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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scalpel Frenectomy | Experimental | Participants underwent conventional scalpel frenectomy for the treatment of aberrant maxillary labial frenulum. |
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| Scalpel Frenectomy + Photobiomodulation Therapy | Experimental | Participants underwent conventional scalpel frenectomy followed by adjunctive photobiomodulation therapy to enhance postoperative healing and reduce discomfort. |
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| Diode Laser Frenectomy | Experimental | Participants underwent frenectomy using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum. |
|
| Diode Laser Frenectomy + Photobiomodulation Therapy | Experimental | Participants underwent frenectomy using an 810-nm diode laser followed by adjunctive photobiomodulation therapy to enhance postoperative healing and reduce discomfort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scalpel Frenectomy | Procedure | Conventional frenectomy performed using a surgical scalpel for the treatment of aberrant maxillary labial frenulum. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli University Faculty of Dentistry | Köseköy | Kocaeli | 41190 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| C562489 | Lymphoid Interstitial Pneumonia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| 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. |
|
| 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 |