Treatment of Periodontitis in Obese Individuals

Study Overview
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Brief Summary
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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.

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

Conditions
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Obese, Obesity, Morbid, Periodontitis

Intervention / Treatment
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* Combination Product: One-stage full-mouth disinfection with chlorhexidine


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal weight full-mouth disinfection<br>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 | Combination Product: One-stage full-mouth disinfection with chlorhexidine<br>* Mechanical procedures, composed of full-mouth dental scaling and root planning and dental prophylaxis, will be completed within 24 hours (2 appointments in 2 consecutive mornings or afternoons). Chlorhexidine will be used as the antimicrobial agent in different concentrations (0.2%, 1% and 2%) and vehicles (solution, gel). Oral hygiene instructions will be given for all participants.<br>|
| Experimental: Overweight full-mouth disinfection<br>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 | Combination Product: One-stage full-mouth disinfection with chlorhexidine<br>* Mechanical procedures, composed of full-mouth dental scaling and root planning and dental prophylaxis, will be completed within 24 hours (2 appointments in 2 consecutive mornings or afternoons). Chlorhexidine will be used as the antimicrobial agent in different concentrations (0.2%, 1% and 2%) and vehicles (solution, gel). Oral hygiene instructions will be given for all participants.<br>|
| Experimental: Obesity I full-mouth disinfection<br>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 | Combination Product: One-stage full-mouth disinfection with chlorhexidine<br>* Mechanical procedures, composed of full-mouth dental scaling and root planning and dental prophylaxis, will be completed within 24 hours (2 appointments in 2 consecutive mornings or afternoons). Chlorhexidine will be used as the antimicrobial agent in different concentrations (0.2%, 1% and 2%) and vehicles (solution, gel). Oral hygiene instructions will be given for all participants.<br>|
| Experimental: Obesity II full-mouth disinfection<br>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 | Combination Product: One-stage full-mouth disinfection with chlorhexidine<br>* Mechanical procedures, composed of full-mouth dental scaling and root planning and dental prophylaxis, will be completed within 24 hours (2 appointments in 2 consecutive mornings or afternoons). Chlorhexidine will be used as the antimicrobial agent in different concentrations (0.2%, 1% and 2%) and vehicles (solution, gel). Oral hygiene instructions will be given for all participants.<br>|
| Experimental: Obesity III full-mouth disinfection<br>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 | Combination Product: One-stage full-mouth disinfection with chlorhexidine<br>* Mechanical procedures, composed of full-mouth dental scaling and root planning and dental prophylaxis, will be completed within 24 hours (2 appointments in 2 consecutive mornings or afternoons). Chlorhexidine will be used as the antimicrobial agent in different concentrations (0.2%, 1% and 2%) and vehicles (solution, gel). Oral hygiene instructions will be given for all participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal clinical efficacy | Improvements in periodontal pocket depth (mm) overtime and comparisons among groups at 6 months after treatment | Changes in periodontal pocket depth measurements from baseline to 6 months | 
| Periodontal clinical efficacy | Improvements in clinical attachment level (mm) overtime and comparisons among groups at 6 months after treatment | Changes in clinical attachment measurements from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial efficacy | Reductions in total bacterial levels and levels of target bacterial species overtime and comparisons among groups at 6 months after treatment | Changes in total bacterial levels from baseline to 6 months | 
| Antimicrobial efficacy | Reductions in Treponema denticola, Porphyromonas gingivalis, Tannerella forsythia, Aggregatibacter actinomycetemcomitans levels overtime and comparisons among groups at 6 months after treatment | Changes in bacterial levels from baseline to 6 months | 
| Oral safety and tolerability | Maintenance of salivary nitrite levels overtime and comparisons among groups at 6 months after treatment | Changes in salivary nitrite levels from baseline to 6 months | 
| Impact on quality of life | Improvements in Oral health and quality of life - United Kingdom questionnaire scores overtime and comparisons among groups at 6 months after treatment | Changes in scores (Likert scale ranging from 16 to 80 points) of Oral health and quality of life - United Kingdom questionnaire from baseline to 6 months | 
| Impact on quality of life | Improvements in Oral impacts on daily performance questionnaire scores overtime and comparisons among groups at 6 months after treatment | Changes in scores (Likert scale ranging from 0 to 56 points) of Oral impacts on daily performance questionnaire from baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Periodontitis, Therapeutics, Chlorhexidine