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970-nm Diode Laser Versus Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy (MLF-DL-KRYO)

13. juli 2026 oppdatert av: Kutahya Health Sciences University

Comparison of Salivary Cortisol Response and Early Postoperative Outcomes Following 970-nm Diode Laser and Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy: A Randomized Single-Blind Clinical Trial

This prospective, randomized, single-blind, assessor-blinded, parallel-group clinical trial aims to compare the effects of 970-nm diode laser and liquid nitrogen cryotherapy in patients requiring maxillary labial frenectomy.

The primary objective is to compare the change in salivary cortisol levels from baseline to postoperative day 2 between the two treatment groups. Secondary objectives include comparison of postoperative pain, edema, interincisal mouth opening, analgesic consumption, operation duration, state anxiety, clinical wound healing, and adverse events.

Eligible adult patients with an indication for maxillary labial frenectomy will be randomly assigned to receive either 970-nm diode laser frenectomy or liquid nitrogen cryotherapy. Salivary cortisol samples and clinical outcomes will be assessed during the early postoperative follow-up period.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Maxillary labial frenulum abnormalities may be associated with diastema, plaque accumulation, periodontal irritation, gingival recession, oral hygiene difficulty, functional discomfort, and esthetic concerns. Frenectomy may be indicated when the frenulum is hypertrophic, short, thick, or inserted close to the interdental papilla.

Conventional scalpel frenectomy is effective but may be associated with intraoperative bleeding, need for suturing, postoperative pain, edema, and reduced patient comfort. Minimally invasive approaches such as diode laser surgery and cryotherapy may offer potential advantages in oral soft tissue procedures.

This study will compare two minimally invasive approaches for maxillary labial frenectomy: 970-nm diode laser and liquid nitrogen cryotherapy. Participants will be randomized into two parallel groups. In the diode laser group, frenectomy will be performed using a 970-nm diode laser at 2 W in continuous wave mode with a 320-micrometer sterile fiber tip using a contact technique. In the liquid nitrogen cryotherapy group, open-spray cryotherapy will be applied to the maxillary labial frenulum region with two freeze-thaw cycles.

The primary endpoint is the change in salivary cortisol level from baseline to postoperative day 2. Secondary endpoints include postoperative day 7 salivary cortisol change, postoperative pain measured by visual analog scale, edema, interincisal mouth opening, total analgesic consumption, operation duration, State-Trait Anxiety Inventory-State score, Landry, Turnbull and Howley wound healing index scores, and postoperative complications or adverse events.

All procedures and salivary sampling will be standardized and performed in the morning to reduce the influence of circadian variation on cortisol measurements. The study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kutahya Health Sciences University.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
    • Kütahya
      • Kütahya, Kütahya, Tyrkia (Türkiye), 43020
        • Kütahya Health Sciences University Faculty of Dentistry
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Muhammet Yasin Pektaş, Asst. Prof., DDS

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Age between 18 and 65 years.
  • Systemically healthy, ASA I status.
  • Clinical indication for maxillary labial frenectomy.
  • Ability to attend postoperative follow-up visits.
  • Provision of written informed consent.

Exclusion Criteria:

  • Systemic or local corticosteroid use within the last 6 months.
  • Endocrine disease that may affect cortisol levels.
  • Pregnancy or lactation.
  • Active oral infection.
  • Chronic analgesic or anti-inflammatory drug use.
  • Psychiatric medication use.
  • Smoking.
  • ASA II or higher systemic status.
  • Inability to attend follow-up visits.
  • Refusal to participate in the study.

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
Eksperimentell: 970-nm Diode Laser Frenectomy
Participants randomized to this arm will undergo maxillary labial frenectomy using a 970-nm diode laser. The procedure will be performed with a SiroLaser Advance device at 970 nm wavelength, 2 W power, continuous wave mode, and a 320-micrometer sterile fiber tip using a contact technique. The total laser application time will be standardized as 2 minutes. The surgical area will not be sutured and will be left to heal by secondary intention.
Fremgangsmåte: 970-nm Diode Laser Frenectomy
Maxillary labial frenectomy will be performed using a 970-nm diode laser device at 2 W power in continuous wave mode with a 320-micrometer sterile fiber tip using a contact technique. The total laser application time will be standardized as 2 minutes. The surgical area will not be sutured and will be left to heal by secondary intention.
Andre navn:
  • Diode laser frenectomy
Eksperimentell: Liquid Nitrogen Cryotherapy
Participants randomized to this arm will receive liquid nitrogen cryotherapy applied to the maxillary labial frenulum region using an open-spray technique. Two freeze-thaw cycles will be performed; each freezing cycle will last 15 seconds, with passive complete thawing between cycles. No mechanical excision will be performed after cryotherapy. The target tissue is expected to be eliminated through cryogenic necrosis and secondary healing. The surgical area will not be sutured.
Fremgangsmåte: Liquid Nitrogen Cryotherapy
Liquid nitrogen cryotherapy will be applied to the maxillary labial frenulum region using an open-spray technique. Two freeze-thaw cycles will be performed; each freezing cycle will last 15 seconds, with passive complete thawing between cycles. No mechanical excision will be performed after cryotherapy, and the surgical area will not be sutured.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in salivary cortisol level from baseline to postoperative day 2
Tidsramme: Baseline and postoperative day 2
Salivary cortisol will be measured in unstimulated saliva samples using an ELISA method. For each participant, the change in salivary cortisol level from the preoperative baseline measurement to postoperative day 2 will be calculated and compared between the two intervention groups. Results will be recorded in nmol/L.
Baseline and postoperative day 2

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in salivary cortisol level from baseline to postoperative day 7
Tidsramme: Baseline and postoperative day 7
Salivary cortisol will be measured in unstimulated saliva samples using an ELISA method. For each participant, the change in salivary cortisol level from the preoperative baseline measurement to postoperative day 7 will be calculated and compared between the two intervention groups. Results will be recorded in nmol/L.
Baseline and postoperative day 7
Change in postoperative edema
Tidsramme: Baseline, postoperative day 2, and postoperative day 7
Postoperative edema will be assessed using standardized facial measurements. Changes in edema measurements from baseline to postoperative day 2 and postoperative day 7 will be calculated and compared between the two intervention groups.
Baseline, postoperative day 2, and postoperative day 7
Postoperative pain intensity
Tidsramme: Postoperative 6 hours, 12 hours, 24 hours, day 2, and day 7
Postoperative pain intensity will be assessed using a 0-to-10 visual analog scale, where higher scores indicate greater pain intensity.
Postoperative 6 hours, 12 hours, 24 hours, day 2, and day 7
Change in interincisal mouth opening
Tidsramme: Baseline, postoperative day 2, and postoperative day 7
Interincisal mouth opening will be measured in millimeters. Changes from baseline to postoperative day 2 and postoperative day 7 will be calculated and compared between the two intervention groups.
Baseline, postoperative day 2, and postoperative day 7
Total analgesic consumption during the first postoperative week
Tidsramme: Postoperative days 0 to 7
Analgesic consumption will be recorded as the total number of analgesic tablets used by each participant during the first postoperative week.
Postoperative days 0 to 7
Operation duration
Tidsramme: During the intervention procedure
Operation duration will be recorded in minutes for each participant and compared between the two intervention groups.
During the intervention procedure
State anxiety score
Tidsramme: Baseline, postoperative day 2, and postoperative day 7
State anxiety will be assessed using the State-Trait Anxiety Inventory-State form. Total scores will be recorded preoperatively and on postoperative days 2 and 7, and compared between the two intervention groups.
Baseline, postoperative day 2, and postoperative day 7
Clinical wound healing score
Tidsramme: Postoperative days 2, 7, 14, and 21
Clinical wound healing will be assessed using the Landry, Turnbull and Howley Wound Healing Index. Wound healing scores will be recorded on postoperative days 2, 7, 14, and 21 and compared between the two intervention groups.
Postoperative days 2, 7, 14, and 21
Postoperative complications and adverse events
Tidsramme: From the intervention procedure through postoperative day 21
The occurrence of postoperative complications or adverse events, including unexpected pain, bleeding, infection, wound healing problems, or other procedure-related adverse events, will be recorded during the follow-up period.
From the intervention procedure through postoperative day 21

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kutahya Health Sciences University

Etterforskere

  • Hovedetterforsker: Muhammet Yasin Pektaş, Asst. Prof, DDS, Kutahya Health Sciences University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. juli 2026

Primær fullføring (Antatt)

2. mai 2027

Studiet fullført (Antatt)

21. mai 2027

Datoer for studieregistrering

Først innsendt

13. juli 2026

Først innsendt som oppfylte QC-kriteriene

13. juli 2026

Først lagt ut (Faktiske)

16. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MLF-DL-KRYO-2026-01

Plan for individuelle deltakerdata (IPD)

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NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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