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Completed

NCT Number: NCT07465536

Comparison of Diode Laser and Scalpel Frenectomy With or Without Photobiomodulation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University Faculty of Dentistry

Köseköy, Kocaeli, 41190, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scalpel Frenectomy

Procedure

Conventional frenectomy performed using a surgical scalpel for the treatment of aberrant maxillary labial frenulum.

Diode Laser Frenectomy

Procedure

Frenectomy performed using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum.

photobiomodulation therapy

Device

Low-level laser therapy applied postoperatively to enhance wound healing and reduce postoperative pain and discomfort.

Primary outcomes

  1. Postoperative Pain

    Time frame: Day 1 and Day 7 after surgery

    Postoperative pain intensity assessed using a Visual Analog Scale (VAS) following frenectomy procedures.

  2. Speech Difficulty

    Time frame: Day 1 and Day 7 after surgery

    Speech difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures.

  3. Chewing Difficulty

    Time frame: Day 1 and Day 7 after surgery

    Chewing difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures.

  4. Total Analgesic Consumption

    Time frame: Within 7 days after surgery

    Total number of analgesic tablets consumed during the postoperative period.

Secondary outcomes

  1. Plaque Index (PI)

    Time frame: Baseline and 2 months after surgery

    Plaque accumulation assessed using the Silness and Löe Plaque Index at the maxillary central incisors.

  2. Gingival Index (GI)

    Time frame: Baseline and 2 months after surgery

    Gingival inflammation assessed using the Löe and Silness Gingival Index at the maxillary central incisors.

  3. Probing Depth (PD)

    Time frame: 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.

  4. Keratinized Tissue Width (KTW)

    Time frame: Baseline and 2 months after surgery

    Width of keratinized gingiva measured clinically using Lugol's iodine staining and a calibrated periodontal probe.

  5. OHIP-14

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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