跳至主要内容
临床试验/NCT04694222
NCT04694222已完成不适用

Evaluation of Efficacy of LANAP and Adjunctive LLLT Application in the Treatment of Periodontitis: A Randomized Controlled Clinical Study

Izmir Katip Celebi University2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2017年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
试验地点
2
主要终点
Clinical attachment level gain

研究概览

简要总结

In this study, it is evaluated the effects of laser assisted new attachment procedure (LANAP) and low level laser therapy (LLLT) and on clinical, biochemical and radiographic parameters in addition to non-surgical periodontal treatment (NSPT).

详细描述

The study was designed as a randomized-controlled, single-blind and parallel design consisting of 80 patients with chronic periodontitis. Study consists of 4 groups, with 20 patients in each group. Group 1 received only NSPT, Group 2 received NSPT+LANAP, Group 3 received NSPT+LLLT, and Group 4 received NSPT+LANAP+LLLT. Clinical measurements of patients and gingival crevicular fluid (GCF) were taken before treatment and after 1 and 3 months. In GCF, interleukin-1beta, interleukin-10 and vascular endothelial growth factor were analyzed. Standard periapical radiographs were taken for radiographic measurements.

In moderate (4-6 mm) and deep pockets (7 mm and above), it was found that all groups treated with laser significantly decrease pocket depth (PD) and clinic attachment level (CAL) compared to Group 1. Group 3 caused significantly less gingival recession than all other groups. There was no statistical difference between the groups in biochemical markers. Radiographic analysis revealed that only Group 2 achieved significant bone filling compared to Group 1.

Bot LANAP and LLLT application in the deep pockets provide an additional contribution to NSPT. It has been found that LLLT administration leads to decrease in PD by creating a minimum recession.

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
Single (Outcomes Assessor)

盲法说明

Clinical measurements were performed by a masked calibrated researcher to provide blindness

入排标准

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

入选标准

  • periodontitis of periodontal stage II, III, or IV with grades B
  • with at least 12 teeth in the mouth and had ≥4 teeth but not all of them in the same quadrant
  • with Probing depth of ≥5 mm, Clinical attachment level of ≥4 mm
  • radiographic evidence of alveolar bone loss

排除标准

  • pregnancy and lactation
  • using antibiotics in the last 6 months and anti-inflammatory drugs in the last 3rd months,
  • having the systemic disease and the use of the drug that will affect the periodontal condition, having restoration of the adjacent tooth to be collected gingival crevicular fluid

结局指标

主要结局

Clinical attachment level gain

时间窗: 3 month

The clinical attachment level is determined by measuring the distance from the cemento-enamel junction to the gingival margin and adding the pocket depth to it.

次要结局

  • Radiographic bone fill(3 Month)
  • Plaque index(3 Month)
  • Interleukin-1beta(3 Month)
  • Gingival index(3 Month)
  • Probing depth(3 Month)
  • vascular endothelial growth factor (VEGF)(3 Month)
  • Bleeding on probing(3 Month)
  • Interleukin-10(3 Month)

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fadime KAYA DADAS

principal investigator

Izmir Katip Celebi University

研究点 (2)

Loading locations...

相似试验