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ACTIVE NOT RECRUITING
NCT07294287
NA

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

Sponsor: Tanta University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 34 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-10-05

Completion Date

2026-01-05

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

PROCEDURE

Microneedling Combined with Accelerated Growth Factor (AGF)

Participants in this arm received microneedling around the peri-implant mucosa in the maxillary anterior region using sterile disposable glucometer lancets under aseptic conditions. Repeated micro-perforations were created circumferentially until pinpoint bleeding appeared. Immediately afterward, autologous Accelerated Growth Factor (AGF) was injected (0.2-0.3 mL per site) into the treated mucosa. AGF was prepared from 10 mL of venous blood using a single-step centrifugation protocol to isolate the growth factor-rich fraction. Gingival thickness and soft tissue parameters were assessed using an intraoral scanner combined with a transgingival file measurement technique at baseline, 3 months, and 6 months.

PROCEDURE

Accelerated Growth Factor (AGF) Injection Only

Participants in this arm received autologous Accelerated Growth Factor (AGF) injection alone into the peri-implant mucosa (0.2-0.3 mL per site) in the maxillary anterior region, without prior microneedling. The AGF was prepared from 10 mL of venous blood via a standardized single-step centrifugation procedure to obtain a growth factor-rich fraction. Gingival thickness and soft tissue parameters were evaluated using the same intraoral scanner and transgingival file method at baseline, 3 months, and 6 months

Locations (1)

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, Egypt