Sinus PerforationNCT07348094
Guided Lateral Sinus Lifting Using Autologous Serum Albumin/Platelet-Rich Fibrin
A study testing Guided Lateral Sinus Lifting with bone graft, Guided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich Fibrin and Guided Lateral Sinus Lifting with sticky bone in people with Sinus Perforation and Dental Implant Failure Nos, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This research aimed to evaluate the effect of an autologous Alb-PRF on bone regeneration after lateral sinus lifting via 3D volumetric analysis. The null hypothesis of this research was that there would be no significant difference between the group that would be treated by lateral sinus lift and Alb-PRF application… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus Perforation, Dental Implant Failure Nos
- What is being tested?
- Guided Lateral Sinus Lifting with bone graft, Guided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich Fibrin and Guided Lateral Sinus Lifting with sticky bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jan 2026to 15 Feb 2027
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females ≥18 years of age.
- ASA I and ASA II.
- Patients having partial edentulism in the posterior region of the maxilla.
- Edentulous sites consist of native non augmented bone.
- Horizontal ridge dimension minimum of 5mm
- The vertical ridge dimension 3-6 mm.
- Bone quality of D2 or D3.
- Enough inter-arch distance.
Who cannot join
- - Patients with uncontrolled systemic diseases.
- History of chronic maxillary sinus pathology.
- Heavy smokers or patients with 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.
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry, kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 214312
walid elamrousy, +201005724781, Waled_Hammed@den.kfs.edu.eg
About this study
Official title: Computer-Guided Lateral Sinus Floor Elevation Using Autologous Serum Albumin/Platelet Rich Fibrin Combined With Serum Albumin Membrane: A Randomized Clinical Study
This research aimed to evaluate the effect of an autologous Alb-PRF on bone regeneration after lateral sinus lifting via 3D volumetric analysis. The null hypothesis of this research was that there would be no significant difference between the group that would be treated by lateral sinus lift and Alb-PRF application and that would be treated by lateral sinus lift with bone graft for bone regeneration.
Read the detailed description
Sinus floor augmentation became a widely accepted surgical procedure to improve the amount of bone volume before implant placement. According to the guided bone regeneration principles, in the sinus lift procedure, bone graft was demonstrated to act as space holder under the elevated sinus membrane. The osteogenic source for the bone healing derives from two different anatomic sites: the basal bone of the sinus cavity and the periosteum represented as basal cell layer of the Schneiderian membrane.
Proper and accurate design and location of the lateral side window is necessary to facilitate the sinus lifting process and help the surgeon to successfully lift the sinus membrane. In addition, direct visualization helps in better packing of the entire graft space, which is essential to provide primary stability for the simultaneous insertion of the implants with the sinus elevation procedure.
The application of digital technology has proven to be a valuable tool for diagnosis and treatment planning. Data obtained from CBCT scans, digital oral scans, and facial scans can be integrated and manipulated using special computer software, providing surgeons with an interactive interface to perform virtual surgery planning before the actual surgery.
The precision of stereolithographic guides may mitigate risks associated with anatomical variations in atrophic maxillae, potentially reducing membrane perforation and optimizing lateral window osteotomy and implant placement accuracy which are key factors this study evaluates.
Recently, the use of pure autologous concentrations of platelets, PRF, as a graft material has shown promising effects. However, the durability of PRF is limited, as it usually resorbs within 10-14 days. Thus, Mourão et al. introduced a new technique for PRF preparation, in which the resulting newly formed protein remains stable for a long time, up to 4 to 6 months. The buffy coat layer of the PRF was then mixed with the denatured albumin gel and cooled to room temperature to form a new autologous albumin gel-platelet-rich fibrin mixture (Alb-PRF) which has the ability to heal, represented by the delayed and gradual release of growth factors present in the buffy coat layer of PRF throughout the prolonged dissolution of the albumin gel.
This research aimed to evaluate the effect of an autologous Alb-PRF on bone regeneration after lateral sinus lifting via 3D volumetric analysis. The null hypothesis of this research was that there would be no significant difference between the group that would be treated by lateral sinus lift and Alb-PRF application and that would be treated by lateral sinus lift with bone graft for bone regeneration.
- Conditions
- Sinus Perforation, Dental Implant Failure Nos
- Being tested
- Guided Lateral Sinus Lifting with bone graft, Guided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich Fibrin, Guided Lateral Sinus Lifting with sticky bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Lateral Sinus Lifting with bone graftProcedure or surgery
Lateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then bone graft only will be used.
