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临床试验/NCT05588544
NCT05588544已完成不适用

Effect of Adjunctive YSGG Application in Healing Following Periodontal Treatment

Korea University Anam Hospital2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Change of Modified gingival index

研究概览

简要总结

Adjunctive use of Er,Cr:YSGG (erbium-chromium-yttrium-scandium-gallium-garnet) laser in combination with conventional, mechanical periodontal treatment may benefit in complete decontamination of the periodontal pocket leading to improved early healing and better long term clinical result. Radial firing periodontal tip (RFPT) offered by the Er,Cr:YSGG system is devised to let irradiation primarily in radial pattern (85%) with lesser portion in straight manner (15%), meaning laser beams are effectively emitted to affected root surface and inner epithelium of periodontal pocket with simple tip management. Therefore, using Er,Cr:YSGG laser with RFPT could be the best option for periodontal laser therapy. The aim of this study is to investigate adjunctive treatment effect using Er,Cr:YSGG laser and RFPT in moderate to severe periodontitis patients. Study subjects are randomly allocated to either 'scaling and root planing (SRP) only' or 'SRP + laser therapy' group. Periodontal parameters including probing pocket depth (PPD), clinical attachment level (CAL), modified gingival index (MGI), and plaque index (PI) are recorded at baseline and 8 weeks after treatment. Gingival crevicular fluid (GCF) samples are obtained using paper strips at baseline, 1w, 2w, 4w, and 8w post op. to determine laser-induced effect in early wound healing. Cytokine levels are evaluated from the GCF samples taken.

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

性别
All
接受健康志愿者

入选标准

  • diagnosis of stage III or IV periodontitis based on the 2017 periodontitis classification (Tonetti, Greenwell, & Kornman, 2018);
  • minimum of two teeth with probing depth (PD) ≥ 6 mm and radiographic bone loss in at least two quadrants of the whole dentition;
  • each quadrant with a minimum of four teeth; and
  • systemically healthy patients.

排除标准

  • history of periodontal treatment in the previous six months;
  • antibiotic medication in recent three months;
  • under steroid therapy or taking any anti-inflammatory drugs in recent three months;
  • history of any systemic disease that may influence the periodontal condition and treatment outcome, including diabetes mellitus, cancer, metabolic diseases, cardiovascular disease, and rheumatoid arthritis;
  • pregnancy or breastfeeding; and
  • smoking habits.

结局指标

主要结局

Change of Modified gingival index

时间窗: 1, 2, 4, and 8 week post-operatively

Level of gingival inflammation

次要结局

未报告次要终点

研究者

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

Park, Jung Soo

Clinical assistant professor

Korea University Anam Hospital

研究点 (2)

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