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

Lateral Window Sinus Augmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03639077
• Other study ID #: 9302
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 9, 2020

Study information

• Verified date: March 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 9, 2020
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lateral Window Sinus Augmentation

Intervention

Device:
• Allograft bone alone
The subject will receive an allograft as graft material of choice for sinus augmentation
• Allograft and xenograft mixture
The subjects will receive a mixture of allograft and anorganic bovine bone xenograft as graft material of choice for sinus augmentation

Locations

Country	Name	City	State
United States	University of Oklahoma Graduate Periodotics	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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