Comparative Evaluation of Xenograft Alone and Sticky Bone in Sinus Lift With Concurrent Implant Placement: A Randomized Controlled Trial
| Registry | NCT07444970 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 18 (Estimated) |
| Sponsor | Fayoum University (Other) |
| Conditions | Sinus Lifting, Dental Implant, Sticky Bone |
| Interventions | Sticky bone, traditional xenograft (Procedure) |
| Dates | start 2026-06-01 (estimated), primary completion 2027-03-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-03-03, last updated 2026-05-26 |
Related Papers Related Patents Related Grants Related Experts
All trials for Sinus Lifting All trials for Dental Implant All trials of Sticky bone All trials of traditional xenograft
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sticky Bone Group | Experimental | Procedure: Sticky bone | In this group sticky bone is used as a bone graft material in sinus lift procedures with implant placement |
| Xenograft Group | Active comparator | Procedure: traditional xenograft | In this group traditional xenografts in sinus lift procedures with implant placement |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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. Exclusion Criteria: * 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.