Diode Laser Versus Conventional Frenectomy in Children

Condition(s) studied

Investigational drug(s) / intervention(s)

Diode Laser Frenectomy: Maxillary labial frenectomy will be performed using a Woodpecker LX16 Plus diode laser under standardized clinical conditions. The procedure will be carried out by the Department of Periodontology. Laser parameters, including wavelength, power, operating mode, fiber diameter, and application technique, will be standardized according to the final study protocol.

Conventional Scalpel Frenectomy: Maxillary labial frenectomy will be performed using a conventional surgical scalpel under standardized clinical conditions. The procedure will be carried out by the Department of Periodontology according to the study protocol.

Study summary

This prospective, randomized, open-label, parallel-group clinical trial aims to compare diode laser frenectomy with conventional scalpel frenectomy in children aged 8-12 years with a clinical indication for maxillary labial frenectomy. Participants will be randomly allocated in a 1:1 ratio to undergo either diode laser or conventional scalpel frenectomy. Postoperative pain, wound healing, analgesic requirement, feeding difficulty, and daily comfort will be evaluated during follow-up. Gingival crevicular fluid samples will be collected at baseline and on postoperative Days 3, 7, and 14 to assess local molecular changes associated with inflammation, tissue injury, wound healing, and periodontal-alveolar remodeling using RT-qPCR.

Eligibility

Primary outcome measure(s)

• Relative IL1B Gene Expression in Gingival Crevicular Fluid — Baseline (Day 0) and postoperative Days 3, 7, and 14
  Relative IL1B gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
• Relative TNF Gene Expression in Gingival Crevicular Fluid — Baseline (Day 0) and postoperative Days 3, 7, and 14
  Relative TNF gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
• Relative IL8 Gene Expression in Gingival Crevicular Fluid — Baseline (Day 0) and postoperative Days 3, 7, and 14
  Relative IL8 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
• Relative FGF2 Gene Expression in Gingival Crevicular Fluid — Baseline (Day 0) and postoperative Days 3, 7, and 14
  Relative FGF2 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
• Relative TGFB1 Gene Expression in Gingival Crevicular Fluid — Baseline (Day 0) and postoperative Days 3, 7, and 14
  Relative TGFB1 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
• Relative LDHA Gene Expression in Gingival Crevicular Fluid — Baseline (Day 0) and postoperative Days 3, 7, and 14
  Relative LDHA gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.
• Postoperative Wound Healing Assessed Using the Landry, Turnbull and Howley Wound Healing Index — Postoperative Days 3, 7, and 14
  Postoperative wound healing will be evaluated using the Landry, Turnbull and Howley Wound Healing Index. Healing will be scored from 1 (very poor healing) to 5 (excellent healing). Scores will be compared between treatment groups and across postoperative follow-up time points.
• Postoperative Pain Intensity Assessed Using the Visual Analog Scale — Postoperative Days 3, 7, and 14
  Postoperative pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be compared between treatment groups and across postoperative follow-up time points.

Trial sites (1)

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