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

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.

Study Overview

• Status: Completed
• Conditions: Lateral Window Sinus Augmentation
• Intervention / Treatment: Device: Allograft bone alone; Device: Allograft and xenograft mixture

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • University of Oklahoma Graduate Periodotics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allograft bone alone	Device: Allograft bone alone; The subject will receive an allograft as graft material of choice for sinus augmentation
Experimental: Allograft and xenograft mixture	Device: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): April 24, 2019
• Study Completion (Actual): September 9, 2020

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Bone graft; Sinus augmentation; Lateral window approach; Volumetric change
• Other Study ID Numbers: 9302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not decided yet if there will be a possibility to publish the study in a journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes