hisomorphometry: Percent of bone marrow
The percentage of bone marrow-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)
Measured: 3-6 months
Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples.
Relative volume of calcified tissue in the selected volume. Unit: none
Measured: 3-6 months
Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples.
Ratio of the segmented bone surface to the total volume in the region of interest. Unit: 1/mm
Measured: 3-6 months
Value of the trabecular thickness (Tb.Th.), calculated from the microCT reconstructions of the bone core biopsy samples.
Mean thickness of the trabeculae, assessed using direct 3D methods. Unit: mm
Measured: 3-6 months
Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples.
Mean distance between the trabeculae, assessed using direct 3D methods. Unit: mm
Measured: 3-6 months
Value of the trabecular bone pattern factor (Tb.Pf), calculated from the microCT reconstructions of the bone core biopsy samples.
Indicator of the relation between convex and concave elements in the trabecular bone structure. Tb.Pf <0 when the trabecular bone is honeycomb-like and increases as the trabecular bone acquires a rod-like structure. Unit: none
Measured: 3-6 months
Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples.
The estimator of the plate- versus rod-like characteristic of the trabecular bone structure, 0 for perfect plates, 3 for perfect rods, and 4 for perfect spheres. Unit: none
Measured: 3-6 months
Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples.
Percent porosity is the volume of pores as a percent of the total volume of interest (VOI). Unit: percent (%)
Measured: 3-6 months
Value of the Connectivity (Conn.), calculated from the microCT reconstructions of the bone core biopsy samples.
One useful and fast algorithm for calculating the Euler connectivity in 3D is the "Conneulor". It measures what might be called "redundant connectivity", the degree to which parts of the object are multiply connected. It is a measure of how many connections in a structure can be severed before the structure falls into two separate pieces. Unit: none.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start24 Aug 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Semmelweis 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
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marton Kivovics, Semmelweis University
- Investigators
- Márton Kivovics, DMD,MSD,PHD, Principal investigator, Department of Public Dental Health, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533397
- Sponsor's protocol ID
- SEDCD44
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
- ClinicalTrials.gov ID
- NCT06533397
- Acronym / sponsor ID
- SEDCD44
- Conditions
- Alveolar Bone Loss, Edentulism Nos
- Keywords
- bone graft material, biphasic calcium sulfate, sinus floor elevation, sinus lift, maxillary sinus augmentation, microcomputed tomography, cone beam computed tomography, histology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 24 Aug 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 1 Aug 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.
Pneumatization of the maxillary sinus may lead to insufficient bone volume for dental implant placement in the edentulous posterior maxilla. Sinus floor elevation (SFE) surgery with the lateral window technique is a safe and predictable surgical intervention to restore bone height in the maxillary premolar and molar areas. According to the literature, several bone graft materials may be successfully applied for SFE surgery. There is a lack of evidence regarding the application of biphasic calcium sulfate (BCS) for SFE. The healing period following staged SFE is 2-9 months.
The aim of this study is:
- to evaluate the success of SFE surgery using BCS as graft material,
- to compare the microarchitecture of the augmented bone depending on the healing period,
- to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-month healing period | Experimental | Procedure: Sinus floor elevation (SFE), Diagnostic Test: preoperative cone beam computed tomography (CBCT), Diagnostic Test: postoperative CBCT, Diagnostic Test: bone core biopsy, Procedure: dental implant placement, Procedure: fixed dental prosthesis (FDP) fabrication, Device: bone graftingStaged SFE is performed; following a 3-month-long healing period, bone core biopsy samples are harvested from the augmented bone, and dental implants are placed. |
| 6-month healing period | Experimental | Procedure: Sinus floor elevation (SFE), Diagnostic Test: preoperative cone beam computed tomography (CBCT), Diagnostic Test: postoperative CBCT, Diagnostic Test: bone core biopsy, Procedure: dental implant placement, Procedure: fixed dental prosthesis (FDP) fabrication, Device: bone graftingStaged SFE is performed; following a 6-month-long healing period, bone core biopsy samples are harvested from the augmented bone, and dental implants are placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 18 years,
- Patients who need dental implant-borne prostheses,
- Patients with insufficient bone height in the posterior maxilla due to sinus pneumatization.
