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NCT Number: NCT07512011

Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation Procedure

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University College of Dentistry

Columbus, Ohio, 43210, United States

Location contact

Binnaz Leblebicioglu, DDS, MS, PhD

CONTACT

[email protected]

614-292-0371

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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]).

Primary outcomes

  1. Change in ridge dimensions

    Time frame: Prior to procedure; 10 days post-procedure; 1 month post-procedure; 6 months post-procedure

    Dimensions of the alveolar ridge, determined by measurements using an intraoral scanner

  2. Change in Bone Density

    Time frame: Prior to the procedure; 4 months post-procedure

    Bone density around the dental implant, measured via CBCT

  3. Bone quality at 6 months

    Time frame: About 6 months post-grafting procedure

    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

  4. Patient-Centered Outcomes

    Time frame: Days 1-10 post-procedure

    Participants will be asked to keep a diary to record pain level and pain medications taken.

Study contacts

Contact information is provided by the study sponsor or research team.

Binnaz Leblebicioglu, DDS, MS, PhD

CONTACT

[email protected]

614-292-0371

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Acronym: MSA-BGC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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