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Not yet recruitingNCT07750756Updated Aug 17, 2026

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

A Phase 2/3 interventional study of Hyaluronic Acid (HA) and Platelet rich fibrin in Peri-implant Mucosa Thickness, sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment

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Phase
Phase 2/3
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Peri-implant Mucosa Thickness

Keywords

  • microneedling
  • hyaluronic acid
  • I-PRF
  • gingival thickness
  • peri-implant
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,954 studies on the registry; 430 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • 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)

  • 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

Interventions

  • Hyaluronic acid (HA) is a genuine linear glycosaminoglycan that is present within the extracellular matrix of connective, epithelial, and neural tissues.

  • 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.

    Also known as: (I-PRF)

06

What researchers measure

Primary outcomes

  1. Peri-implant gingival thickness

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Feb 2028, 15 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2026
First posted
Aug 6, 2026
StartEst.
Oct 30, 2026
Primary completionEst.
Feb 28, 2028
CompletionEst.
May 30, 2028
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07750756
Responsible party
Rahaf Medhat Zayn (Principal investigator, Ain Shams University) — Principal investigator
First posted
Aug 6, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Feb 28, 2028 (estimated)
Completion
May 30, 2028 (estimated)
Last update
Aug 17, 2026

Study contacts

Rahaf A. Khattab, Principal investigator
Contact
RahafZayn@dent.asu.edu.eg
+201120008982
Doaa A. Khattab, Associate Professor
Contact
doaadel12345@yahoo.com
+201006814258
Doaa A. Khattab, Associate Professor
study chair · Ain Shams Univeristy
Suzan Sarhan, Associate Professor
study director · Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Hyaluronic Acid · P-prf

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