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临床试验/NCT07034625
NCT07034625已完成不适用

Comparative Evaluation of Hyaluronic Acid Spray and Low-Level Laser Therapy on Wound Healing Following Gingivectomy

Akdeniz University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年6月1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
64
试验地点
1
主要终点
Wound Healing Percentage

研究概览

简要总结

Gingival enlargement may impair oral hygiene, esthetics, and periodontal health, and gingivectomy is commonly performed when non-surgical treatment is insufficient. Because gingivectomy wounds heal by secondary intention, postoperative wound healing and pain control are clinically important. Low-level laser therapy and hyaluronic acid are adjunctive approaches that may support tissue healing through different biological mechanisms.

This randomized controlled clinical trial compared the effects of topical 0.04% high-molecular-weight hyaluronic acid spray and low-level laser therapy on early wound healing and postoperative pain following gingivectomy. Sixty-four systemically healthy patients requiring gingivectomy were randomly assigned to receive either hyaluronic acid spray applied twice daily for 7 days or 940-nm diode laser therapy applied on postoperative days 0, 3, 5, and 7. Wound healing was assessed using standardized clinical photographs and digital planimetric analysis at baseline and on postoperative days 3, 7, and 14. Postoperative pain was evaluated using a visual analogue scale, and periodontal parameters were recorded at baseline and 6 weeks.

The study aimed to compare these two adjunctive postoperative wound-management approaches after gingivectomy.

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
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Systemically healthy
  • •Having chronic inflammatory gingival hyperplasia affecting at least 6 teeth symmetrically in the maxillary or mandibular anterior region with gingivectomy indication
  • •No usage of any medication affecting periodontal tissues or causing gingival hyperplasia such as antiepileptics, immunosupresors or calcium channel blockers
  • •No history of periodontitis with attachment and bone loss

排除标准

  • •Having systemic disease
  • •Pregnancy or breastfeeding
  • •Inadequate oral hygiene
  • •Antibiotic usage for the past six months

研究组 & 干预措施

Hyaluronic Acid Spray

Active Comparator

Participants in this group received topical 0.04% high-molecular-weight hyaluronic acid spray after gingivectomy. Patients were instructed to apply the spray to the surgical wound area twice daily for the first 7 postoperative days.

干预措施: Hyaluronic Acid Spray (Other)

Low Level Laser Therapy

Active Comparator

Participants in this group received low-level laser therapy after gingivectomy. A 940-nm diode laser was applied to the surgical wound area on postoperative days 0, 3, 5, and 7. The laser parameters were 3 W power output, 1.07 W/cm² power density, 2.8 cm² probe spot size, continuous wave mode, 1-mm application distance, and non-contact stationary application for 120 seconds per session.

干预措施: Low Level Laser Therapy (Other)

结局指标

主要结局

Wound Healing Percentage

时间窗: Baseline, postoperative day 3, day 7, and day 14

Wound healing was assessed by measuring the surgical wound surface area using standardized clinical photographs and digital planimetric analysis with ImageJ software. At baseline and on postoperative days 3, 7, and 14, the gingivectomy wound area was stained with an erythrosin-based plaque-disclosing agent to identify non-epithelialized or insufficiently keratinized areas. The healing percentage was calculated by comparing the wound area at each postoperative time point with the baseline wound area using the following formula: Healing (%) = \[(Baseline wound area - Wound area at time point) / Baseline wound area\] × 100.

次要结局

  • Postoperative Pain Score (VAS)(Postoperative day 1, day 3, day 7, and day 14)
  • Gingival Index(Baseline and 6 weeks postoperatively)
  • Full Mouth Bleeding Score(Baseline and 6 weeks postoperatively)
  • Probing Pocket Depth(Baseline and 6 weeks postoperatively)

研究者

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

İpek Özgü

Dr.

Akdeniz University

研究点 (1)

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