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NCT Number: NCT07708389

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University Faculty of Dentistry

Kütahya, 43020, Turkey (Türkiye)

Location contact

Muhammet Yasin Pektaş, Asst. Prof., DDS

CONTACT

[email protected]

+905541351195

Muhammet Yasin Pektaş, Asst. Prof., DDS

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

970-nm Diode Laser Frenectomy

Procedure

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.

Other names: Diode laser frenectomy

Liquid Nitrogen Cryotherapy

Procedure

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 outcomes

  1. Change in salivary cortisol level from baseline to postoperative day 2

    Time frame: 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.

Secondary outcomes

  1. Change in salivary cortisol level from baseline to postoperative day 7

    Time frame: 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.

  2. Change in postoperative edema

    Time frame: 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.

  3. Postoperative pain intensity

    Time frame: 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.

  4. Change in interincisal mouth opening

    Time frame: 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.

  5. Total analgesic consumption during the first postoperative week

    Time frame: 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.

  6. Operation duration

    Time frame: During the intervention procedure

    Operation duration will be recorded in minutes for each participant and compared between the two intervention groups.

  7. State anxiety score

    Time frame: 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.

  8. Clinical wound healing score

    Time frame: 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.

  9. Postoperative complications and adverse events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammet Yasin Pektaş, Asst. Prof, DDS

CONTACT

[email protected]

+905541351195

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study 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

Acronym: MLF-DL-KRYO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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