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

Not Applicable

Recruiting

• Conditions: alveolar bone regeneration; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622000054718
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-18
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•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 Criteria

•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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area fraction of new bone formation - assessed histologically [ 6 months after maxillary sinus augmentation ]

Secondary Outcome Measures

Name	Time	Method
Percentage bone graft osseointegrated - assessed histologically [ 6 months after maxillary sinus augmentation];area fraction of residual graft - assessed histologically [ 6 months after maxillary sinus augmentation];area fraction of non-mineralized tissue - assessed histologically [ 6 months after maxillary sinus augmentation];area fraction of lamellar bone - assessed histologically [ 6 months after maxillary sinus augmentation];area fraction of woven bone - assessed histologically [ 6 months after maxillary sinus augmentation]