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临床试验/NCT03103204
NCT03103204已完成4 期

Clinical, Microbial and Biochemistry Evaluation of Obese Individuals Submitted to One-stage Full-mouth Disinfection. A Clinical Control Parallel Study

University of Taubate2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2017年1月21日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
96
试验地点
2
主要终点
Periodontal clinical efficacy

研究概览

简要总结

Obesity and gum diseases are highly prevalent in all parts of the world. Obesity can negatively influence severity and progression rates of gum diseases. Presence of fat in the body determines a general systemic state of inflammation. On the other hand, when gum diseases are successfully treated systemic and local inflammation decrease. In addition reductions in glycemic blood levels are also observed after treatment. Periodontitis is one type of gum disease that is associated with bone loss. It could be treated within 24 hours by using a protocol, which combines dental debridement and mouthwash. This treatment protocol, named "one-stage full-mouth disinfection" works well in individuals of normal weight. However, there is no information whether it is effective in obese individuals or not. Also, it should be clarified if obesity influences response to periodontal treatment. This study hypothesized that obesity impair response to periodontal treatment. Therefore, the effects of the protocol "one-stage full-mouth disinfection" will be evaluated in obese individuals and normal weight controls. This evaluation will be based on the monitoring of several clinical, microbiological and biochemical parameters throughout 9 months. Participants will answer validated questionnaires to evaluate if treatment of gum disease would be able to improve individual's quality of life. Study population will be composed of 90 to 100 obese individuals (males or females; > 18 years of age; smokers or non smokers; > 12 natural teeth). Participants will be classified into 5 groups according to their body mass index in normal weight (n = 15 to 20); overweight (n = 15 to 20); obesity I (n = 15 to 20); obesity II (n = 15 to 20); obesity III (n = 15 to 20). Examinations will be performed before treatment and also 3, 6 and 9 months after treatment. This study will contribute to the knowledge on how obese individuals respond to this specific treatment protocol. Also, having normal weight individuals as controls the present study will contribute to a better understanding about obesity, in its different severities, influence on 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
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate to advanced generalized chronic periodontitis
  • Body mass index: > 18.5 kg/m2
  • Minimum of 12 natural teeth
  • Smokers, non-smokers or former-smokers

排除标准

  • Systemic diseases (diabetes, renal diseases, rheumatic diseases, osteoporosis and cardiovascular diseases)
  • Pregnant and lactating women
  • HIV/ AIDS
  • periodontal treatment in the last year (before baseline appointment)
  • Medication: Immunosuppressive drugs, antibiotics in the past three months (before baseline appointment) )
  • orthodontic appliance

研究组 & 干预措施

Normal weight full-mouth disinfection

Experimental
  • Normal weight (body mass index 18.5 - 24.9 kg/m2) individuals with chronic periodontitis
  • Full-mouth manual scaling and root planing within 24 hours
  • tongue cleaning with chlorhexidine gel 1% for 1 minute
  • tonsils disinfection with chlorhexidine spray 0.2%
  • rinsing with 15mL of 0.2% chlorhexidine solution for 30 seconds before and after dental scaling
  • subgingival irrigation of all periodontal pockets with 1% chlorhexidine solution
  • daily rinsing with 0.2% chlorhexidine solution (15mL/30 seconds/2 times a day

干预措施: One-stage full-mouth disinfection with chlorhexidine (Combination Product)

Overweight full-mouth disinfection

Experimental
  • Overweight (body mass index 25.0 - 29.9 kg/m2) individuals with chronic periodontitis
  • Full-mouth manual scaling and root planing within 24 hours
  • tongue cleaning with chlorhexidine gel 1% for 1 minute
  • tonsils disinfection with chlorhexidine spray 0.2%
  • rinsing with 15mL of 0.2% chlorhexidine solution for 30 seconds before and after dental scaling
  • subgingival irrigation of all periodontal pockets with with 1% chlorhexidine solution
  • daily rinsing with 0.2% chlorhexidine solution (15mL/30 seconds/2 times a day

干预措施: One-stage full-mouth disinfection with chlorhexidine (Combination Product)

Obesity I full-mouth disinfection

Experimental
  • Obesity I (body mass index 30.0 - 34.9 kg/m2) individuals with chronic periodontitis
  • Full-mouth manual scaling and root planing within 24 hours
  • tongue cleaning with chlorhexidine gel 1% for 1 minute
  • tonsils disinfection with chlorhexidine spray 0.2%
  • rinsing with 15mL of 0.2% chlorhexidine solution for 30 seconds before and after dental scaling
  • subgingival irrigation of all periodontal pockets with with 1% chlorhexidine solution
  • daily rinsing with 0.2% chlorhexidine solution (15mL/30 seconds/2 times a day

干预措施: One-stage full-mouth disinfection with chlorhexidine (Combination Product)

Obesity II full-mouth disinfection

Experimental
  • Obesity II (body mass index 35.0 - 39.9 kg/m2) individuals with chronic periodontitis
  • Full-mouth manual scaling and root planing within 24 hours
  • tongue cleaning with chlorhexidine gel 1% for 1 minute
  • tonsils disinfection with chlorhexidine spray 0.2%
  • rinsing with 15mL of 0.2% chlorhexidine solution for 30 seconds before and after dental scaling
  • subgingival irrigation of all periodontal pockets with with 1% chlorhexidine solution
  • daily rinsing with 0.2% chlorhexidine solution (15mL/30 seconds/2 times a day

干预措施: One-stage full-mouth disinfection with chlorhexidine (Combination Product)

Obesity III full-mouth disinfection

Experimental
  • Obesity III (body mass index ≥ 40.0 kg/m2) individuals with chronic periodontitis
  • Full-mouth manual scaling and root planing within 24 hours
  • tongue cleaning with chlorhexidine gel 1% for 1 minute
  • tonsils disinfection with chlorhexidine spray 0.2%
  • rinsing with 15mL of 0.2% chlorhexidine solution for 30 seconds before and after dental scaling
  • subgingival irrigation of all periodontal pockets with with 1% chlorhexidine solution
  • daily rinsing with 0.2% chlorhexidine solution (15mL/30 seconds/2 times a day

干预措施: One-stage full-mouth disinfection with chlorhexidine (Combination Product)

结局指标

主要结局

Periodontal clinical efficacy

时间窗: Changes in clinical attachment measurements from baseline to 6 months

Improvements in clinical attachment level (mm) overtime and comparisons among groups at 6 months after treatment

次要结局

  • Oral safety and tolerability(Changes in salivary nitrite levels from baseline to 6 months)
  • Impact on quality of life(Changes in scores (Likert scale ranging from 0 to 56 points) of Oral impacts on daily performance questionnaire from baseline to 6 months)
  • Antimicrobial efficacy(Changes in bacterial levels from baseline to 6 months)

研究者

发起方
University of Taubate
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Roberto Cortelli

Head of Periodontics Department

University of Taubate

研究点 (2)

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Treatment of Periodontitis in Obese Individuals | 临床试验