970-nm Diode Laser Versus Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKutahya Health Sciences University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65 years.
Systemically healthy, ASA I status.
Clinical indication for maxillary labial frenectomy.
Ability to attend postoperative follow-up visits.
Disqualifiers
Systemic or local corticosteroid use within the last 6 months.
Endocrine disease that may affect cortisol levels.
Pregnancy or lactation.
Active oral infection.
Trial design
Design model
Parallel
Treatments tested in this trial
970-nm Diode Laser Frenectomy
Procedure/SurgeryMaxillary 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
Procedure/SurgeryLiquid 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: 970-nm Diode Laser FrenectomyExperimental treatment 1 intervention
Group B: Liquid Nitrogen CryotherapyExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and postoperative day 2Secondary outcomes
1
Change in salivary cortisol level from baseline to 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.
Time frame
Baseline and postoperative day 72
Change in postoperative edema
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.
Time frame
Baseline, postoperative day 2, and postoperative day 73
Postoperative pain intensity
Postoperative pain intensity will be assessed using a 0-to-10 visual analog scale, where higher scores indicate greater pain intensity.
Time frame
Postoperative 6 hours, 12 hours, 24 hours, day 2, and day 74
Change in interincisal mouth opening
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.
Time frame
Baseline, postoperative day 2, and postoperative day 7Sponsors and contacts
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Source ClinicalTrials.gov
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