跳至主要内容
临床试验/NCT02737176
NCT02737176Unknown不适用

Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial

Association for the Japanese Academy of Maxillofacial Implants4 个研究点 分布在 1 个国家目标入组 812 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
812
试验地点
4
主要终点
Pocket depth in peridontitis

研究概览

简要总结

This study is to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial. Tobacco cessation intervention is implemented for 12 weeks. During the tobacco cessation intervention for the subjects, attending doctors implement standard treatments for their oral diseases. Improvement of each disease is evaluated between smoking cessation intervention group and non-cessation intervention group.

详细描述

It has been concluded that available evidence suggests that behavioral interventions for tobacco cessation conducted by oral health professionals incorporating an oral examination component in the dental office or community setting may increase tobacco abstinence rates among both cigarette smokers and smokeless tobacco users (Cochrane Database Syst Rev.6:CD005084.) However, efficacy of tobacco cessation for oral diseases by oral health professionals are not elucidated. There are few studies on tobacco cessation intervention by dentists but none in terms of reduction of oral diseases or further disease prevention. Association for the Japanese Academy of Maxillofacial Implants, Association for the Japanese Society of Oral and Maxillofacial Surgeons, Association for the Japanese Society of Oral Implantology, Japanese Society of Oral Medicine, Japanese Society of Periodontology, Japanese Academy of Clinical Periodontology, Japanese Society for Oral Health, Japanese Society of Dentistry for Medically Compromised Patient and Japanese Society of Oral Oncology conduct a study to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Inclusion Criteria:
  • Current smokers with periodontitis; 30% or more of the teeth where periodontal pocket depth (PPD) is 4mm or more and 3 or more sites in 6mm or more of the PPD
  • Current smokers in patients about to receive implant placement
  • Current smokers with oral mucosal diseases clinically diagnosed for nicotine stomatitis, oral leukoplakia, erythroplakia and oral lichen planus

排除标准

  • Already having any cessation intervention
  • Periodontitis with having anti-inflammatory drug or steroid use and have had periodontal treatment within 6 months
  • Oral mucosal diseases having had surgical resections or other interventional treatments

结局指标

主要结局

Pocket depth in peridontitis

时间窗: Change from baseline at 12 months

Pocket depth and attachment loss with or without surgical treatment

Per-implant marginal bone loss

时间窗: Change from baseline at 12 months

Per-implant marginal bone loss by a standardized X-ray photo

Size reduction of oral mucosal diseases

时间窗: Change from baseline at 12 months

Size reduction (major x minor axis /mm) at a predominant site for non-surgical group

次要结局

  • Tobacco abstinence rate(3,6,12 and 24 months)
  • HPV-DNA detection (p16 & 18)(pre- and post-treatment (12 months))

研究者

发起方
Association for the Japanese Academy of Maxillofacial Implants
申办方类型
Other
责任方
Principal Investigator
主要研究者

Toru Nagao, PhD, DMSc, DDS

Director

Association for the Japanese Academy of Maxillofacial Implants

研究点 (4)

Loading locations...

相似试验