Hyaluronic Acid vs I-PRF With Microneedling in Enhancing Peri-implant Soft Tissue

August 14, 2026 updated by: Rahaf Medhat Zayn, Ain Shams University

Hyaluronic Acid Versus I-PRF Combined With Microneedling for Peri Implant Soft Tissue Enhancement: A Randomized Controlled Clinical Trial

This study aims to compare the use of microneedling alone versus with hyaluronic acid or i-PRF in conjunction with microneedling in peri-implant mucosa in the esthetic zone to test the superior increase in gingival thickness.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Despite the rising demand for esthetics and the prevailing use of dental implants in the recent era, the soft tissue remains a dilemma that affects patients' satisfaction and the implants' longevity in the oral environment, especially in the esthetic region of the maxilla. Various studies have been done to test the effectiveness of microneedling, hyaluronic acid, and i-PRF as alternative non-invasive or minimally invasive methods targeting tissue enhancement in the gingiva, and have proven that they have notable and desirable results. However, there is a lack in the literature regarding the use of these previously mentioned treatment options with regard to peri-implant soft tissue, and which of the delivered solutions offers superior results with reference to peri-implant mucosa in conjunction with microneedling.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

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:

  • Patients with delayed implants placed in the maxillary esthetic region in correct positioning and angulation
  • Patients with peri-implant gingival thickness ≤ 1 mm
  • Patients with healthy gingiva and who can maintain good oral hygiene around implants

Exclusion Criteria:

  • Marginal bone loss ≤ 2 mm
  • Patients with peri-implantitis or periodontitis
  • Patients with systemic conditions or diseases impairing healing or soft tissue metabolism
  • Pregnant or lactating females
  • Patients taking medications affecting the gingiva

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Microneedling
microneedling into the peri-implant soft tissue site
Experimental: Microneedling with Hyaluronic Acid (HA)
Microneedling into the peri-implant soft tissue site in addition to the use of HA, repeated 3 times with 7 days gap in between.
Drug: Hyaluronic Acid (HA)
Hyaluronic acid (HA) is a genuine linear glycosaminoglycan that is present within the extracellular matrix of connective, epithelial, and neural tissues.
Experimental: Microneedling with injectable platelet rich fibrin (I-PRF)
Microneedling into the peri-implant soft tissue site, in addition to the use of I-PRF, repeated 3 times with 7 days gap in between.
Biological: Platelet rich fibrin
Injectable PRF (i-PRF) is a notable method in enhancing soft tissue phenotypes, relying on its injectable form that can be well delivered to targeted areas to ensure proper distribution of growth factors and cytokines.
Other Names:
  • (I-PRF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peri-implant gingival thickness
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Chair: Doaa A. Khattab, Associate Professor, Ain Shams Univeristy
  • Study Director: Suzan Sarhan, Associate Professor, Ain shams 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 (Estimated)

October 30, 2026

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

August 2, 2026

First Submitted That Met QC Criteria

August 2, 2026

First Posted (Actual)

August 6, 2026

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1673

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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