Comparing Microneedling and Injectable Platelet Rich Fibr... | NCT07280507

Studies
Comparing Microneedling and Injectable Platelet Rich Fibrin to Hyaluronic Acid In Papilla Reconstruction

NCT07280507

Sponsor

King Abdulaziz University

Status

Active, not recruiting

Last Update Posted

Dec 12, 2025Actual

Enrollment

7Estimated

Phase

Early Phase 1

Conditions

Papilla Reconstruction

Interventions

Injectable Platelet Rich Fibrin
Hyaluronic Acid (HA)

Countries

Saudi Arabia

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
117-10-24	Registry Identifier	117-10-24
117-10-24	Other Identifier	King AbdulAziz University
King AbdulAziz University	Other Identifier	King AbdulAziz University

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 24, 2025Actual

Primary Completion Date

Mar 2026Estimated

Completion Date

Sep 30, 2026Estimated

First Submitted Date

Nov 26, 2025

First Submission Date that Met QC Criteria

Dec 9, 2025

First Posted Date

Dec 12, 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

Dec 9, 2025

Last Update Posted Date

Dec 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This randomized split-mouth clinical trial aims to compare the clinical effectiveness of microneedling combined with injectable platelet-rich fibrin (i-PRF) versus hyaluronic acid (HA) gel injection in the reconstruction of Class I interdental papilla loss. The study hypothesizes that MN + i-PRF will yield greater papillary regeneration, offering a minimally invasive, biologically active alternative to traditional surgical approaches for soft-tissue esthetic rehabilitation.

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

7Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HA	Experimental	Hyaluronic Acid Filler	Other: Hyaluronic Acid (HA)
iPRF	Active Comparator		Biological: Injectable Platelet Rich Fibrin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Injectable Platelet Rich Fibrin	Biological	Injectable Platelet Rich Fibrin	iPRF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Papillary height	from the mucogingival junction to the papilla tip	Baseline, 6 weeks, and 12 weeks.
Papillary width		12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Plaque index <1
Gingival index <1
Class I papillary loss (Nordland and Tarnow classification)
Probing depth ≤4 mm at the test site
Inter-proximal bone crest distance ≤7 mm from the contact point.

Exclusion Criteria:

Pregnancy
Lactation
Uncontrolled systemic diseases (e.g., diabetes)
Anticoagulant therapy
Recent radiotherapy
Orthodontic treatment
Midline diastema
High frenum attachment
Class II/III papillary loss.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 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
King AbdulAziz University		Jeddah			Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

March 2026- March 2027.

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 9, 2025	Dec 9, 2025	Prot_SAP_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D006820	Hyaluronic Acid

Ancestor Terms

ID	Term
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

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