Sinus LiftingNCT07444970
Comparative Evaluation of Xenograft Alone and Sticky Bone in Sinus Lift With Concurrent Implant Placement
A study testing Sticky bone and traditional xenograft in people with Sinus Lifting and Dental Implant, run by Fayoum University.
Trial summary
Introduction \& Background: Modern dental implantology offers solutions for patients with edentulism in the maxillary arch, where sinus pneumatization and alveolar ridge atrophy are common conditions. This often requires sinus floor elevation and bone grafting prior to implant placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Lifting, Dental Implant, Sticky Bone
- What is being tested?
- Sticky bone and traditional xenograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older.
- Patients presenting with residual bone height of less than 5 millimeters in the posterior maxilla requiring sinus floor elevation for dental implant placement.
- Good oral hygiene status with absence of active periodontal disease.
- Medically fit patients with no systemic conditions contraindicating oral surgical procedures.
- Non-smokers.
- Absence of acute or chronic maxillary sinusitis.
Who cannot join
- Presence of uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus or severe cardiovascular diseases).
- Immunocompromised patients.
- History of radiation therapy to the head and neck region.
- History of sinus surgery or sinus pathology that may interfere with sinus floor elevation procedures.
- Presence of active infection or inflammation at the intended surgical site.
- Use of medications known to affect bone metabolism or healing, such as bisphosphonates or long-term corticosteroid therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Evaluation of Xenograft Alone and Sticky Bone in Sinus Lift With Concurrent Implant Placement: A Randomized Controlled Trial
Introduction \& Background:
Modern dental implantology offers solutions for patients with edentulism in the maxillary arch, where sinus pneumatization and alveolar ridge atrophy are common conditions. This often requires sinus floor elevation and bone grafting prior to implant placement. Techniques such as the lateral window approach and osteotome-mediated sinus floor elevation aim to achieve sufficient vertical bone height for successful implant placement.
Read more
Autogenous bone grafts have long been considered the gold standard; however, their use is associated with limitations including donor site morbidity and graft volume loss, which has encouraged the exploration of alternative grafting materials. Sticky bone is a term used in oral surgery and implantology to describe a cohesive, moldable, and adhesive bone graft material prepared by combining particulate bone graft material (xenograft) with biological additives such as Platelet-Rich Plasma (PRP) or Platelet-Rich Fibrin (PRF).
Platelet-Rich Fibrin (PRF), which is used in the present study, is an autologous leukocyte and platelet-rich fibrin matrix containing cytokines, platelets, and stem cells. PRF acts as a biodegradable scaffold that promotes microvascularization and guides epithelial cell migration. In addition, PRF may serve as a carrier for regenerative cells and allows sustained release of growth factors over a period ranging from one to four weeks, thereby enhancing the wound healing environment.
Objectives:
The study aims to assess the clinical efficacy of sticky bone as a bone graft material in sinus lift procedures compared with conventional xenograft materials.
Methods:
A randomized clinical trial will be conducted comparing two groups: one receiving sticky bone with simultaneous implant placement and another receiving xenograft with implant placement. Preoperative assessment will include Cone Beam Computed Tomography (CBCT) imaging, followed by postoperative monitoring to evaluate bone height and implant stability.
Study Design:
Patients fulfilling the inclusion and exclusion criteria will be recruited from the dental clinic. Written informed consent will be obtained from all participants after explanation of study procedures, potential risks, and expected benefits. Eligible patients will be randomly allocated into two equal groups using a computer-generated randomization program: Group 1 (Sticky Bone group) and Group 2 (Xenograft group).
Statistical Analysis:
Sample size calculation was performed using G*Power software version 3.1.9.7. The statistical test family selected was the t-test. Based on data from a previous study, a total of 16 participants were required to achieve a study power of 80% with a significance level (alpha) of 0.05. To compensate for potential dropouts, the total sample size was increased to 18 participants (9 patients per group).
- Conditions
- Sinus Lifting, Dental Implant, Sticky Bone
- Being tested
- Sticky bone, traditional xenograft
- Keywords
- Dental implants, sticky bone, bone graft, sinus lift, PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sticky boneProcedure or surgery
Sticky bone graft prepared using Platelet-Rich Fibrin (PRF) combined with xenograft material during sinus floor elevation.
traditional xenograftProcedure or surgery
Traditional xenografts as a bone graft material will be used during sinus floor elevation.
| Study group | Role | What they receive |
|---|---|---|
| Sticky Bone Group | Experimental | In this group sticky bone is used as a bone graft material in sinus lift procedures with implant placement Receives: Procedure: Sticky bone |
| Xenograft Group | Active comparator | In this group traditional xenografts in sinus lift procedures with implant placement Receives: Procedure: traditional xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical Bone Height Gain
The primary outcome measure will be the mean increase in vertical bone height (in millimeters) following sinus floor elevation procedures. Bone height will be assessed immediately postoperatively and at 6 months postoperatively using Cone Beam Computed Tomography (CBCT) imaging.
Measured: Immediately postoperatively and 6 months after sinus floor elevation
Secondary outcomes (1)
Implant Insertion Torque
Implant insertion torque will be measured at the time of implant placement using a calibrated surgical torque device and recorded in Newton centimeters (N·cm) to evaluate primary implant stability.
Measured: At the time of implant placement (during surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sinus LiftingStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohga Ahmed Abd El Aziz, Fayoum University
- Investigators
- Mohamed Bahaa Khedr, Professor, Principal investigator, Oral and Maxillofacial Surgery Department Faculty of Dentistry, Fayoum UniversityShaimaa Mghawry Ibrahim, Lecturer, Principal investigator, Oral and Maxillofacial Surgery Department Faculty of Dentistry, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444970
- Sponsor's protocol ID
- Sticky bone with Implants
- Status last verified
- May 2026
- First submitted
- 25 Feb 2026
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lee EA. Subperiosteal Minimally Invasive Aesthetic Ridge Augmentation Technique (SMART): A New Standard for Bone Reconstruction of the Jaws. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):165-173. doi: 10.11607/prd.3171.
PubMed 28196155Abushama AA, Alim N, AlTuraiki AM, AlQahtani TT, Alotaibi NT, AlQahtani MM, AlQahtani NM. Comparison of xenograft and allograft bone graft for oral and maxillofacial surgical preparation prior to dental implantation: A systematic review. F1000Res. 2025 Jul 22;14:718. doi: 10.12688/f1000research.163924.1. eCollection 2025.
PubMed 40951319Khachatryan L, Khachatryan G, Hakobyan G, Khachatryan A. Simultaneous endoscopic endonasal sinus surgery and sinus augmentation with immediate implant placement: A retrospective clinical study of 23 patients. J Craniomaxillofac Surg. 2019 Aug;47(8):1233-1241. doi: 10.1016/j.jcms.2019.04.004. Epub 2019 Apr 19.
PubMed 31080051Stern A, Green J. Sinus lift procedures: an overview of current techniques. Dent Clin North Am. 2012 Jan;56(1):219-33, x. doi: 10.1016/j.cden.2011.09.003.
PubMed 22117952Sogo M, Ikebe K, Yang TC, Wada M, Maeda Y. Assessment of bone density in the posterior maxilla based on Hounsfield units to enhance the initial stability of implants. Clin Implant Dent Relat Res. 2012 May;14 Suppl 1:e183-7. doi: 10.1111/j.1708-8208.2011.00423.x. Epub 2011 Dec 16.
PubMed 22176704Silva LD, de Lima VN, Faverani LP, de Mendonca MR, Okamoto R, Pellizzer EP. Maxillary sinus lift surgery-with or without graft material? A systematic review. Int J Oral Maxillofac Surg. 2016 Dec;45(12):1570-1576. doi: 10.1016/j.ijom.2016.09.023. Epub 2016 Oct 17.
PubMed 27765427Starch-Jensen T, Aludden H, Hallman M, Dahlin C, Christensen AE, Mordenfeld A. A systematic review and meta-analysis of long-term studies (five or more years) assessing maxillary sinus floor augmentation. Int J Oral Maxillofac Surg. 2018 Jan;47(1):103-116. doi: 10.1016/j.ijom.2017.05.001. Epub 2017 May 22.
PubMed 28545806
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Xenograft Alone and Sticky Bone in Sinus Lift With Concurrent Implant Placement: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07444970
- Acronym / sponsor ID
- Sticky bone with Implants
- Conditions
- Sinus Lifting, Dental Implant, Sticky Bone
- Keywords
- Dental implants, sticky bone, bone graft, sinus lift, PRF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 3 Mar 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.
Introduction \& Background:
Modern dental implantology offers solutions for patients with edentulism in the maxillary arch, where sinus pneumatization and alveolar ridge atrophy are common conditions. This often requires sinus floor elevation and bone grafting prior to implant placement. Techniques such as the lateral window approach and osteotome-mediated sinus floor elevation aim to achieve sufficient vertical bone height for successful implant placement.
Autogenous bone grafts have long been considered the gold standard; however, their use is associated with limitations including donor site morbidity and graft volume loss, which has encouraged the exploration of alternative grafting materials. Sticky bone is a term used in oral surgery and implantology to describe a cohesive, moldable, and adhesive bone graft material prepared by combining particulate bone graft material (xenograft) with biological additives such as Platelet-Rich Plasma (PRP) or Platelet-Rich Fibrin (PRF).
Platelet-Rich Fibrin (PRF), which is used in the present study, is an autologous leukocyte and platelet-rich fibrin matrix containing cytokines, platelets, and stem cells. PRF acts as a biodegradable scaffold that promotes microvascularization and guides epithelial cell migration. In addition, PRF may serve as a carrier for regenerative cells and allows sustained release of growth factors over a period ranging from one to four weeks, thereby enhancing the wound healing environment.
Objectives:
The study aims to assess the clinical efficacy of sticky bone as a bone graft material in sinus lift procedures compared with conventional xenograft materials.
Methods:
A randomized clinical trial will be conducted comparing two groups: one receiving sticky bone with simultaneous implant placement and another receiving xenograft with implant placement. Preoperative assessment will include Cone Beam Computed Tomography (CBCT) imaging, followed by postoperative monitoring to evaluate bone height and implant stability.
Study Design:
Patients fulfilling the inclusion and exclusion criteria will be recruited from the dental clinic. Written informed consent will be obtained from all participants after explanation of study procedures, potential risks, and expected benefits. Eligible patients will be randomly allocated into two equal groups using a computer-generated randomization program: Group 1 (Sticky Bone group) and Group 2 (Xenograft group).
Statistical Analysis:
Sample size calculation was performed using G*Power software version 3.1.9.7. The statistical test family selected was the t-test. Based on data from a previous study, a total of 16 participants were required to achieve a study power of 80% with a significance level (alpha) of 0.05. To compensate for potential dropouts, the total sample size was increased to 18 participants (9 patients per group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sticky Bone Group | Experimental | Procedure: Sticky boneIn this group sticky bone is used as a bone graft material in sinus lift procedures with implant placement |
| Xenograft Group | Active comparator | Procedure: traditional xenograftIn this group traditional xenografts in sinus lift procedures with implant placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years and older.
- Patients presenting with residual bone height of less than 5 millimeters in the posterior maxilla requiring sinus floor elevation for dental implant placement.
- Good oral hygiene status with absence of active periodontal disease.
- Medically fit patients with no systemic conditions contraindicating oral surgical procedures.
- Non-smokers.
Key exclusion criteria (6 listed)
- Presence of uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus or severe cardiovascular diseases).
- Immunocompromised patients.
- History of radiation therapy to the head and neck region.
- History of sinus surgery or sinus pathology that may interfere with sinus floor elevation procedures.
- Presence of active infection or inflammation at the intended surgical site.
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 |
|---|---|---|
| Sticky boneSticky bone graft prepared using Platelet-Rich Fibrin (PRF) combined with xenograft material during sinus floor elevation. | Procedure or surgery | Sticky Bone Group |
| traditional xenograftTraditional xenografts as a bone graft material will be used during sinus floor elevation. | Procedure or surgery | Xenograft Group |
Primary outcome
Vertical Bone Height Gain
Time frame: Immediately postoperatively and 6 months after sinus floor elevation
The primary outcome measure will be the mean increase in vertical bone height (in millimeters) following sinus floor elevation procedures. Bone height will be assessed immediately postoperatively and at 6 months postoperatively using Cone Beam Computed Tomography (CBCT) imaging.
1 secondary outcome
Implant Insertion Torque
Time frame: At the time of implant placement (during surgery)
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 26 May 2026.
- Background: PubMed 28196155Lee EA. Subperiosteal Minimally Invasive Aesthetic Ridge Augmentation Technique (SMART): A New Standard for Bone Reconstruction of the Jaws. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):165-173. doi: 10.11607/prd.3171.
- Background: PubMed 40951319Abushama AA, Alim N, AlTuraiki AM, AlQahtani TT, Alotaibi NT, AlQahtani MM, AlQahtani NM. Comparison of xenograft and allograft bone graft for oral and maxillofacial surgical preparation prior to dental implantation: A systematic review. F1000Res. 2025 Jul 22;14:718. doi: 10.12688/f1000research.163924.1. eCollection 2025.
- Background: PubMed 31080051Khachatryan L, Khachatryan G, Hakobyan G, Khachatryan A. Simultaneous endoscopic endonasal sinus surgery and sinus augmentation with immediate implant placement: A retrospective clinical study of 23 patients. J Craniomaxillofac Surg. 2019 Aug;47(8):1233-1241. doi: 10.1016/j.jcms.2019.04.004. Epub 2019 Apr 19.
- Background: PubMed 22117952Stern A, Green J. Sinus lift procedures: an overview of current techniques. Dent Clin North Am. 2012 Jan;56(1):219-33, x. doi: 10.1016/j.cden.2011.09.003.
- Background: PubMed 22176704Sogo M, Ikebe K, Yang TC, Wada M, Maeda Y. Assessment of bone density in the posterior maxilla based on Hounsfield units to enhance the initial stability of implants. Clin Implant Dent Relat Res. 2012 May;14 Suppl 1:e183-7. doi: 10.1111/j.1708-8208.2011.00423.x. Epub 2011 Dec 16.
- Background: PubMed 27765427Silva LD, de Lima VN, Faverani LP, de Mendonca MR, Okamoto R, Pellizzer EP. Maxillary sinus lift surgery-with or without graft material? A systematic review. Int J Oral Maxillofac Surg. 2016 Dec;45(12):1570-1576. doi: 10.1016/j.ijom.2016.09.023. Epub 2016 Oct 17.
- Results publication: PubMed 28545806Starch-Jensen T, Aludden H, Hallman M, Dahlin C, Christensen AE, Mordenfeld A. A systematic review and meta-analysis of long-term studies (five or more years) assessing maxillary sinus floor augmentation. Int J Oral Maxillofac Surg. 2018 Jan;47(1):103-116. doi: 10.1016/j.ijom.2017.05.001. Epub 2017 May 22.
- Individual participant dataSharing planned: Yes
Related trials for Sinus Lifting
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Endoscopic-Assisted Versus Conventional Crestal Sinus Lift
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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.
Mohamed Bahaa Khedr, Professor principal investigator
Oral and Maxillofacial Surgery Department Faculty of Dentistry, Fayoum University
Shaimaa Mghawry Ibrahim, Lecturer principal investigator
Oral and Maxillofacial Surgery Department Faculty of Dentistry, Fayoum University
Questions about this trial
What is this clinical trial studying?
A study testing Sticky bone and traditional xenograft in people with Sinus Lifting and Dental Implant, run by Fayoum University.
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 6 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: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mohga Ahmed Abd El Aziz (+201206874469, Mohga.ahmed@dent.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical Bone Height Gain (time frame: Immediately postoperatively and 6 months after sinus floor 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 NCT07444970, which also lists 7 linked publications.
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 26 May 2026.