Clinical Trial

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

Active, Not Recruiting
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Summary
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.
Trial Details
NCT Number NCT07294287
Lead Sponsor Tanta University
Conditions Gingiva, Dental Implants
Enrollment 20 participants
Start Date 2024-10-05
Primary Completion 2025-12-10 (estimated)
Study Completion 2026-01-05 (estimated)
Updated on ClinicalTrials.gov 2025-12-19