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临床试验/NCT07064304
NCT07064304已完成不适用

Clinical Efficacy of Er,Cr:YSGG Laser for Deepithelialization of Free Gingival Grafts in Gingival Recession Treatment: A Randomized, Split-Mouth Clinical Trial

Wroclaw Medical University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2021年2月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9
试验地点
2
主要终点
Change in Recession Depth

研究概览

简要总结

Abstract: Introduction: The deepithelialized free gingival graft (DGG) technique provides high-quality connective tissue grafts (CTGs) with predictable outcomes for recession cov-erage. This study evaluates a novel method of free gingival graft (FGG) deepithelialization using an Er,Cr:YSGG laser (LDEE) for treating multiple gingival recessions. Methods: A split-mouth study was conducted on 46 (n=46) recessions in 9 patients (23 per test and control group). Sites were randomized. Full-thickness palatal grafts were harvested with a scalpel. In the test group (LDEE), deepithelialization was performed extraorally using an Er,Cr:YSGG laser (2780 nm; 2.5 W, 83.3 mJ, 30 Hz, 600 µm tip). In the control group (DEE), a 15c scalpel was used. All CTGs were applied using the modified coronally advanced tunnel (TUN) technique. Clinical parameters-recession depth (RD), keratinized tissue width (KT), gingival thickness (GT), pocket depth (PD), clinical attachment loss (CAL), pink esthetic score (PES), approximal plaque index (API), mean root coverage (MRC), and complete root coverage (CRC)-were assessed at baseline (T0), 3 months (T1), and 6 months (T2). Results: Both LDEE and DEE groups showed significant improvements in RD, KT, GT, PD, and CAL over time (p < 0.001). At T1 and T2, KT was significantly higher in the LDEE group (T1: 3.73±0.72 mm; T2: 3.98±0.76 mm) compared to the DEE group (T1: 3.21±0.61 mm; T2: 3.44±0.74 mm; p < 0.05). Other parameters (RD, GT, PD, CAL) showed no statistically significant intergroup differences at any time point (p > 0.05). After 6 months, MRC was 95% and CRC 82.6% for LDEE, compared to 94.8% and 82.6% for DEE (p > 0.05). PES scores were similar between groups at all time points (p > 0.05). Conclusion: Both laser- and scalpel-deepithelialized grafts effectively treated gingival recessions. LDEE combined with TUN resulted in significantly greater KT width compared to DEE + TUN.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 70 years
  • Presence of multiple Miller Class I or II gingival recessions
  • Good general and oral health
  • Patient consent to participate in the clinical trial
  • Availability for follow-up at 3 and 6 months

排除标准

  • Smoking or history of smoking in the last 6 months
  • Systemic diseases affecting wound healing (e.g., diabetes, immunodeficiencies)
  • Pregnancy or lactation
  • Use of medications that influence periodontal tissues (e.g., immunosuppressants, corticosteroids)
  • History of periodontal surgery in the area of interest within the past 12 months Inadequate oral hygiene (plaque index >20%)

结局指标

主要结局

Change in Recession Depth

时间窗: Baseline, 3 months, and 6 months postoperatively

Measurement of gingival recession depth in millimeters to evaluate soft tissue response to treatment. Unit of Measure: mm

Change in Pocket Depth

时间窗: Baseline, 3 months, and 6 months postoperatively

Probing depth measured from the gingival margin to the base of the periodontal pocket. Unit of Measure: mm

Change in Pink Esthetic Score

时间窗: Baseline, 3 months, and 6 months postoperatively

Percentage of interdental spaces with visible plaque, calculated to assess oral hygiene status. A lower percentage indicates better plaque control. Unit of Measure: percentage (%)

Mean Root Coverage

时间窗: 6 months postoperatively

Average percentage of root surface covered by soft tissue following treatment, calculated across all treated sites. Unit of Measure: percentage (%)

Change in Keratinized Tissue Width

时间窗: Baseline, 3 months, and 6 months postoperatively

Measurement of the width of keratinized gingiva in millimeters from the mucogingival junction to the free gingival margin. Unit of Measure: mm

Change in Gingival Thickness

时间窗: Baseline, 3 months, and 6 months postoperatively

Assessment of gingival tissue thickness using a standardized probe. Unit of Measure: mm

Change in Clinical Attachment Level

时间窗: Baseline, 3 months, and 6 months postoperatively

Measurement of the distance from the cementoenamel junction to the base of the periodontal pocket. Unit of Measure: mm

Complete Root Coverage

时间窗: 6 months postoperatively

Proportion of treated sites that achieved 100% root coverage postoperatively. Unit of Measure: percentage (%)

次要结局

  • Histopathological Evaluation of Laser-Treated Connective Tissue Grafts(Immediately postoperatively)

研究者

发起方
Wroclaw Medical University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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