Effects of Epithelialization-enhancing Agents Following Diode Laser-assisted Frenectomy: A Randomized Clinical Trial
14. august 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
45
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Zagreb, Kroatien, 10000
- School of Dental Medicine University of Zagreb
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control group
Patients undergo diode laser-assisted maxillary labial frenectomy without the postoperative application of any topical epithelialization-enhancing agent.
|
|
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Eksperimentel: 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.
|
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.
|
|
Eksperimentel: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Epithelial Maturation Index (MI)
Tidsramme: 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.
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Day 3, Day 7, and Day 14 post-intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Inflammatory Response (Granulocyte Presence Score)
Tidsramme: 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.
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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
|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. februar 2023
Primær færdiggørelse (Faktiske)
5. december 2023
Studieafslutning (Faktiske)
25. januar 2024
Datoer for studieregistrering
Først indsendt
14. august 2026
Først indsendt, der opfyldte QC-kriterier
14. august 2026
Først opslået (Faktiske)
19. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 02-996/3
Plan for individuelle deltagerdata (IPD)
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INGEN
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