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Effects of Epithelialization-enhancing Agents Following Diode Laser-assisted Frenectomy: A Randomized Clinical Trial

NCT07773701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-08-19

No results posted yet for this study

Summary

The purpose of this randomized clinical trial is to evaluate and compare the effects of two topical epithelialization-enhancing agents-a hyaluronic acid-based gel (Gengigel®) and a bioactive micronutrient-based gel (Miradont®-Gel)-versus no topical agent (control) on soft tissue wound healing following diode laser-assisted maxillary labial frenectomy. Pediatric and adolescent patients requiring maxillary labial frenectomy are randomly assigned into three parallel groups:Control Group: Diode laser frenectomy without topical agent application. Miradont® Group: Diode laser frenectomy followed by postoperative application of Miradont®-Gel three times daily for 14 days. Gengigel® Group: Diode laser frenectomy followed by postoperative application of Gengigel® three times daily for 14 days. Postoperative wound healing, re-epithelialization, and cellular maturation are evaluated clinically and cytologically on days 3, 7, and 14 following the surgical intervention.

Conditions

  • Frenulectomy

Interventions

DEVICE

Hyaluronic Acid Gel (Gengigel®)

Topical application of hyaluronic acid gel (approx. 0.5 ml) directly to the laser surgical wound three times daily (after meals and before sleep) for 14 consecutive days.

DEVICE

Bioactive Micronutrient Gel (Miradont®-Gel)

opical application of bioactive micronutrient gel containing vitamins and minerals (approx. 0.5 ml) directly to the laser surgical wound three times daily (after meals and before sleep) for 14 consecutive days.

Sponsors & Collaborators

  • Ss. Cyril and Methodius University of Skopje

    collaborator OTHER

  • University of Zagreb

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2023-12-05
Completion
2024-01-25

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07773701 on ClinicalTrials.gov