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

August 14, 2026 updated by: Roko Bjelica, University of Zagreb
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diode lasers are widely utilized in soft tissue oral surgery due to their precise cutting, intraoperative decontamination, and minimal bleeding; however, thermal damage can sometimes lead to delayed secondary-intention epithelialization. This randomized clinical study investigates whether adjunctive topical application of hyaluronic acid gel or micronutrient gel accelerates mucosal regeneration and reduces inflammatory response following high-power diode laser frenectomy (975 nm, 4W). Clinical parameters (hyperemia, edema, bleeding, fibrinous adhesion) and semi-quantitative cytological markers (granulocytes, erythrocytes, epithelial cells, stromal cells, and Maturation Index) are longitudinally analyzed at Days 3, 7, and 14 post-intervention.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • School of Dental Medicine University of Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 7 and 18 years
  • Low insertion / attachment of the maxillary labial frenum requiring surgical excision
  • Presence of maxillary midline diastema associated with the frenum
  • Complete eruption of permanent maxillary central incisors
  • Good systemic health
  • Good oral health
  • Written informed consent signed by the patient and/or parent/legal guardian prior to enrollment

Exclusion Criteria:

  • Incomplete eruption of permanent maxillary central incisors
  • Presence of systemic diseases or medical conditions that could interfere with wound healing or bone/soft tissue metabolism
  • Active oral infections, extensive untreated caries, or poor periodontal status
  • Known hypersensitivity or allergy to local anesthetics, hyaluronic acid, or any ingredients of the study gels (Miradont®-Gel or Gengigel®)
  • History of previous surgical intervention in the maxillary labial frenum area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients undergo diode laser-assisted maxillary labial frenectomy without the postoperative application of any topical epithelialization-enhancing agent.
Experimental: Miradont-Gel Group
Patients undergo diode laser-assisted maxillary labial frenectomy followed by topical application of Miradont®-Gel (approx. 0.5 ml) to the surgical site three times daily for 14 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.
Experimental: Gengigel Group
Patients undergo diode laser-assisted maxillary labial frenectomy followed by topical application of Gengigel® (hyaluronic acid gel, approx. 0.5 ml) to the surgical site three times daily for 14 days.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epithelial Maturation Index (MI)
Time Frame: Day 3, Day 7, and Day 14 post-intervention
Quantitative assessment of mucosal epithelial differentiation and cellular maturation evaluated by cytological smears from the surgical wound using the standardized Frost method. The index calculates the percentage distribution of basal, parabasal, intermediate, and superficial epithelial cells to determine the degree of tissue regeneration.
Day 3, Day 7, and Day 14 post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory Response (Granulocyte Presence Score)
Time Frame: Day 3, Day 7, and Day 14 post-intervention
Semi-quantitative cytological assessment of inflammatory infiltrate in wound smears, scored on a 4-point scale: 0 = absence of granulocytes / clean background; 1 = low presence (≤ 2); 2 = moderate presence (2 < n ≤ 5); 3 = significant presence with tissue detritus (> 5). Lower scores indicate faster resolution of inflammation.
Day 3, Day 7, and Day 14 post-intervention
Re-Epithelialization
Time Frame: Day 3, Day 7, and Day 14 post-intervention
Semi-quantitative cytological score evaluating the density of epithelial cells in wound smears on a 4-point scale: 0 = absence/minimal presence; 1 = low presence (≤ 2); 2 = moderate presence (2 < n ≤ 5); 3 = satisfactory presence (> 5). Higher scores indicate advanced re-epithelialization.
Day 3, Day 7, and Day 14 post-intervention
Clinical Wound Healing and Complications
Time Frame: Day 3, Day 7, and Day 14 post-intervention
Clinical evaluation of secondary-intention wound healing at the surgical site, recording the presence or absence of postoperative hyperemia, edema, postoperative bleeding, and fibrinous deposition.
Day 3, Day 7, and Day 14 post-intervention
Preoperative Patient Fear Score
Time Frame: Immediately prior to surgical intervention
Patient-reported subjective fear and anxiety assessed prior to the procedure using a Visual Analogue Scale (VAS) ranging from 0 (no fear) to 10 (extreme fear), categorized into low (0-3), moderate (4-6), and strong fear (7-10).
Immediately prior to surgical intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zagreb

Collaborators

Ss. Cyril and Methodius University of Skopje

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Actual)

December 5, 2023

Study Completion (Actual)

January 25, 2024

Study Registration Dates

First Submitted

August 14, 2026

First Submitted That Met QC Criteria

August 14, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 02-996/3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe