RecruitingACTRN12622000054718

Assessing the impact of the size of a maxillary sinus graft and its contact with surrounding sinus walls on bone regeneration

Graft contact area to volume ratio – a critical factor in new bone formation after maxillary sinus augmentation in adults?


Sponsor

University of Queensland

Enrollment

50 participants

Start Date

Mar 13, 2023

Study Type

Observational

Conditions

Summary

Based on the graft healing after maxillary sinus augmentation, the fraction of new bone formation is hypothesized to be positively correlated to the area of resident bone walls in contact with the bone graft and negatively correlated to the volume of the graft. The inter-relation of these parameters on new bone formation has never been investigated. As such, the ratio of surface area in contact with the graft and the graft volume will be explored in this study.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When a patient needs dental implants in the upper jaw but lacks enough bone height beneath the sinus cavity, a procedure called sinus augmentation is performed — essentially adding bone graft material to the floor of the sinus to create enough depth for implant placement. How much new bone grows into this graft depends on several factors, but researchers have not yet explored whether the shape and size of the graft area itself — specifically the ratio of the bony wall contact surface to the graft volume — affects how well bone regenerates. This study is collecting detailed pre- and post-surgical data on patients undergoing sinus augmentation at the University of Queensland. Using CT scans and clinical measurements, researchers will map the geometry of the graft and analyse how it correlates with the amount of new bone formed at follow-up biopsy. You may be eligible if you are 18 or older, are in good general health, have an edentulous (toothless) upper jaw with insufficient bone height for implants, and have adequate plaque control and stable periodontal (gum) health. Heavy smokers, pregnant individuals, and people on medications that interfere with bone formation are not eligible. This study could refine how surgeons plan sinus grafting procedures, potentially leading to better implant outcomes.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

70 patients included in this trial will be undergoing maxillary sinus augmentation for the purposes of dental implant rehabilitation. This procedure allows new bone formation thereby facilitating dent

70 patients included in this trial will be undergoing maxillary sinus augmentation for the purposes of dental implant rehabilitation. This procedure allows new bone formation thereby facilitating dental implant placement. The extent of new bone formation will be measured histologically and correlated to sinus graft volume and degree of contact this graft has with surrounding bone walls. The surgical procedures will be carried out by specialist clinicians (periodontists) with at more than 15 years experience in a specialist private practice. A bone sample will be collected at the time of dental implant placement (6 months after grafting surgery). Histological preparation and measurements will be performed at a university laboratory using well established protocols and an experienced scientific team. This procedure is routinely performed in patients requiring dental implant rehabilitation in the posterior maxilla in situations of insufficient bone due to maxillary sinus pneumatization. The same procedure will still be carried out when clinically indicated in patients who elect to not participate in this trial or withdraw at any time.


Locations(1)

QLD, Australia

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ACTRN12622000054718