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临床试验/NCT06383455
NCT06383455已完成不适用

Effects of Smoking on Clinical and Microbiological Response Following Non-Surgical Periodontal Treatment in Periodontitis Patients

Trakya University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年9月15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
48
试验地点
1
主要终点
Change in levels of periodontopathogens in subgingival plaque after non-surgical periodontal therapy in smokers and non-smokers with stage 3/4 periodontitis

研究概览

简要总结

This study aimed to compare the distribution of subgingival periodontal pathogens following non-surgical periodontal therapy in smoking and non-smoking people with periodontitis. The main question it aims to answer is:

  • Does smoking affect the results of non-surgical periodontal treatment on subgingival flora in participants with periodontal disease?

Researchers performed non-surgical periodontal therapy on 48 participants with stage III/IV periodontitis and recorded clinical measurements. They obtained subgingival plaque samples from periodontal pockets at the onset and after four weeks of treatment, determining the level of periodontopathogens using a polymerase chain reaction-based method.

详细描述

The present study aims to compare the changes in clinical parameters and subgingival periodontopathogen rates (P. gingivalis, A. actinomycetemcomitans, T. forsythia, F. nucleatum, P. intermedia, T. denticola, P. micra, C. rectus, E. nodatum, Capnocytophaga spp, and E. corrodens) following full-mouth scaling and root planing procedures in participants with and without smoking habits.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Having 15 or more permanent teeth (except third molars and teeth with endodontic lesions),
  • Having been diagnosed with generalized Stage III or IV periodontitis that progresses with periodontal support tissue loss in more than 30% of the teeth,
  • Having at least five teeth with probing depth(PD) ≥6mm, clinical attachment level(CAL) ≥5mm, and radiographic bone loss that extends to at least the middle of the root,
  • Having at least one tooth that meets the same PD and CAL criteria per quadrant.

排除标准

  • Pregnancy or lactation,
  • Any systemic disease with a potential influence on the immune response (diabetes mellitus, bone metabolic diseases, immunosuppressive therapy, radiation etc.),
  • Existence of decay, restoration, or prosthesis on the sampling site,
  • Use of the anti-inflammatory drug and antibiotic within the last 3 months.

结局指标

主要结局

Change in levels of periodontopathogens in subgingival plaque after non-surgical periodontal therapy in smokers and non-smokers with stage 3/4 periodontitis

时间窗: Baseline and four weeks after the periodontal therapy.

The baseline levels of periodontopathogens (P. gingivalis, A. actinomycetemcomitans, T. forsythia, F. nucleatum, P. intermedia, T. denticola, P. micra, C. rectus, E. nodatum, Capnocytophaga spp, and E. corrodens), post-treatment levels, and elimination levels with treatment were evaluated using multiplex polymerase chain reaction (PCR) analysis.The observed rates of microorganisms were assessed by determining six main levels. 0: No colouring (\<1% no bacteria) 1. Very light-colored staining (Determination of bacteria from 1% to 20%). 2. Light colored staining (Determination of bacteria from 21% to 40%), 3. Moderate colored staining (Determination of bacteria from 41% to 60%), 4. Dark colored staining (Determination of bacteria from 61% to 80%), 5. Very dark-colored staining (Determination of bacteria from 81% to 100%).

次要结局

  • Change in probing depth (PD)(Baseline and 4 weeks after periodontal therapy)
  • Change in Bleeding on Probing (BOP)(Baseline and 4 weeks after periodontal therapy)
  • Change in clinical attachment level (CAL)(Baseline and 4 weeks after periodontal therapy)
  • Change in plaque index (PI) scores(Baseline and 4 weeks after periodontal therapy)
  • Change in gingival index (GI) scores(Baseline and 4 weeks after periodontal therapy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ece AÇIKGÖZ ALPARSLAN

Assisstant Professor

Trakya University

研究点 (1)

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