NCT07491627Enrolling By Invitation不适用
Effect of Nicotine Gingival Fibroblast Intoxication on the Response of Periodontal Treatment, in Conventional and Non Smokers: a Controlled Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- nicotine/cotinine in gum (ng/ml)
研究概览
简要总结
Impact of nicotine gingival intoxication on the clinical outcomes after periodontitis non surgical treatment
详细描述
In patients suffured of periodontitis, to evaluate the effect of nicotine gingival tissue intoxication and others smoking indicators on the severity of periodontitis and outcomes after nonsurgical periodontal treatment."
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient suffured of periodontitis, smoker and non-smoker
- •patient suffured of periodontitis
- •smoker and non-smoker
- •presence of a minimum of 6 teeth at each arch
- •minimum of 6 teeth with pocket depth of 5 mm
- •signed informed consent
排除标准
- •diabetes,
- •connective tissue disease
- •pregnancy
- •radiotherapy
- •chemotherapy
- •psychological disease
- •previous periodontal therapy
- •antibiotics intake
研究组 & 干预措施
conventionnal smoker group
Active Comparator
patient who smokes conventionnal cigarette
干预措施: periodontal non-surgical treatment (Procedure)
Non smoker group
Placebo Comparator
patient who don't smoke cigarette
干预措施: periodontal non-surgical treatment (Procedure)
结局指标
主要结局
nicotine/cotinine in gum (ng/ml)
时间窗: the day of the periodontal non surgical treatment
concentration cotinine and nicotine (ng/ml)
次要结局
- FTND score ( 0 to 9)(the day of periodontal non-surgical treatment)
- PD (mm)(baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after)
- % PD ≥ 6 mm (%)(baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after)
- PY (number/year)(the day of periodontal non-surgical treatment)
- NCC (0 to 100)(the day of periodontal non-surgical treatment)
- Furc (I,II or III)(baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after)
- periodontal ouctomes(baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after)
- BOP (%)(baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after)
- PI (%)(baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after)
研究者
Leila Salhi
PhD dental sciences
University of Liege
研究点 (1)
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