Bone HealingNCT06766292
Osteogenic Potential of Schneiderian Membrane
A study testing primary intervention and open sinus lifting with xenograft only in people with Bone Healing and Sinus Membrane Osteoginicity, run by rehab soliman at 1 site in Egypt.
Trial summary
Maxillary sinus augmentation is commonly performed by creating a space below the Schneiderian membrane which is further filled using autografts, bone graft substitutes, or a combination of both to allow for new bone formation. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Healing, Sinus Membrane Osteoginicity
- What is being tested?
- primary intervention and open sinus lifting with xenograft only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Aug 2023to 3 Sep 2024
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult male/female patients above the age of 25.
- Patients with one or more teeth requiring implant supported dental restoration in atrophic maxilla (unilateral or bilateral).
- Alveolar bone height less than 4 mm at the defective site.
- Good oral hygiene.
Who cannot join
- Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
- Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
- Heavy smokers.
- Patients not indicated for an implant supported restoration at the time of enrollment (eg. active/untreated periodontal disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Radiographic and Histologic Assessment of the Osteogenic Potential of Schneiderian Membrane After Maxillary Sinus Lifting: A Randomized Controlled Clinical Trial.
Maxillary sinus augmentation is commonly performed by creating a space below the Schneiderian membrane which is further filled using autografts, bone graft substitutes, or a combination of both to allow for new bone formation. Recently, a new method called non-grafting sinus floor augmentation has been introduced as an alternative approach. This method is based on the idea of elevating the membrane and supporting it through implant insertion or the use of space-maintaining devices like titanium screws or mesh. This study was conducted to evaluate the efficacy of new bone formation after sinus floor elevation using space maintaining resorbable pins without graft material.
Read the detailed description
A randomized control trial was performed on 14 patients with partially edentulous or free end saddle posterior maxilla. The patients were divided randomly into two groups. Both groups underwent maxillary sinus open lifting procedure and augmentation using xenograft * as group A and in group B the sinus membrane was elevated and stabilized by resorbable pins** to maintain the created space stable and without grafting. The study was a double blind one (participants and out¬come assessors were blinded throughout the study).
All the surgical procedures were carried out un¬der local anesthesia using infraorbital and posterior superior alveolar nerve block with palatal infiltration. Full thickness mucoperiosteal flap was elevated to expose the lateral wall of the maxillary sinus. Then the maxil¬lary sinus floor elevation using the lateral window technique was performed. A bone window was outlined using a no. 8 diamond bur mounted on straight hand piece with copious irrigation (sterile saline solution) with cautious taken to not penetrate the sinus membrane. The process of bone removal was done through the cortical bone to reach the membrane without perforation. Complete osteotomy along the boundary of the osseous window until the Schneiderian mem-brane. The Schneiderian membrane was carefully elevated till the desired height.
xenograft Preparation: (control group/ group A)
Xenograft was mixed with saline followed by the protocol of graft packed and compacted against inferior walls and to the sides of the antrum until the new available volume created was filled. The lateral window was covered by collagen membrane before flap closure. Resorbable pins (test group/ group B):
In the study group: 2.0 mm screws were fixed to the lateral wall of the sinus above the superior osteotomy and placed buccopalatally where the schneiderian membrane was elevated and maintained. Then the soft tissue flap was readapted and sutured using continuous and interrupted sutures (3-0 resorbable vicryl)
- Conditions
- Bone Healing, Sinus Membrane Osteoginicity
- Being tested
- primary intervention, open sinus lifting with xenograft only
- Keywords
- sinus lifting, maxillary sinus augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary interventionProcedure or surgery
In the study group: 2.0 mm screws were fixed to the lateral wall of the sinus above the superior osteotomy and placed buccopalatally where the schneiderian membrane was elevated and maintained. this technique will suspends the membrane in position to allow the blood clot to organized and formation of bone.
open sinus lifting with xenograft onlyProcedure or surgery
ll Patients in this group underwent open sinus procedures to lift the sinus membrane followed by application of the xenograft as an augmentation material xenograft is used instead of autogenous bone graft to avoid the morbidity of the donor side
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | in this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft without any additives Receives: Procedure: open sinus lifting with xenograft only |
| study group | Experimental | In the study group: 2.0 mm screws were fixed to the lateral wall of the sinus above the superior osteotomy and placed buccopalatally where the schneiderian membrane was elevated and maintained. Receives: Procedure: primary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone height
will be measured using CBCT (Cone Beam Computed Tomography)
Measured: 8 months
Secondary outcomes (1)
histological analysis
will be measured using hematoxylin and eosin stains
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start27 Aug 2023
- Primary completion3 Aug 2024
- Study completion3 Sep 2024
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 Bone HealingStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- rehab soliman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, rehab soliman, Ain Shams University
- Investigators
- rehab soliman, Principal investigator, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766292
- Sponsor's protocol ID
- 672/2023
- Status last verified
- Aug 2025
- First submitted
- 5 Jan 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ElSholkamy M, Mokhtar RH, Eltayeb TM, Helwa I, Soliman RA. Clinical, radiographic and histomorphometry evaluation of the osteogenic potential of Schneiderian membrane after graftless maxillary sinus augmentation: a randomized controlled clinical trial. BMC Oral Health. 2026 Feb 19;26(1):417. doi: 10.1186/s12903-026-07772-2.
PubMed 41715114
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Histologic Assessment of the Osteogenic Potential of Schneiderian Membrane After Maxillary Sinus Lifting: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06766292
- Acronym / sponsor ID
- 672/2023
- Conditions
- Bone Healing, Sinus Membrane Osteoginicity
- Keywords
- sinus lifting, maxillary sinus augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- rehab solimanUniversity, hospital or other
- Study start
- 27 Aug 2023 (actual)
- Primary completion
- 3 Aug 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 9 Jan 2025 (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.
Maxillary sinus augmentation is commonly performed by creating a space below the Schneiderian membrane which is further filled using autografts, bone graft substitutes, or a combination of both to allow for new bone formation. Recently, a new method called non-grafting sinus floor augmentation has been introduced as an alternative approach. This method is based on the idea of elevating the membrane and supporting it through implant insertion or the use of space-maintaining devices like titanium screws or mesh. This study was conducted to evaluate the efficacy of new bone formation after sinus floor elevation using space maintaining resorbable pins without graft material.
Detailed description
A randomized control trial was performed on 14 patients with partially edentulous or free end saddle posterior maxilla. The patients were divided randomly into two groups. Both groups underwent maxillary sinus open lifting procedure and augmentation using xenograft * as group A and in group B the sinus membrane was elevated and stabilized by resorbable pins** to maintain the created space stable and without grafting. The study was a double blind one (participants and out¬come assessors were blinded throughout the study).
All the surgical procedures were carried out un¬der local anesthesia using infraorbital and posterior superior alveolar nerve block with palatal infiltration. Full thickness mucoperiosteal flap was elevated to expose the lateral wall of the maxillary sinus. Then the maxil¬lary sinus floor elevation using the lateral window technique was performed. A bone window was outlined using a no. 8 diamond bur mounted on straight hand piece with copious irrigation (sterile saline solution) with cautious taken to not penetrate the sinus membrane. The process of bone removal was done through the cortical bone to reach the membrane without perforation. Complete osteotomy along the boundary of the osseous window until the Schneiderian mem-brane. The Schneiderian membrane was carefully elevated till the desired height.
xenograft Preparation: (control group/ group A)
Xenograft was mixed with saline followed by the protocol of graft packed and compacted against inferior walls and to the sides of the antrum until the new available volume created was filled. The lateral window was covered by collagen membrane before flap closure. Resorbable pins (test group/ group B):
In the study group: 2.0 mm screws were fixed to the lateral wall of the sinus above the superior osteotomy and placed buccopalatally where the schneiderian membrane was elevated and maintained. Then the soft tissue flap was readapted and sutured using continuous and interrupted sutures (3-0 resorbable vicryl)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: open sinus lifting with xenograft onlyin this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft without any additives |
| study group | Experimental | Procedure: primary interventionIn the study group: 2.0 mm screws were fixed to the lateral wall of the sinus above the superior osteotomy and placed buccopalatally where the schneiderian membrane was elevated and maintained. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult male/female patients above the age of 25.
- Patients with one or more teeth requiring implant supported dental restoration in atrophic maxilla (unilateral or bilateral).
- Alveolar bone height less than 4 mm at the defective site.
- Good oral hygiene.
Key exclusion criteria (4 listed)
- Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
- Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
- Heavy smokers.
- Patients not indicated for an implant supported restoration at the time of enrollment (eg. active/untreated periodontal disease).
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 |
|---|---|---|
| primary interventionIn the study group: 2.0 mm screws were fixed to the lateral wall of the sinus above the superior osteotomy and placed buccopalatally where the schneiderian membrane was elevated and maintained. this technique will suspends the membrane in position to allow the blood clot to organized and formation of bone. | Procedure or surgery | study group |
| open sinus lifting with xenograft onlyll Patients in this group underwent open sinus procedures to lift the sinus membrane followed by application of the xenograft as an augmentation material xenograft is used instead of autogenous bone graft to avoid the morbidity of the donor side | Procedure or surgery | Control Group |
Primary outcome
bone height
Time frame: 8 months
will be measured using CBCT (Cone Beam Computed Tomography)
1 secondary outcome
histological analysis
Time frame: 8 months
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 11 Aug 2025.
- Derived from this study: PubMed 41715114ElSholkamy M, Mokhtar RH, Eltayeb TM, Helwa I, Soliman RA. Clinical, radiographic and histomorphometry evaluation of the osteogenic potential of Schneiderian membrane after graftless maxillary sinus augmentation: a randomized controlled clinical trial. BMC Oral Health. 2026 Feb 19;26(1):417. doi: 10.1186/s12903-026-07772-2.
- 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.
rehab soliman principal investigator
Misr International 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 primary intervention and open sinus lifting with xenograft only in people with Bone Healing and Sinus Membrane Osteoginicity, run by rehab soliman 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 4 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 11 Aug 2025. 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?
bone height (time frame: 8 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 NCT06766292, 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 11 Aug 2025.