Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation Procedure

Official title

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

Overview

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.

Interventions

• 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 receiv

Primary outcome measures

• Change in ridge dimensions [Time frame: Prior to procedure; 10 days post-procedure; 1 month post-procedure; 6 months post-procedure]
• Change in Bone Density [Time frame: Prior to the procedure; 4 months post-procedure]
• Bone quality at 6 months [Time frame: About 6 months post-grafting procedure]
• Patient-Centered Outcomes [Time frame: Days 1-10 post-procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• The Ohio State University College of Dentistry — Columbus

Identifiers

NCT: NCT07512011 · STUDY20251371

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