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临床试验/NCT07465536
NCT07465536已完成不适用

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

Kocaeli University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2015年12月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
1
主要终点
Postoperative Pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Pregnancy or lactation
  • History of radiation therapy to the head and neck region
  • Previous frenectomy surgery

研究组 & 干预措施

Diode Laser Frenectomy

Experimental

Participants underwent frenectomy using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum.

干预措施: Diode Laser Frenectomy (Procedure)

Scalpel Frenectomy + Photobiomodulation Therapy

Experimental

Participants underwent conventional scalpel frenectomy followed by adjunctive photobiomodulation therapy to enhance postoperative healing and reduce discomfort.

干预措施: Photobiomodulation Therapy (Device)

Scalpel Frenectomy

Experimental

Participants underwent conventional scalpel frenectomy for the treatment of aberrant maxillary labial frenulum.

干预措施: Scalpel Frenectomy (Procedure)

Scalpel Frenectomy + Photobiomodulation Therapy

Experimental

Participants underwent conventional scalpel frenectomy followed by adjunctive photobiomodulation therapy to enhance postoperative healing and reduce discomfort.

干预措施: Scalpel Frenectomy (Procedure)

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.

干预措施: Diode Laser Frenectomy (Procedure)

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.

干预措施: Photobiomodulation Therapy (Device)

结局指标

主要结局

Postoperative Pain

时间窗: Day 1 and Day 7 after surgery

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

Speech Difficulty

时间窗: Day 1 and Day 7 after surgery

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

Chewing Difficulty

时间窗: Day 1 and Day 7 after surgery

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

Total Analgesic Consumption

时间窗: Within 7 days after surgery

Total number of analgesic tablets consumed during the postoperative period.

次要结局

  • Plaque Index (PI)(Baseline and 2 months after surgery)
  • Gingival Index (GI)(Baseline and 2 months after surgery)
  • Probing Depth (PD)(Baseline and 2 months after surgery)
  • Keratinized Tissue Width (KTW)(Baseline and 2 months after surgery)
  • OHIP-14(Baseline, Day 1 and Day 7 after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emre Yaprak

Associate Professor

Kocaeli University

研究点 (1)

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