Comparison Between PEEK With Platelet-rich Fibrin and PEE... | NCT06376708

Studies
Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation

NCT06376708

Sponsor

Cairo University

Status

Completed

Last Update Posted

Apr 19, 2024Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Maxillary Sinus

Interventions

platelet rich fibrin
Polyether ether ketone

Countries

Egypt

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

Sep 2023

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

Sep 1, 2022Actual

Primary Completion Date

Mar 1, 2023Actual

Completion Date

Jul 1, 2023Actual

First Submitted Date

Mar 28, 2024

First Submission Date that Met QC Criteria

Apr 17, 2024

First Posted Date

Apr 19, 2024Actual

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

Apr 17, 2024

Last Update Posted Date

Apr 19, 2024Actual

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

comparison between the resulted bone during maxillary sinus elevation by PEEK with and without platelet rich fibrin

Detailed Description

Histomorphometric and clinical analysis of the bone formed after 6 months after the maxillary sinus elevation using PEEK in the 2 groups : the study group (PEEK with platelet rich fibrin) and the control group (PEEK alone ) .

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PEEK and PRF	Experimental	maxillary sinus elevation using PEEK and platelet rich fibrin	Other: platelet rich fibrin Other: Polyether ether ketone
PEEK alone	Active Comparator	maxillary sinus elevation using PEEK alone	Other: Polyether ether ketone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
platelet rich fibrin	Other	platelet rich fibrin	PEEK and PRF	P.R.F

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone quantity	using of CBCT	6 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Bone quality	Histomorphometic analysis (For Core biopsy)	6 months postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Posterior edentulous ridges with pneumatized maxillary sinus and remaining bone height less than 4 mm.
- ASA physical status I and II.
- Patients willing to be a part of the study and ready to give their consent in writing for the same.
- Patient not complain from maxillary sinusitis
- Patient with good oral hygiene.
- Both males as well as females without any active periodontal disease.
- The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
- Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

Exclusion Criteria:

• General contraindications to implant surgery.
- Untreated gingivitis, periodontitis.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Pregnant or nursing.
- Unable to open mouth sufficiently to accommodate the surgical tooling.
- Patients participating in other studies, if the present protocol could not be properly followed.
- Patient who could/would not participate in the follow-up period.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided