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Not yet recruiting NCT07708389

970-nm Diode Laser Versus Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy

No phase Interventional Maxillary Labial Frenulum Abnormality Hypertrophic Maxillary Labial Frenulum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 970-nm Diode Laser Frenectomy, Liquid Nitrogen Cryotherapy.
Who it may be relevant to
Registry conditions: Maxillary Labial Frenulum Abnormality, Hypertrophic Maxillary Labial Frenulum. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure 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.
  • Procedure 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.

Primary outcome measures

  • Change in salivary cortisol level from baseline to postoperative day 2 [Time frame: Baseline and postoperative day 2]
Secondary outcome measures (9)
  • Change in salivary cortisol level from baseline to postoperative day 7 [Time frame: Baseline and postoperative day 7]
  • Change in postoperative edema [Time frame: Baseline, postoperative day 2, and postoperative day 7]
  • Postoperative pain intensity [Time frame: Postoperative 6 hours, 12 hours, 24 hours, day 2, and day 7]
  • Change in interincisal mouth opening [Time frame: Baseline, postoperative day 2, and postoperative day 7]
  • Total analgesic consumption during the first postoperative week [Time frame: Postoperative days 0 to 7]
  • Operation duration [Time frame: During the intervention procedure]
  • State anxiety score [Time frame: Baseline, postoperative day 2, and postoperative day 7]
  • Clinical wound healing score [Time frame: Postoperative days 2, 7, 14, and 21]
  • Postoperative complications and adverse events [Time frame: From the intervention procedure through postoperative day 21]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Kutahya Health Sciences University Faculty of Dentistry — Kütahya

Publications

  • Opaleye T, Okoturo E, Adesina OA, Oyapero A, Salami Y, Wemambu JC. Salivary Cortisol as a Stress Monitor During Third Molar Surgery. J Maxillofac Oral Surg. 2022 Dec;21(4):1112-1118. doi: 10.1007/s12663-020-01480-2. Epub 2020 Nov 22. PMID 36896050
  • Georgakopoulou E, Loumou P, Sgouros D, Chaurasia A, Panagiotopoulos A. Cryosurgery in oral lesions. J Clin Exp Dent. 2025 Oct 1;17(10):e1257-e1266. doi: 10.4317/jced.63133. eCollection 2025 Oct. PMID 41255399
  • Sobouti F, Moallem Savasari A, Aryana M, Hakimiha N, Dadgar S. Maxillary labial frenectomy: a randomized, controlled comparative study of two blue (445 nm) and infrared (980 nm) diode lasers versus surgical scalpel. BMC Oral Health. 2024 Jul 25;24(1):843. doi: 10.1186/s12903-024-04364-w. PMID 39054510

Identifiers

NCT: NCT07708389 · MLF-DL-KRYO-2026-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