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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
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.
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.
School of Dental Medicine University of Zagreb
Zagreb, Croatia
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.
Time frame: Day 3, Day 7, and Day 14 post-intervention
Inflammatory Response (Granulocyte Presence Score)
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.
Time frame: Day 3, Day 7, and Day 14 post-intervention
Re-Epithelialization
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.
Time frame: Day 3, Day 7, and Day 14 post-intervention
Clinical Wound Healing and Complications
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.
Time frame: Day 3, Day 7, and Day 14 post-intervention
Preoperative Patient Fear Score
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).
Time frame: Immediately prior to surgical intervention
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