Frenulum; Hypertrophy, Lip
Conditions
Brief summary
This randomized controlled clinical trial aimed to compare postoperative outcames of conventional scalpel frenectomy and diode laser frenectomy with or without adjunctive photobiomodulation therapy. Postoperative pain, speech difficulty, chewing difficulty, analgesic consumption, and oral health-related quality of life (OHIP-14) were evaluated.
Detailed description
This randomized controlled clinical trial was conducted to evaluate the clinical effectiveness and patient-centered outcomes of conventional scalpel frenectomy and diode laser frenectomy with or without adjunctive photobiomodulation therapy (PBMT). Patients presenting with an aberrant maxillary labial frenulum requiring surgical intervention were recruited and randomly allocated into study groups. Frenectomy procedures were performed either using the conventional scalpel technique or an 810-nm diode laser system. In selected groups, adjunctive photobiomodulation therapy was applied following the surgical procedure. Postoperative outcomes were assessed using patient-reported outcome measures, including visual analogue scale (VAS) pain scores, speech difficulty, chewing difficulty, analgesic consumption, and oral health-related quality of life measured by the OHIP-14 questionnaire. Clinical and patient-reported outcomes were evaluated during the postoperative follow-up period to compare the effects of surgical technique and adjunctive photobiomodulation therapy on postoperative discomfort, functional recovery, and quality of life.
Interventions
PROCEDUREScalpel Frenectomy
Conventional frenectomy performed using a surgical scalpel for the treatment of aberrant maxillary labial frenulum.
PROCEDUREDiode Laser Frenectomy
Frenectomy performed using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum.
DEVICEPhotobiomodulation Therapy
Low-level laser therapy applied postoperatively to enhance wound healing and reduce postoperative pain and discomfort.
Sponsors
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Presence of clinically diagnosed aberrant maxillary labial frenal attachment requiring surgical frenectomy * Non-smoker status * Absence of systemic disease or ongoing pharmacological therapy * Absence of active oral infection * Ability to provide written informed consent
Exclusion criteria
* Pregnancy or lactation * History of radiation therapy to the head and neck region * Previous frenectomy surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | Day 1 and Day 7 after surgery | Postoperative pain intensity assessed using a Visual Analog Scale (VAS) following frenectomy procedures. |
| Speech Difficulty | Day 1 and Day 7 after surgery | Speech difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures. |
| Chewing Difficulty | Day 1 and Day 7 after surgery | Chewing difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures. |
| Total Analgesic Consumption | Within 7 days after surgery | Total number of analgesic tablets consumed during the postoperative period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index (PI) | Baseline and 2 months after surgery | Plaque accumulation assessed using the Silness and Löe Plaque Index at the maxillary central incisors. |
| Gingival Index (GI) | Baseline and 2 months after surgery | Gingival inflammation assessed using the Löe and Silness Gingival Index at the maxillary central incisors. |
| Probing Depth (PD) | Baseline and 2 months after surgery | Periodontal probing depth measured at the mesial, distal, buccal and palatal aspects of the maxillary central incisors using a calibrated periodontal probe. |
| Keratinized Tissue Width (KTW) | Baseline and 2 months after surgery | Width of keratinized gingiva measured clinically using Lugol's iodine staining and a calibrated periodontal probe. |
| OHIP-14 | Baseline, Day 1 and Day 7 after surgery | Oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. |
Countries
Turkey (Türkiye)
Outcome results
None listed