Frenulectomy
Conditions
Keywords
lasers, oral frenectomy, epithelization, hyaluronic acid
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.
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.
Interventions
DEVICEHyaluronic 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.
DEVICEBioactive 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
University of Zagreb
Ss. Cyril and Methodius University of Skopje
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epithelial Maturation Index (MI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Response (Granulocyte Presence Score) | 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. |
| Re-Epithelialization | 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. |
| Clinical Wound Healing and Complications | 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. |
| Preoperative Patient Fear Score | 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). |
Countries
Croatia
Outcome results
None listed