Volumetric Changes and Graft Stability in Lateral Window... | NCT03639077

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

NCT03639077

Sponsor

University of Oklahoma

Status

Completed

Last Update Posted

Mar 19, 2024Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Lateral Window Sinus Augmentation

Interventions

Allograft bone alone
Allograft and xenograft mixture

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Apr 24, 2019Actual

Completion Date

Sep 9, 2020Actual

First Submitted Date

Aug 10, 2018

First Submission Date that Met QC Criteria

Aug 16, 2018

First Posted Date

Aug 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2024

Last Update Posted Date

Mar 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Allograft bone alone	Experimental		Device: Allograft bone alone
Allograft and xenograft mixture	Experimental		Device: Allograft and xenograft mixture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Allograft bone alone	Device	The subject will receive an allograft as graft material of choice for sinus augmentation	Allograft bone alone

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Oklahoma Graduate Periodotics		Oklahoma City	Oklahoma	73117	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

It is not decided yet if there will be a possibility to publish the study in a journal.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014184	Transplantation, Homologous

Ancestor Terms

ID	Term
D014180	Transplantation
D013514	Surgical Procedures, Operative

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