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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal weight full-mouth disinfection | Experimental |
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| Overweight full-mouth disinfection | Experimental |
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| Obesity I full-mouth disinfection | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-stage full-mouth disinfection with chlorhexidine | Combination Product | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic effects | Glycemic blood levels. | Changes in in glycemic levels from baseline to 6 months. |
| Systemic effects | Blood levels of high density lipoprotein-cholesterol, low density lipoprotein -cholesterol, very low density lipoprotein - fractions levels parameters. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose R Cortelli, PhD | Associate professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Taubate | Taubaté | São Paulo | 12020330 | Brazil |
IPD will not be shared
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Obesity II full-mouth disinfection | Experimental |
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| Obesity III full-mouth disinfection | Experimental |
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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 |
| Changes in blood levels of high density lipoprotein-cholesterol, low density lipoprotein -cholesterol and very low density lipoprotein - fractions from baseline to 6 months. |
| Systemic effects | Blood counts of white cells, red cells and platelets. | Changes in blood counts of white cells, red cells and platelets from baseline to 6 months. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |