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

NCT ID: NCT07280507

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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Papilla Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HA

Hyaluronic Acid Filler

Group Type EXPERIMENTAL

Hyaluronic Acid (HA)

Intervention Type OTHER

Filler

iPRF

Group Type ACTIVE_COMPARATOR

Injectable Platelet Rich Fibrin

Intervention Type BIOLOGICAL

Injectable Platelet Rich Fibrin

Interventions

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Injectable Platelet Rich Fibrin

Injectable Platelet Rich Fibrin

Intervention Type BIOLOGICAL

Hyaluronic Acid (HA)

Filler

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdulaziz University

OTHER

Sponsor Role lead

Responsible Party

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Amal Jamjoom, BDS, MS.

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King AbdulAziz University

Jeddah, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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117-10-24

Identifier Type: REGISTRY

Identifier Source: secondary_id

117-10-24

Identifier Type: OTHER

Identifier Source: secondary_id

King AbdulAziz University

Identifier Type: OTHER

Identifier Source: secondary_id

117-10-24

Identifier Type: -

Identifier Source: org_study_id

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