Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation Procedure (MSA-BGC)

Maxillary Sinus Augmentation Through Lateral Window Technique: Outcomes of Different Bone Graft Combinations (MSA-BGC STUDY)

This study investigates the outcomes of a surgical procedure that is performed to increase bone support at a future implant site on the upper back jaw area. This procedure requires placing bone graft material and/or substitutes into the maxillary sinus. The average healing time for the graft is about 6 months. Then, the site will be ready for dental implant. The study will compare healing outcomes of two types of bone graft mixtures used on the same patient (right and left upper jaw regions). The outcomes will be evaluated through clinical examination but also by studying the quality of the tissue through tissue biopsies obtained from grafted sites.

Study Overview

• Status: Not yet recruiting
• Conditions: Sinus Lifting; Bone Grafting
• Intervention / Treatment: Device: Bone grafting on both sides

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Binnaz Leblebicioglu, DDS, MS, PhD; Phone Number: 614-292-0371; Email: leblebicioglu.1@osu.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Dentistry
      • Contact: Binnaz Leblebicioglu, DDS, MS, PhD; Phone Number: 614-292-0371; Email: leblebicioglu.1@osu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients of the Graduate Periodontics Clinic at The Ohio State University College of Dentistry who missing their upper back teeth (both sides) and interested in having implant supported dental restorations

Description

Inclusion Criteria:

• Indication of bilateral sinus augmentation through lateral window technique to prepare maxillary right and left posterior edentulous sites for a single or multiple unit implant supported restorations.
• Systemically healthy with controlled conditions
• Periodontally healthy/controlled dentition
• No known chronic and/or seasonal sinusitis
• No previous ear, nose, throat, and sinus surgeries
• Non-smokers
• Willing to be treated with allograft, xenograft and/or synthetic bone graft materials

Exclusion Criteria:

• 1. Indication of sinus augmentation through indirect techniques (≥5 mm initial alveolar ridge height from crest to maxillary sinus floor)
• Implant placement surgery planned somewhere else
• Implant placement planned at the time of sinus augmentation
• Cases requiring major alveolar ridge augmentation concurrent with sinus augmentation
• Cases requiring the use of a partial denture with buccal flange extension during the post-operative period
• History of previously failed implant and/sinus augmentation procedures
• History of tumors and/or radiation and/or chemotherapy
• Uncontrolled systemic health problems and ENT/sinus concerns
• Uncontrolled periodontal/dental problems
• Intake of medications affecting wound or bone healing (e.g., corticosteroids, immunosuppressants, etc.)
• Alcohol or drug abuse
• Active smokers (patient should be a non-smoker for at least 1 year prior to sinus augmentation procedure)
• Unable/unwilling to follow post-operative instructions, rejecting to be treated with allograft, xenograft and/or synthetic bone graft materials
• Unable/unwilling to attend scheduled study visits
• Participation in another clinical trial within 3 months prior to planned study entry

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Bone graft patients; Patients who are missing their upper back teeth and interested in having implant supported dental restorations, and who require direct sinus augmentation procedure on both right and left maxillary sinus prior to implant placement.

Device: Bone grafting on both sides; The surgical protocol is part of standard of care and will not be changed due to the study except the choice of the bone graft. Routinely (as the standard protocol), allograft (Straumann Allograft mineralized cortical granules [0.25-1mm]) is mixed with xenograft (bovine bone; Bio-Oss® small particles [0.25-1mm]) bone graft and placed into sinus. In this study, one randomly chosen sinus will receive this mixture (50:50 by volume) as the control. The other sinus on the same patient will receive a 50:50 (by volume) mixture of the same allograft with synthetic carbonate apatite (Cytrans® granules S size [0.3-0.6 mm]).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ridge dimensions	Dimensions of the alveolar ridge, determined by measurements using an intraoral scanner	Prior to procedure; 10 days post-procedure; 1 month post-procedure; 6 months post-procedure
Change in Bone Density	Bone density around the dental implant, measured via CBCT	Prior to the procedure; 4 months post-procedure
Bone quality at 6 months	At implant surgery, 6 months post-grafting, a bone core sample will be taken. This tissue is normally removed during the implant procedure but it typically discarded. Histological analysis will be done on the sample	About 6 months post-grafting procedure
Patient-Centered Outcomes	Participants will be asked to keep a diary to record pain level and pain medications taken.	Days 1-10 post-procedure

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY20251371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No