Advanced Platelet-rich Fibrin Combined With Open Debridem... | NCT05730153

Studies
Advanced Platelet-rich Fibrin Combined With Open Debridement in Management of Suprabony Periodontal Defects

NCT05730153

Sponsor

October University for Modern Sciences and Arts

Status

Completed

Last Update Posted

Mar 27, 2023Actual

Enrollment

30Actual

Phase

Phase 4

Conditions

Periodontitis, Adult

Interventions

advanced PRF

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

Feb 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

Nov 21, 2021Actual

Primary Completion Date

Jan 27, 2022Actual

Completion Date

Jul 26, 2022Actual

First Submitted Date

Feb 7, 2023

First Submission Date that Met QC Criteria

Feb 7, 2023

First Posted Date

Feb 15, 2023Actual

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 23, 2023

Last Update Posted Date

Mar 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Naglaa Elwakeel, professor, October University for Modern Sciences and ArtsPrincipal Investigator

Lead Sponsor

October University for Modern Sciences and ArtsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

in this clinical trial, patients with periodontal defects will be treated with advanced platelet-rich fibrin in conjunction with open debridement

Detailed Description

two groups of patients with suprabony defects, one will be treated with advanced platelet-rich fibrin in conjunction with open debridement and the other will be treated with open debridement alone. subjects will be evaluated for evidence of bone formation after 6 months of therapy

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1	Active Comparator		Biological: advanced PRF
group 2	Sham Comparator		Biological: advanced PRF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
advanced PRF	Biological	advanced PRF+ surgery	group 1 group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical evaluation	Rate of probing pocket depth reduction	6 months

Secondary Outcomes

Measure	Description	Time Frame
radiographic evaluation	Rate of bone formation by digital radiography	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with periodontal suprabony defects.

Exclusion Criteria:

pregnant females.
smokers.
systemic disease that contraindicate surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

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
Al-Azhar University, Faculty of Dentistry		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D055113	Chronic Periodontitis

Ancestor Terms

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided