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

May 21, 2026 updated by: Mohga Ahmed Abd El Aziz, Fayoum University

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sticky Bone Group
In this group sticky bone is used as a bone graft material in sinus lift procedures with implant placement
Procedure: Sticky bone
Sticky bone graft prepared using Platelet-Rich Fibrin (PRF) combined with xenograft material during sinus floor elevation.
Active Comparator: Xenograft Group
In this group traditional xenografts in sinus lift procedures with implant placement
Procedure: traditional xenograft
Traditional xenografts as a bone graft material will be used during sinus floor elevation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately postoperatively and 6 months after sinus floor elevation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Insertion Torque
Time Frame: At the time of implant placement (during surgery)
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.
At the time of implant placement (during surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Investigators

  • Principal Investigator: Mohamed Bahaa Khedr, Professor, Oral and Maxillofacial Surgery Department Faculty of Dentistry, Fayoum University
  • Principal Investigator: Shaimaa Mghawry Ibrahim, Lecturer, Oral and Maxillofacial Surgery Department Faculty of Dentistry, Fayoum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sticky bone with Implants

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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