Obese, Obesity, Morbid, Periodontitis
Conditions
Keywords
Obesity, Periodontitis, Therapeutics, Chlorhexidine
Brief summary
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.
Interventions
COMBINATION_PRODUCTOne-stage full-mouth disinfection with chlorhexidine
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.
Sponsors
University of Taubate
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal clinical efficacy | Changes in periodontal pocket depth measurements from baseline to 6 months | Improvements in periodontal pocket depth (mm) overtime and comparisons among groups at 6 months after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antimicrobial efficacy | Changes in total bacterial levels from baseline to 6 months | Reductions in total bacterial levels and levels of target bacterial species overtime and comparisons among groups at 6 months after treatment |
| Oral safety and tolerability | Changes in salivary nitrite levels from baseline to 6 months | Maintenance of salivary nitrite levels overtime and comparisons among groups at 6 months after treatment |
| Impact on quality of life | 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 | Improvements in Oral health and quality of life - United Kingdom questionnaire scores overtime and comparisons among groups at 6 months after treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Systemic effects | Changes in in glycemic levels from baseline to 6 months. | Glycemic blood levels. |
Countries
Brazil
Outcome results
None listed