Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation Procedure

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07512011
Status
Not Yet Recruiting

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Conditions

  • Bone Grafting
  • Sinus Lifting

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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 \[0.3-0.6 mm\]).

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Change in ridge dimensions [ Time Frame: Prior to procedure; 10 days post-procedure; 1 month post-procedure; 6 months post-procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University College of DentistryColumbusOhio43210
Binnaz Leblebicioglu, DDS, MS, PhD
614-292-0371

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