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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

More Kutahya Health Sciences University trials in Turkey