NCT07280507

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for early_phase_1

Timeline
4mo left

Started Nov 2025

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Nov 2025Sep 2026

Study Start

First participant enrolled

November 24, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

November 26, 2025

Last Update Submit

December 9, 2025

Conditions

Papilla Reconstruction

Keywords

PapillaReconstructionHyaluronic AcidInjectable Platelet Rich FibrinMicroneedling

Outcome Measures

Primary Outcomes (2)

  • Papillary height

    from the mucogingival junction to the papilla tip

    Baseline, 6 weeks, and 12 weeks.

  • Papillary width

    12 weeks

Study Arms (2)

HA

EXPERIMENTAL

Hyaluronic Acid Filler

Other: Hyaluronic Acid (HA)

iPRF

ACTIVE COMPARATOR
Biological: Injectable Platelet Rich Fibrin

Interventions

Injectable Platelet Rich FibrinBIOLOGICAL

Injectable Platelet Rich Fibrin

iPRF
Hyaluronic Acid (HA)OTHER

Filler

HA

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King AbdulAziz University

Jeddah, Saudi Arabia

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 12, 2025

Study Start

November 24, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
March 2026- March 2027.

Locations

SA(1)