Guided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich FibrinProcedure or surgery
Lateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then an autologous Alb-PRF only will be used
Guided Lateral Sinus Lifting with sticky boneProcedure or surgery
Lateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then sticky bone [bone graft with Alb-PRF] only will be used
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Lateral window was done using surgical guide for placement of implants in posterior edentulous maxillary regions. Then bone graft only will be used. Receives: Procedure: Guided Lateral Sinus Lifting with bone graft |
| Group II | Experimental | Lateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then an autologous Alb-PRF only will be used Receives: Procedure: Guided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich Fibrin |
| Group III | Experimental | Lateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then sticky bone [bone graft with Alb-PRF] only will be used Receives: Procedure: Guided Lateral Sinus Lifting with sticky bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
using implant stability quotient device
Measured: 12-months
Secondary outcomes (1)
Vertical bone height gain
assessed by CBCT.by measuring the distance from alveolar crest to sinus floor
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start26 Jan 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus PerforationStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Model description
- guided Lateral sinus lift with bone graft only
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Elamrousy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348094
- Sponsor's protocol ID
- KFSIRB200-907
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2026
- Last updated
- 18 Feb 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Guided Lateral Sinus Floor Elevation Using Autologous Serum Albumin/Platelet Rich Fibrin Combined With Serum Albumin Membrane: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07348094
- Acronym / sponsor ID
- KFSIRB200-907
- Conditions
- Sinus Perforation, Dental Implant Failure Nos
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 16 Jan 2026 (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 research aimed to evaluate the effect of an autologous Alb-PRF on bone regeneration after lateral sinus lifting via 3D volumetric analysis. The null hypothesis of this research was that there would be no significant difference between the group that would be treated by lateral sinus lift and Alb-PRF application and that would be treated by lateral sinus lift with bone graft for bone regeneration.
Detailed description
Sinus floor augmentation became a widely accepted surgical procedure to improve the amount of bone volume before implant placement. According to the guided bone regeneration principles, in the sinus lift procedure, bone graft was demonstrated to act as space holder under the elevated sinus membrane. The osteogenic source for the bone healing derives from two different anatomic sites: the basal bone of the sinus cavity and the periosteum represented as basal cell layer of the Schneiderian membrane.
Proper and accurate design and location of the lateral side window is necessary to facilitate the sinus lifting process and help the surgeon to successfully lift the sinus membrane. In addition, direct visualization helps in better packing of the entire graft space, which is essential to provide primary stability for the simultaneous insertion of the implants with the sinus elevation procedure.
The application of digital technology has proven to be a valuable tool for diagnosis and treatment planning. Data obtained from CBCT scans, digital oral scans, and facial scans can be integrated and manipulated using special computer software, providing surgeons with an interactive interface to perform virtual surgery planning before the actual surgery.
The precision of stereolithographic guides may mitigate risks associated with anatomical variations in atrophic maxillae, potentially reducing membrane perforation and optimizing lateral window osteotomy and implant placement accuracy which are key factors this study evaluates.
Recently, the use of pure autologous concentrations of platelets, PRF, as a graft material has shown promising effects. However, the durability of PRF is limited, as it usually resorbs within 10-14 days. Thus, Mourão et al. introduced a new technique for PRF preparation, in which the resulting newly formed protein remains stable for a long time, up to 4 to 6 months. The buffy coat layer of the PRF was then mixed with the denatured albumin gel and cooled to room temperature to form a new autologous albumin gel-platelet-rich fibrin mixture (Alb-PRF) which has the ability to heal, represented by the delayed and gradual release of growth factors present in the buffy coat layer of PRF throughout the prolonged dissolution of the albumin gel.
This research aimed to evaluate the effect of an autologous Alb-PRF on bone regeneration after lateral sinus lifting via 3D volumetric analysis. The null hypothesis of this research was that there would be no significant difference between the group that would be treated by lateral sinus lift and Alb-PRF application and that would be treated by lateral sinus lift with bone graft for bone regeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- guided Lateral sinus lift with bone graft only
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: Guided Lateral Sinus Lifting with bone graftLateral window was done using surgical guide for placement of implants in posterior edentulous maxillary regions. Then bone graft only will be used. |
| Group II | Experimental | Procedure: Guided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich FibrinLateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then an autologous Alb-PRF only will be used |
| Group III | Experimental | Procedure: Guided Lateral Sinus Lifting with sticky boneLateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then sticky bone [bone graft with Alb-PRF] only will be used |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males and females ≥18 years of age.
Key exclusion criteria (3 listed)
- - Patients with uncontrolled systemic diseases.
- History of chronic maxillary sinus pathology.
- Heavy smokers or patients with poor oral hygiene.
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 |
|---|---|---|
| Guided Lateral Sinus Lifting with bone graftLateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then bone graft only will be used. | Procedure or surgery | Group I |
| Guided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich FibrinLateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then an autologous Alb-PRF only will be used | Procedure or surgery | Group II |
| Guided Lateral Sinus Lifting with sticky boneLateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then sticky bone [bone graft with Alb-PRF] only will be used | Procedure or surgery | Group III |
Primary outcome
Implant stability
Time frame: 12-months
using implant stability quotient device
1 secondary outcome
Vertical bone height gain
Time frame: 12 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 18 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Lateral Sinus Lifting with bone graft, Guided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich Fibrin and Guided Lateral Sinus Lifting with sticky bone in people with Sinus Perforation and Dental Implant Failure Nos, run by Kafrelsheikh University 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 8 inclusion and 3 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 18 Feb 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 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?
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 walid elamrousy (01229460097, waled_hammed@den.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability (time frame: 12-months). 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 18 Feb 2026.