Effects of Epithelialization-enhancing Agents Following Diode Laser-assisted Frenectomy: A Randomized Clinical Trial
14. august 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
45
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Zagreb, Kroatia, 10000
- School of Dental Medicine University of Zagreb
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Control group
Patients undergo diode laser-assisted maxillary labial frenectomy without the postoperative application of any topical epithelialization-enhancing agent.
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Eksperimentell: 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.
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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.
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Eksperimentell: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Epithelial Maturation Index (MI)
Tidsramme: Day 3, Day 7, and Day 14 post-intervention
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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.
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Day 3, Day 7, and Day 14 post-intervention
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Inflammatory Response (Granulocyte Presence Score)
Tidsramme: Day 3, Day 7, and Day 14 post-intervention
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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.
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Day 3, Day 7, and Day 14 post-intervention
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Re-Epithelialization
Tidsramme: Day 3, Day 7, and Day 14 post-intervention
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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.
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Day 3, Day 7, and Day 14 post-intervention
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Clinical Wound Healing and Complications
Tidsramme: Day 3, Day 7, and Day 14 post-intervention
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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.
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Day 3, Day 7, and Day 14 post-intervention
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Preoperative Patient Fear Score
Tidsramme: Immediately prior to surgical intervention
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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).
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Immediately prior to surgical intervention
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Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
6. februar 2023
Primær fullføring (Faktiske)
5. desember 2023
Studiet fullført (Faktiske)
25. januar 2024
Datoer for studieregistrering
Først innsendt
14. august 2026
Først innsendt som oppfylte QC-kriteriene
14. august 2026
Først lagt ut (Faktiske)
19. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 02-996/3
Plan for individuelle deltakerdata (IPD)
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NEI
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