Volumetric Changes and Graft Stability in Lateral Window Sinus Augmentation: A Prospective Clinical Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the stability and volumetric changes of the grafting materials used for lateral window sinus augmentation. In addition, different variables known to affect bone stability and remodeling with regard to the augmentation procedure will be evaluated. Similarly, implant placement will be performed and results will be evaluated after a period of six months.

Detailed Description
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This will be a prospective clinical study evaluating the stability and volumetric change of two grafting materials used in lateral window sinus augmentation procedure (anorganic bovine bone xenograft alone compared to a mixture of allograft and anorganic bovine bone xenograft). Participants will have the same surgical treatment of the lateral window sinus augmentation procedure. Participants will have a simultaneous implant placement at the time of sinus augmentation procedure or a delayed implant placement based on the stability of the implant evaluation. Cone beam computed tomography (CBCT) will be used to evaluate the volumetric changes between two groups of graft material in sinus augmentation procedure at three time points: pre-operatively, two weeks post-operation and six months post-operation. Biopsies will be harvested after six months for histological and histomorphometric analysis.

Official Title
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Volumetric Changes and Graft Stability in Lateral Window Sinus Augmentation: A Prospective Clinical Trial

Conditions
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Lateral Window Sinus Augmentation

Intervention / Treatment
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* Device: Allograft bone alone
* Device: Allograft and xenograft mixture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients ≥ 18 years old In need of sinus augmentation utilizing lateral window sinus technique Presence of bone height of < 8 mm Patient has good oral hygiene (<40% plaque score) Periodontally stable Willingness to fulfill all study requirements Exclusion Criteria: Currently smoking > 10 cigarettes / day Pregnant, expecting to become pregnant or lactating mothers Uncontrolled Diabetes Mellitus (HbA1c >7) Medical condition that may influence the outcome (Neurologic or psychiatric disorders, systemic infections) Current use of oral bisphosphonates History of IV bisphosphonates use Poor oral hygiene (plaque score >40% based on O'Leary plaque score) Unmanageable Sinus perforations Significant pathology in the region of interest that may compromise the procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allograft bone alone<br> | Device: Allograft bone alone<br>* The subject will receive an allograft as graft material of choice for sinus augmentation<br>|
| Experimental: Allograft and xenograft mixture<br> | Device: Allograft and xenograft mixture<br>* The subjects will receive a mixture of allograft and anorganic bovine bone xenograft as graft material of choice for sinus augmentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft volumetric stability change | CBCT will be the primary tool to evaluate the volumetric stability of the graft material used in the sinus augmentation procedure | CBCT taken at 2 weeks after the procedure and 6 months after the procedure of sinus augmentation to assess the volumetric changes of the graft material | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histomorphometric analysis | Identify histological differences between two groups of graft material in sinus augmentation procedure | After 6 months of sinus augmentation procedure when the implant is placed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral window approach, Sinus augmentation, Volumetric change, Bone graft