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

NCT07773701 | Completed

• 1 other identifier: 02-996/3
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lasers; oral frenectomy; epithelization; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Epithelial Maturation Index (MI)

  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 Outcomes (4)

• Inflammatory Response (Granulocyte Presence Score)

  Day 3, Day 7, and Day 14 post-intervention

• Re-Epithelialization

  Day 3, Day 7, and Day 14 post-intervention

• Clinical Wound Healing and Complications

  Day 3, Day 7, and Day 14 post-intervention

• Preoperative Patient Fear Score

  Immediately prior to surgical intervention

Study Arms (3)

Control group

NO INTERVENTION

Patients undergo diode laser-assisted maxillary labial frenectomy without the postoperative application of any topical epithelialization-enhancing agent.

Miradont-Gel Group

EXPERIMENTAL

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)

Gengigel Group

EXPERIMENTAL

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®)

Interventions

Hyaluronic Acid Gel (Gengigel®) DEVICE

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.

Gengigel Group

Bioactive Micronutrient Gel (Miradont®-Gel) DEVICE

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.

Miradont-Gel Group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zagreb: lead
• Ss. Cyril and Methodius University of Skopje: collaborator

Study Sites (1)

School of Dental Medicine University of Zagreb

Zagreb, 10000, Croatia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMD PhD

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: February 6, 2023
• Primary Completion: December 5, 2023
• Study Completion: January 25, 2024
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)