Lateral Sinus Augmentation Utilizing Bovine Bone Mixed wi... | NCT06810921

Studies
Lateral Sinus Augmentation Utilizing Bovine Bone Mixed with Platelet-rich Fibrin

NCT06810921

Sponsor

University of Baghdad

Status

Completed

Last Update Posted

Feb 6, 2025Actual

Enrollment

34Actual

Phase

Early Phase 1

Conditions

Lateral Sinus Lifting

Interventions

lateral sinus lift

Countries

Iraq

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

Jan 2025

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

Jan 13, 2023Actual

Primary Completion Date

Mar 20, 2024Actual

Completion Date

Aug 1, 2024Actual

First Submitted Date

Jan 27, 2025

First Submission Date that Met QC Criteria

Feb 1, 2025

First Posted Date

Feb 6, 2025Actual

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

Feb 1, 2025

Last Update Posted Date

Feb 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

NIBRAS HAMDAN CHASIB BAIDHANI, lecturer at University of Baghdad, University of BaghdadPrincipal Investigator

Lead Sponsor

University of BaghdadOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background:

In sinus augmentation procedure, graft resorption remains a major dilemma of various graft materials.

Objective:

To estimate the graft volume changes following lateral sinus augmentation utilizing cone beam computed tomography.

Methods: A total of 34 lateral sinus augmentation operations were performed and 50 dental implants were concomitantly inserted. The sinus augmentation cases were distributed randomly into 3 groups according to graft material: Group A comprised utilizing deproteinized bovine bone alone, group B using deproteinized bovine bone mixed with leukocyte and platelet-rich fibrin, and group C employing deproteinized bovine bone mixed with advanced platelet-rich fibrin. Cone-beam computed tomography was obtained 2 weeks (baseline record) and 24 weeks postoperatively for the measurement of the graft volume changes.

Detailed Description

Not provided

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
utilizing bovine bone mixed with PRF for sinus lifting	Active Comparator		Procedure: lateral sinus lift

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lateral sinus lift	Procedure	A rectangular shaped osteotomy was performed using a low-speed surgical handpiece and round diamond bur, with copious cooled normal saline irrigation. The Schneiderian membrane (SM) was gently elevatated using Frios Sinus Set elevators for implant placement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of graft volume changes based on CBCT imaging		24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

requiring lateral sinus lift for implant placement

Exclusion Criteria:

available bone permits implant placement without need for sinus lifting

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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
College of Dentistry		Bab Al Muadham	Baghdad Governorate	10047	Iraq

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided