Kocaeli University Faculty of Dentistry
Köseköy, Kocaeli, 41190, Turkey (Türkiye)
NCT Number: NCT07465536
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Köseköy, Kocaeli, 41190, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional frenectomy performed using a surgical scalpel for the treatment of aberrant maxillary labial frenulum.
Frenectomy performed using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum.
Low-level laser therapy applied postoperatively to enhance wound healing and reduce postoperative pain and discomfort.
Time frame: Day 1 and Day 7 after surgery
Postoperative pain intensity assessed using a Visual Analog Scale (VAS) following frenectomy procedures.
Time frame: Day 1 and Day 7 after surgery
Speech difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures.
Time frame: Day 1 and Day 7 after surgery
Chewing difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures.
Time frame: Within 7 days after surgery
Total number of analgesic tablets consumed during the postoperative period.
Time frame: Baseline and 2 months after surgery
Plaque accumulation assessed using the Silness and Löe Plaque Index at the maxillary central incisors.
Time frame: Baseline and 2 months after surgery
Gingival inflammation assessed using the Löe and Silness Gingival Index at the maxillary central incisors.
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.
Time frame: Baseline and 2 months after surgery
Width of keratinized gingiva measured clinically using Lugol's iodine staining and a calibrated periodontal probe.
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.
Kocaeli University
Other
Comparative Evaluation of Diode Laser and Scalpel Frenectomy With or Without Adjunctive Photobiomodulation: A Randomized Controlled Clinical Trial
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