A prospective controlled trial comparing xenograft/autogenous bone and collagen-stabilized xenograft for maxillary sinus augmentation-Complications, patient-reported outcomes and volumetric analysis

Abstract

Objective: Compare maxillary sinus augmentation (MSA) using two different materials-anorganic bovine bone mineral (ABBM) + autogenous bone (AB) (control group) vs. collagen-stabilized ABBM (test group) in terms of complications, patient-reported outcome measures (PROMs) and volumetric analysis.

Materials and methods: Sixty patients underwent sinus augmentation (30 control + 30 test group). Intra- and postoperative complications were recorded. PROMs measured the impact of grafting on daily activities, pain and morbidity. CT scans were used to measure graft volume, ridge height, material selection and degree of contact of graft-to-surrounding sinus walls. Dental implant placement parameters were also recorded.

Results: All complications were minor and did not prevent completion of the augmentation or subsequent implant placement. Schneiderian membrane perforation was the most frequently encountered complication. Both treatment groups reported moderate limitation in the 1st 48 hr post-surgery but little or none by day 3 or 4. Jaw opening, chewing and bruising were significantly higher in the control group. The impact on work and social life was moderate initially but reduced to little or none by the 2nd day. Mild to moderate pain and interference to daily activities were reported for the first 3 days requiring the use of NSAIDs only. A mean graft volume of 1.46 cm³ (±0.77) was calculated in the control group and 1.27 cm³ (±0.65) in the test group. Extent of contact between graft and surrounding sinus walls had a significant impact on bone volume. Shorter (8 mm) implants were utilized more frequently in the test group, which was also more likely to require additional vertical augmentation, but this was not statistically significant.

Conclusion: MSA using a lateral wall approach is safe and associated with mild to moderate pain and restrictions to daily activities for 48-72 hr. Patients' reports of morbidity were greater with autogenous bone harvesting. Collagen-stabilized ABBM provides comparable bone volume to AB + ABBM that is sufficient for placement of implants of adequate size with no need for further vertical augmentation. Engaging the surrounding sinus walls had a significant positive impact on graft volume.

Keywords: Bio-Oss; Bio-Oss Collagen; Sinus floor elevation; anorganic bovine bone; bone substitute; clinical trial; guided bone regeneration; patient-centred outcomes; volumetric outcomes.