Clinical Evaluation of Microneedling With Silymarin for Gingival Depigmentation: Regulatory Perspective on a Three Arm Comparison Including Diode Laser and Scalpel

This report examines a three arm gingival depigmentation trial evaluating conventional methods, diode laser and microneedling with topical silymarin, with regulatory considerations for future practice.

The clinical trial record identified as NCT07410156 is sponsored by Fayoum University and aims to compare three depigmentation procedures for gingival hyperpigmentation. The study is listed as recruiting as of February 15, 2026, and the source provides the intervention arms and sponsor information, along with a link to the ClinicalTrials.gov record for full details.

What changed in gingival depigmentation approaches?

The record shows that three distinct depigmentation approaches are evaluated. The conventional method relies on scalpel based tissue removal. The diode laser method uses a laser device to ablate pigmented gingival tissue. The microneedling arm combines controlled skin perforation with topical silymarin application to address hyperpigmentation. The combination of microneedling with a topical drug introduces a mixed device and drug approach, which may influence regulatory classification and needed safety data. The narrative presented here is limited to the trial description and sponsor claims in the source text; no results are reported in the source.

Which methods are being compared in the trial?

Conventional depigmentation method

The conventional approach is described as gingival depigmentation with a scalpel as the procedural method. This arm serves as the baseline comparator in the trial design.

Diode laser depigmentation

The diode laser arm uses a laser device to remove pigmented gingival tissue, representing a device based therapeutic option often used in dental procedures. The trial contrasts this method with the other arms.

Microneedling with topical silymarin

The third arm applies microneedling followed by topical silymarin to gingival tissues with hyperpigmentation. This combination implies exposure to a drug substance in conjunction with a physical modality, a factor that may influence regulatory classification and safety evidence requirements.

What is the trial context and regulatory relevance?

According to the source text, the trial is sponsored by Fayoum University and is listed on ClinicalTrials.gov with the study identifier NCT07410156. The record states that recruitment is ongoing. The presence of three arms provides a comparative framework that can inform clinical practice and potential regulatory pathways for depigmentation procedures. Readers should note that the source does not report outcomes, efficacy data or safety results. For full details, the ClinicalTrials.gov page is linked in the source text.

What safety and regulatory considerations apply?

From a regulatory perspective, the trial description supports an evaluation of procedural safety and any device or drug complications associated with the three methods. The conventional scalpel method and diode laser approach are established dental procedures with known safety profiles in standard practice, while microneedling with topical silymarin introduces a drug component in combination with a mechanical modality. This combination may affect classification, required preclinical data, and the design of future trials. The article clarifies that the information presented is limited to a trial description and sponsor details rather than study results.