Comparing Microneedling and Injectable Platelet Rich Fibrin to Hyaluronic Acid In Papilla Reconstruction ((PRF) (HA))

December 9, 2025 updated by: Amal Jamjoom, BDS, MS., King Abdulaziz University

Comparative Evaluation of Microneedling With Injectable PRF and Hyaluronic Acid for Papilla Reconstruction: A Randomized Clinical Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

7

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • King Abdulaziz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HA
Hyaluronic Acid Filler
Other: Hyaluronic Acid (HA)
Filler
Active Comparator: iPRF
Biological: Injectable Platelet Rich Fibrin
Injectable Platelet Rich Fibrin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 117-10-24 (Other Identifier: King AbdulAziz University)
  • King AbdulAziz University (Other Identifier: King AbdulAziz University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

March 2026- March 2027.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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