Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation Procedure

NCT07512011 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY20251371
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sinus Lifting; Bone Grafting

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Interventions

Bone grafting on both sides DEVICE

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 \[0.3-0.6 mm\]).

Bone graft patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Dentistry

Columbus, Ohio, 43210, United States

Location

Central Study Contacts

Binnaz Leblebicioglu, DDS, MS, PhD

CONTACT

614-292-0371; leblebicioglu.1@osu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 6, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)