Key exclusion criteria (12 listed)
- .• Patients who had major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV),
- psychiatric contraindications,
- patients on medication interfering with bone metabolism, including steroid therapy and antiresorptive medication,
- radiation to the head or neck region within the previous five years,
- localized periapical disease, odontogenic and nonodontogenic cysts, and maxillary sinusitis,
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 |
|---|---|---|
| Sinus floor elevation (SFE)Also: sinus lift surgery, maxillary sinus augmentationPatients rinse with 0.2% chlorhexidine solution for one minute before surgery. Under local anesthesia, a mucoperiosteal flap is raised from a midcrestal incision and two relieving incisions. Lateral window osteotomies are carried out using diamond burs. The Schneiderian membrane is carefully elevated and the synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) (2-3 cm3) is packed in the defect with light force. The buccal flap is then mobilized to allow tension-free primary closure. The margins are stabilized with single interrupted sutures. Antibiotics (1 g amoxicillin-clavulanate twice a day for 5 days, or in case of side effects or known allergy to penicillin, 300 mg clindamycin 4 times a day for 4 days), anti-inflammatory drugs (50 mg diclofenac 3 times a day for 3 days), and chlorhexidine mouthwash (twice a day for 21 days from the first day after surgery) are prescribed. Suture removal takes place after 10 days. | Procedure or surgery | 3-month healing period, 6-month healing period |
| preoperative cone beam computed tomography (CBCT)A CBCT scan is performed before SFE surgery to evaluate the anatomy and pathologies of the maxillary sinus. | Diagnostic test | 3-month healing period, 6-month healing period |
| postoperative CBCTA CBCT scan is performed following the 3- or 6-month-long healing period after SFE to evaluate the anatomy and healing of the augmented bone and the maxillary sinus. | Diagnostic test | 3-month healing period, 6-month healing period |
| bone core biopsyAt the time of dental implant placement, the first step of the implant bed preparation is performed using a trephine drill to harvest a bone core biopsy sample from the augmented bone. The biopsy sample is harvested from the implant bed, this way the patient is spared of excess surgical burden as this bone would be removed even if no biopsy sample was harvested during dental implant placement. The bone core biopsy samples are subjected to histomorphometric and microCT analysis. | Diagnostic test | 3-month healing period, 6-month healing period |
| dental implant placementFollowing the 3- or 6-month-long healing period following SFE, dental implants are placed non-submerged in the augmented bone under local anesthesia. | Procedure or surgery | 3-month healing period, 6-month healing period |
| fixed dental prosthesis (FDP) fabrication3 months after dental implant placement, fixed dental prostheses are delivered on the dental implants. | Procedure or surgery | 3-month healing period, 6-month healing period |
| bone graftingA synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) is used during SFE. | Device | 3-month healing period, 6-month healing period |
Primary outcome
Success of the SFE
Time frame: 3 or 6 months
The SFE surgery is successful if no inflammatory complications occur in the 3- or 6-month-long healing period and the bone volume is sufficient for dental implant placement.
Success of the dental implants
Time frame: 5 years
According to The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Success (optimum health) 1. No pain or tenderness upon function 2. 0 mobility 3. less than 2 mm radiographic bone loss from initial surgery 4. No exudates in the patient's history II. Satisfactory survival 1. No pain on function 2. 0 mobility 3. 2-4 mm radiographic bone loss 4. No exudates in the patient's history III. Compromised survival 1. May have sensitivity on function 2. No mobility 3. Radiographic bone loss of more than 4 mm (less than1/2 of the length of the implant body) 4. Probing depth more than 7 mm 5. May have exudates in the patient's history IV. Failure (clinical or absolute failure) Any of the following: 1. Pain on function 2. Mobility 3. Radiographic bone loss of more than 1/2 length of the implant 4. Uncontrolled exudate 5. Implant no longer in mouth
Success of the implant borne prostheses
Time frame: 5 years
Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
11 secondary outcomes
Hisomorphometry: Percent of residual bone graft particles
Time frame: 3-6 months
Hisomorphometry: Percent of newly formed bone
Time frame: 3-6 months
Hisomorphometry: Percent of bone marrow
Time frame: 3-6 months
Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 months
Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 months
Value of the trabecular thickness (Tb.Th.), calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 months
Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 months
Value of the trabecular bone pattern factor (Tb.Pf), calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 months
Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 months
Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 months
Value of the Connectivity (Conn.), calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- 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.
Márton Kivovics, DMD,MSD,PHD principal investigator
Department of Public Dental Health, Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinus floor elevation (SFE), preoperative cone beam computed tomography (CBCT) and postoperative CBCT in people with Alveolar Bone Loss and Edentulism Nos, 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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Márton Kivovics, DMD,MSD,PHD (003614591500 ext. 60732, kivovics.marton@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of the SFE (time frame: 3 or 6 months). The study lists 3 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 28 Oct 2026.