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临床试验/NCT05720481
NCT05720481已完成不适用

Impact of Non Surgical Periodontal Treatment on Growth Differentiation Factor-15 Levels

University of Catania2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年9月20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
46
试验地点
2
主要终点
reduction of Growth differentiation factor-15 serum levels

研究概览

简要总结

In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Full Mouth Scaling and Root Planing (FM-SRP) treatment versus conventional oral hygiene treatment on serum CRP and Growth differentiation factor-15 levels.

详细描述

This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent.

Subjects with a diagnosis of periodontitis were enrolled in this clinical trial. The inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the furcation, 4) a minimum of six teeth per quadrant, respectively. The exclusion criteria were: 1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during the last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of the study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use of mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. Patients randomly undergo to full mouth SRP or Quadrant SRP

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
Double (Participant, Investigator)

盲法说明

Sealed envelopes

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • good condition of general health
  • a minimum of 2 teeth for each quadrant with
  • Pocket Depth (PD) ranging from 4-6 mm
  • no involvement of the furcation
  • a minimum of a six teeth per quadrant, respectively

排除标准

  • periodontal therapy during the last 12 months
  • assumption of antibiotics during the last 6 months
  • pregnancy
  • any systemic condition which might affect the effects of the study treatment
  • previous or current radiation or immunosuppressive therapies
  • use of mouthwash containing antimicrobials during the previous 3 months
  • no use of hormonal contraceptives
  • medication by anti-inflammatory and immunosuppressive drugs
  • previous history of hard drinking
  • class II and III tooth mobility

结局指标

主要结局

reduction of Growth differentiation factor-15 serum levels

时间窗: 6 months

evaluation of serum Growth differentiation factor-15 change

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

Gaetano Isola

Principal Investigator

University of Catania

研究点 (2)

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