Bone Quality and Quantity in the Maxillary Sinus Grafted With Xenograft or Synthetic Bone Substitute: A Radiographic and Histomorphometric Randomized Controlled Clinical Study
Phase: PHASE2
Conditions: Alveolar Bone Resorption, Sequela, Tooth Extrusion
Sponsor: Mohanad Al-Sabbagh

Document Coversheet
Study Title: Bone Quality and Quantity in the Maxillary Sinus Grafted With Xenograft or 
Synthetic Bone Substitute: A Radiographic and Histomorphometric Randomized Controlled 
Clinical Study
Institution/Site: 
University of Kentucky 
Document (Approval/Update) Date:
9/7/2023 
NCT Number:
NCT04433117
IRB Number
58349
Coversheet created:
2/7/2024

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Statistical Analysis 
For bone radiographic bone height analysis, ten subjects per group will provide 80% power to detect an effect size of 
1.4 on newly formed bone using an independent two group t-test with a 5% two-sided significance level. An 
exploratory analysis was carried out to verify the normality supposition by Shapiro-Wilk. Non-parametric distribution 
was observed for the variables of bone and new bone percentage measurements; however, biomaterial data was 
classified with a Gaussian distribution. Thus, Mann-Whitney and T-test were applied for intergroup comparisons, 
Plot software was used for statistical analysis.