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

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.

Study Overview

• Status: Completed
• Conditions: Frenulum; Hypertrophy, Lip
• Intervention / Treatment: Procedure: Scalpel Frenectomy; Device: Photobiomodulation Therapy; Procedure: Diode Laser Frenectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kocaeli
    • Köseköy, Kocaeli, Turkey (Türkiye), 41190
      • Kocaeli University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scalpel Frenectomy; Participants underwent conventional scalpel frenectomy for the treatment of aberrant maxillary labial frenulum.	Procedure: Scalpel Frenectomy; Conventional frenectomy performed using a surgical scalpel for the treatment of aberrant maxillary labial frenulum.
Experimental: Scalpel Frenectomy + Photobiomodulation Therapy; Participants underwent conventional scalpel frenectomy followed by adjunctive photobiomodulation therapy to enhance postoperative healing and reduce discomfort.	Procedure: Scalpel Frenectomy; Conventional frenectomy performed using a surgical scalpel 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.
Experimental: Diode Laser Frenectomy; Participants underwent frenectomy using an 810-nm diode laser 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.
Experimental: Diode Laser Frenectomy + Photobiomodulation Therapy; Participants underwent frenectomy using an 810-nm diode laser followed by adjunctive photobiomodulation therapy to enhance postoperative healing and reduce discomfort.	Device: Photobiomodulation Therapy; Low-level laser therapy applied postoperatively to enhance wound healing and reduce postoperative pain and discomfort.; Procedure: Diode Laser Frenectomy; Frenectomy performed using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Postoperative pain intensity assessed using a Visual Analog Scale (VAS) following frenectomy procedures.	Day 1 and Day 7 after surgery
Speech Difficulty	Speech difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures.	Day 1 and Day 7 after surgery
Chewing Difficulty	Chewing difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures.	Day 1 and Day 7 after surgery
Total Analgesic Consumption	Total number of analgesic tablets consumed during the postoperative period.	Within 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index (PI)	Plaque accumulation assessed using the Silness and Löe Plaque Index at the maxillary central incisors.	Baseline and 2 months after surgery
Gingival Index (GI)	Gingival inflammation assessed using the Löe and Silness Gingival Index at the maxillary central incisors.	Baseline and 2 months after surgery
Probing Depth (PD)	Periodontal probing depth measured at the mesial, distal, buccal and palatal aspects of the maxillary central incisors using a calibrated periodontal probe.	Baseline and 2 months after surgery
Keratinized Tissue Width (KTW)	Width of keratinized gingiva measured clinically using Lugol's iodine staining and a calibrated periodontal probe.	Baseline and 2 months after surgery
OHIP-14	Oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.	Baseline, Day 1 and Day 7 after surgery

Collaborators and Investigators

• Sponsor: Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2015
• Primary Completion (Actual): March 16, 2016
• Study Completion (Actual): May 6, 2016

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hypertrophy; Lymphoid Interstitial Pneumonia; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: 2015/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No