Hypertrophic Maxillary Labial Frenulum, Maxillary Labial Frenulum Abnormality
Conditions
Keywords
Maxillary labial frenectomy, Diode laser, 970-nm diode laser, Liquid nitrogen cryotherapy, Salivary cortisol, Postoperative pain, Wound healing
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.
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
PROCEDURE970-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.
PROCEDURELiquid 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.
Sponsors
Kutahya Health Sciences University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Postoperative clinical outcome assessments, including wound healing scoring, will be performed by an outcomes assessor who is blinded to the allocated intervention group.
Intervention model description
Participants will be randomized into two parallel intervention groups: 970-nm diode laser frenectomy and liquid nitrogen cryotherapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in salivary cortisol level from baseline to postoperative day 7 | 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. |
| Change in postoperative edema | 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. |
| Postoperative pain intensity | 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. |
| Change in interincisal mouth opening | 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. |
| Total analgesic consumption during the first postoperative week | 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. |
| Operation duration | During the intervention procedure | Operation duration will be recorded in minutes for each participant and compared between the two intervention groups. |
| State anxiety score | 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. |
| Clinical wound healing score | 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. |
| Postoperative complications and adverse events | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMuhammet Yasin Pektaş, Asst. Prof, DDS
PRINCIPAL_INVESTIGATORMuhammet Yasin Pektaş, Asst. Prof, DDS
Kutahya Health Sciences University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Outcome results
None listed