Comparative Evaluation of Xenograft Alone and Sticky Bone in Sinus Lift With Concurrent Implant Placement

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFayoum University

About this 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.

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sticky bone

    Procedure/Surgery

    Sticky bone graft prepared using Platelet-Rich Fibrin (PRF) combined with xenograft material during sinus floor elevation.

  • traditional xenograft

    Procedure/Surgery

    Traditional xenografts as a bone graft material will be used during sinus floor elevation.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Sticky Bone GroupExperimental treatment 1 intervention
Group B: Xenograft GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
At the time of implant placement (during surgery)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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