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临床试验/NCT07462117
NCT07462117已完成不适用

Comparative Analysis of the Performance of Three Dental Lasers Versusthe Conventional Scalpeltechnique in Vestibuloplasty

University of Medicine and Pharmacy "Victor Babes" Timisoara1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年4月30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
发起方
入组人数
36
试验地点
1
主要终点
pain and comfort

研究概览

简要总结

The aim of this study was to compare the clinical results obtained using the conventional approach versus the modern laser method, by recording postoperative results

详细描述

The patients were divided in 3 equal groups and the vestibuloplasty was performed by conventional surgery on the right side and by laser for the left side of the maxilla. The former served as a Control group. There were utilized three types of lasers and consequently divided the patients in three observational study groups: for Group 1, the vestibuloplasty was performed by Nd-YAG laser, for Group 2 a diode laser was utilized , while Group 3 was treated with an Er-YAG laser.

An initial measurement of the vestibular depth was performed by using a millimeter markings William periodontal probe on three predetermined areas on each side: paramedian (next to the frenulum), antero-lateral (measured in the middle of the operated field), and lateral (at the most posterior place included in surgery). The measurements were performed 6 weeks postoperatively at the same levels as they were registered before surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
62 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Systemically healthy 36 edentulous patients , We selected the patients to be candidates for total prostheses and complete edentulous at the level of the maxilla.

排除标准

  • no comorbidities

研究组 & 干预措施

Nd -YAG vestibuloplasty group

Active Comparator

12 patients treated for Group 1 using a Nd-YAG laser on the left side of the maxilla. The procedure was performed under local anesthesia to ensure patient comfort and cooperation. The parameters for the Nd-YAG laser (Lightwalke, Fotona, Slovenia) that was utilized for this procedure were: center wavelength of 1064 nm, output power of 4 W, frequency equal to 25 Hz, Micro Short Pulse (MSP) mode, sapphire fiber of 300 micrometers in diameter, power density equal to 6229 W/cm2.

The right side was treated conventional using the scalpel. Clark's vestibuloplasty method was applied in all conventionally operated right sides of the patients

干预措施: vestibuloplasty for Nd-YAG group (Procedure)

Diode laser vestibuloplasty group

Active Comparator

12 patients treated for Group 2 where a diode laser was utilized. for performing the left side of the maxilla. we utilized the Epic X TM laser from Biolase, with a center wavelength of 940 nm and a pre-initiated tip, in a contact, continuous mode, with an output energy of 3 W. Surgery with the laser tip began at the mucogingival junction with a horizontal movement directing the laser parallel to the bone, and thus slowly releasing the muscle fibers towards the new vestibule depth. The right side of the maxilla was performed by conventional surgery using Clark s method.

干预措施: diode vestibuloplasty (Procedure)

Er-YAG laservestibuloplasty group

Active Comparator

12 patients treated for Group 3 where an Er-YAG laser was utilized to treat the left side of the maxilla. The Er-YAG laser (Lightwalker, Fotona, Slovenia) was equipped with a H14 handpiece, characterized by the following parameters: center wavelength of 2940 nm, contact mode, long pulse, energy of 200 mJ, frequency equal to 20 Hz, power of 4 W, water 2, gas 2. The right side of the maxilla was performed by conventional surgery using Clark s method

干预措施: Er-YAG laser vestibuloplasty (Procedure)

结局指标

主要结局

pain and comfort

时间窗: days 1, 3, and 7 postoperatively

Pain and discomfort values were compared between the conventional surgery and the Nd:YAG laser, diode laser, and Er-YAG laser groups by using the Wilcoxon signed-rank test. The laser-treated sides have shown statistically significant reductions in both pain and discomfort scores at all considered timepoints (p \< 0.05), as presented in the following.

The vestibular gain depth

时间窗: 6 weeks

Vestibular depth measurements were compared between the initial, the immediate postoperatively, and the 6-week postoperatively timepoints. Paired sample t-tests or Wilcoxon tests were utilized, depending on distribution, to evaluate changes within each technique (i.e., conventional and lasers).

次要结局

未报告次要终点

研究者

发起方
University of Medicine and Pharmacy "Victor Babes" Timisoara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nica Diana Florina

doctor

University of Medicine and Pharmacy "Victor Babes" Timisoara

研究点 (1)

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