NCT07294287

Impact of Microneedling on the Gingival Tissue Surrounding Implant Supported Fixed Restoration.

Active, enrolled NA Last updated 19 December 2025

What this trial tests

NA trial testing Microneedling Combined with Accelerated Growth Factor (AGF) in Gingiva in 20 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

5 October 2024

Primary endpoint
10 December 2025

5 January 2026

Quick facts

Lead sponsor	Tanta University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	5 October 2024
Primary completion	10 December 2025
Estimated completion	5 January 2026
Sites	1 location across Egypt

Drugs / interventions tested

• Microneedling Combined with Accelerated Growth Factor (AGF)
• Accelerated Growth Factor (AGF) Injection Only

Conditions studied

• Gingiva — all drugs for Gingiva →
• Dental Implants — all drugs for Dental Implants →

Sponsor

Tanta University

Who can join

Adults 18 to 34, any sex, with Gingiva or Dental Implants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized clinical trial aims to evaluate the effect of microneedling with and without accelerated growth factor (AGF) injection on gingival tissue surrounding implant-supported fixed restorations. The peri-implant soft tissue phenotype is an important determinant of long-term implant stability and esthetic success. Patients with thin gingival biotype are more susceptible to mucosal recession, soft tissue transparency, and peri-implant complications. Enhancing gingival thickness and keratinized tissue width using minimally invasive methods can improve esthetic and biological outcomes.

Microneedling has recently been proposed as a simple and minimally invasive approach that stimulates local healing by inducing controlled micro-injury. It triggers angiogenesis and the release of intrinsic growth factors that promote soft tissue regeneration. Accelerated Growth Factor (AGF) is an autologous platelet concentrate obtained through a single-step centrifugation technique. It contains a high concentration of platelet-derived and vascular growth factors that enhance tissue repair and collagen synthesis. Combining microneedling with AGF may therefore produce synergistic effects, improving the soft tissue phenotype and peri-implant mucosal stability.

The study will include 20 participants aged 18-34 years with thin gingival biotype (0.8-1 mm) around maxillary anterior implants. Participants will be randomly assigned to one of two groups:

1. AGF group: AGF injection alone.
2. Microneedling + AGF group: Microneedling using sterile disposable lancets until pinpoint bleeding occurs, followed by AGF injection (0.2-0.3 mL per site).

Clinical parameters including gingival thickness (GT), keratinized tissue width (KTW), probing depth (PD), and bleeding index (BI) will be recorded at baseline, 3 months, and 6 months. All participants will receive standardized zirconia restorations following osseointegration. Statistical analysis will include intra- and inter-group comparisons, with significance set at p \< 0.05.

The study is expected to clarify whether combining microneedling with AGF enhances peri-implant soft tissue thickness more effectively than AGF alone. If successful, this combined minimally invasive approach may offer a practical and biologically based technique to improve soft tissue health and esthetics around dental implants.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.