NCT07750756

Brief 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
19mo left

Started Oct 2026

Status
not yet 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

First Submitted

Initial submission to the registry

August 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

October 30, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

August 2, 2026

Last Update Submit

August 2, 2026

Conditions

Keywords

microneedlinghyaluronic acidI-PRFgingival thicknessperi-implant

Outcome Measures

Primary Outcomes (1)

  • Peri-implant gingival thickness

    6 months

Study Arms (3)

Microneedling

NO INTERVENTION

microneedling into the peri-implant soft tissue site

Microneedling with Hyaluronic Acid (HA)

EXPERIMENTAL

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)

Microneedling with injectable platelet rich fibrin (I-PRF)

EXPERIMENTAL

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.

Microneedling with Hyaluronic Acid (HA)

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)
Microneedling with injectable platelet rich fibrin (I-PRF)

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Hyaluronic Acidproliferation regulatory factors, human urine

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Doaa A. Khattab, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Student

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 6, 2026

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

May 30, 2028

Last Updated

August 6, 2026

Record last verified: 2026-08