Clinical trial NCT03639077: Volumetric Changes and Graft Stability in Lateral Window Sinus Augmentation: A Prospective Clinical Trial
Official title: Volumetric Changes and Graft Stability in Lateral Window Sinus Augmentation: A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Window Sinus Augmentation
Keywords: Bone graft
Lateral window approach
Sinus augmentation
Volumetric change
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients ≥ 18 years old
2. In need of sinus augmentation utilizing lateral window sinus technique
3. Presence of bone height of \< 8 mm
4. Patient has good oral hygiene (\<40% plaque score)
5. Periodontally stable
6. Willingness to fulfill all study requirements

Exclusion Criteria:

1. Currently smoking \> 10 cigarettes / day
2. Pregnant, expecting to become pregnant or lactating mothers
3. Uncontrolled Diabetes Mellitus (HbA1c \>7)
4. Medical condition that may influence the outcome (Neurologic or psychiatric disorders, systemic infections)
5. Current use of oral bisphosphonates
6. History of IV bisphosphonates use
7. Poor oral hygiene (plaque score \>40% based on O'Leary plaque score)
8. Unmanageable Sinus perforations
9. Significant pathology in the region of interest that may compromise the procedure

Primary outcomes:
measure: Graft volumetric stability change
timeFrame: 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 outcomes:
measure: Histomorphometric analysis
timeFrame: After 6 months of sinus augmentation procedure when the implant is placed
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Graduate Periodotics
state: Oklahoma
Study officials:
References: