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

University of Oklahoma (OU)

Status: Completed

Conditions: Lateral Window Sinus Augmentation

Treatments: Device: Allograft and xenograft mixture; Device: Allograft bone alone

Study type: Interventional

Funder types: Other

Identifiers

NCT03639077

9302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Allograft bone alone

Experimental group

Treatment:

Device: Allograft bone alone

Allograft and xenograft mixture

Experimental group

Treatment:

Device: Allograft and xenograft mixture