跳至主要内容
临床试验/NCT05655338
NCT05655338已完成不适用

Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis): A Comparison Between Photodynamic Therapy and Antibiotic Therapy as an Adjunct to Non-Surgical Periodontal Treatment

University of Ljubljana0 个研究点目标入组 20 人开始时间: 2015年1月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20
主要终点
Bleeding on probing

研究概览

简要总结

Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.

详细描述

Background: Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Materials and methods: Twenty subjects with untreated aggressive periodontitis (stage III, grade C periodontitis) were divided into two groups: the test group (TG) received non-surgical therapy and two sessions of aPDT using a laser (HELBO TheraLite laser) with a wavelength of 670nm associated with HELBO Blue photosensitizer, and the control group (CG) received non-surgical therapy and antibiotics (amoxicillin 500mg and metronidazole 400mg, 7 days). Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.

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 (Care Provider)

盲法说明

The blindness of the examiner was ensured by restriction of access to the patients' data. Only the supervisor (MP) had access to the allocation data and therefore knew which patients received additional aPDT treatment.

Periodontal examinations of 5 randomly selected individuals were carried out twice by the same examiner, and the second measurements were repeated after two weeks. The reproducibility of assessing all periodontal parameters was tested. Intra-examiner calibration scores were 0.95.

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aggressive periodontitis (stage III, grade C periodontitis)
  • nonsmokers
  • at least 20 teeth in oral cavity
  • systemically healthy

排除标准

  • any previous periodontal treatment
  • pregnancy
  • ingestion of systemic antibiotics within three months before therapy

研究组 & 干预措施

ANTIMICROBIAL PHOTODYNAMIC THERAPY

Experimental

The patients received antimicrobial photodynamic therapy after non-surgical periodontal treatment

干预措施: antimicrobial photodynamic therapy (Device)

SYSTEMIC ANTIBIOTICS

Experimental

The patients received systemic antibiotics after non-surgical periodontal treatment

干预措施: systemic antibiotics (Drug)

结局指标

主要结局

Bleeding on probing

时间窗: 3 months

Bleeding after measurement of probing depth

Probing depth reduction

时间窗: 3 months

Change in probing depth

次要结局

  • Clinical attachment loss(3 months)

研究者

申办方类型
Other
责任方
Sponsor

相似试验