NCT07465536

Comparison of Diode Laser and Scalpel Frenectomy With or Without Photobiomodulation

Comparative Evaluation of Diode Laser and Scalpel Frenectomy With or Without Adjunctive Photobiomodulation: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Kocaeli University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Frenulum; Hypertrophy, Lip

Interventions

Type	Name	Description
PROCEDURE	Scalpel Frenectomy	Conventional frenectomy performed using a surgical scalpel for the treatment of aberrant maxillary labial frenulum.
PROCEDURE	Diode Laser Frenectomy	Frenectomy performed using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum.
DEVICE	Photobiomodulation Therapy	Low-level laser therapy applied postoperatively to enhance wound healing and reduce postoperative pain and discomfort.

Timeline

• Start date: 2015-12-02
• Primary completion: 2016-03-16
• Completion: 2016-05-06
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: Turkey (Türkiye)