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?
University of Queensland
50 participants
Mar 13, 2023
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
Inclusion Criteria6
- Individuals are at least 18 years of age, medically healthy or with mild controlled systemic disease, able to undergo oral surgical procedures under local or general anaesthesia (ASA I and II; American Society of Anesthesiologists, Schaumburg, Illinois, USA).
- Adequate plaque control (FM plaque and BOP scores equal to or greater than 25%) at study baseline
- Residual alveolar bone height of the edentulous maxilla below the floor of the maxillary sinus less than or equal to 4.9 mm and equal to or greater than 3.0 mm (measured at the mid-point of the edentulous space where both the coronal and sagittal planes intersect) and residual alveolar bone width of greater than or equal to 6mm.
- If bilateral sinus augmentation was required, only one sinus was randomly selected and used for the purposes of this study.
- Teeth at the surgical site which require removal are extracted a minimum of 12 weeks prior to sinus floor elevation
- Treated and stable periodontal disease as assessed by specialist Periodontists (JA & SI) with stability defined as having a full mouth bleeding score great than 20% and no sites of residual periodontal probing depth greater than 5mm (Lang & Tonetti 2003).
Exclusion Criteria9
- Pregnancy at the time of recruitment
- Alcoholism or chronic drug abuse
- Patients who smoke more than 10 cigarettes per day
- Medications which interferes with bone formation
- History of local radiation therapy
- Severe parafunction
- Signs and symptoms consistent with acute maxillary sinusitis
- Significant soft tissue thickening (=2mm thickening) or sinus opacification in the sinus of interest.
- Previous maxillary sinus augmentation.
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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 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)
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ACTRN12622000054718