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

NCT07708389 | Not Yet Recruiting

• 1 other identifier: MLF-DL-KRYO-2026-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maxillary Labial Frenulum Abnormality; Hypertrophic Maxillary Labial Frenulum

Keywords

Maxillary labial frenectomy; Diode laser; 970-nm diode laser; Liquid nitrogen cryotherapy; Salivary cortisol; Postoperative pain; Wound healing

Outcome Measures

Primary Outcomes (1)

• Change in salivary cortisol level from baseline to 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

Secondary Outcomes (9)

• Change in salivary cortisol level from baseline to postoperative day 7

  Baseline and postoperative day 7

• Change in postoperative edema

  Baseline, postoperative day 2, and postoperative day 7

• Postoperative pain intensity

  Postoperative 6 hours, 12 hours, 24 hours, day 2, and day 7

• Change in interincisal mouth opening

  Baseline, postoperative day 2, and postoperative day 7

• Total analgesic consumption during the first postoperative week

  Postoperative days 0 to 7

Study Arms (2)

970-nm Diode Laser Frenectomy

EXPERIMENTAL

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.

Procedure: 970-nm Diode Laser Frenectomy

Liquid Nitrogen Cryotherapy

EXPERIMENTAL

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.

Procedure: Liquid Nitrogen Cryotherapy

Interventions

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.

Also known as: Diode laser frenectomy

970-nm 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.

Liquid Nitrogen Cryotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University Faculty of Dentistry

Kütahya, Kütahya, 43020, Turkey (Türkiye)

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Muhammet Yasin Pektaş, Asst. Prof, DDS

  Kutahya Health Sciences University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammet Yasin Pektaş, Asst. Prof, DDS

CONTACT

+905541351195; muhammetyasin.pektas@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative clinical outcome assessments, including wound healing scoring, will be performed by an outcomes assessor who is blinded to the allocated intervention group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into two parallel intervention groups: 970-nm diode laser frenectomy and liquid nitrogen cryotherapy.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): May 21, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)