Clinical trial NCT03103204: Treatment of Periodontitis in Obese Individuals
Official title: Clinical, Microbial and Biochemistry Evaluation of Obese Individuals Submitted to One-stage Full-mouth Disinfection. A Clinical Control Parallel Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obese
Obesity, Morbid
Periodontitis
Keywords: Obesity
Periodontitis
Therapeutics
Chlorhexidine
Lead sponsor: University of Taubate
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Periodontal clinical efficacy
timeFrame: Changes in periodontal pocket depth measurements from baseline to 6 months
measure: Periodontal clinical efficacy
timeFrame: Changes in clinical attachment measurements from baseline to 6 months
Secondary outcomes:
measure: Antimicrobial efficacy
timeFrame: Changes in total bacterial levels from baseline to 6 months
measure: Antimicrobial efficacy
timeFrame: Changes in bacterial levels from baseline to 6 months
measure: Oral safety and tolerability
timeFrame: Changes in salivary nitrite levels from baseline to 6 months
measure: Impact on quality of life
timeFrame: 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
measure: Impact on quality of life
timeFrame: Changes in scores (Likert scale ranging from 0 to 56 points) of Oral impacts on daily performance questionnaire from baseline to 6 months
Other outcomes:
measure: Systemic effects
timeFrame: Changes in in glycemic levels from baseline to 6 months.
measure: Systemic effects
timeFrame: Changes in blood levels of high density lipoprotein-cholesterol, low density lipoprotein -cholesterol and very low density lipoprotein - fractions from baseline to 6 months.
measure: Systemic effects
timeFrame: Changes in blood counts of white cells, red cells and platelets from baseline to 6 months.
Locations:
city: Taubate
country: Brazil
facility: University of Taubate
state: Sao Paulo
Study officials:
affiliation: Associate professor
name: Jose R Cortelli, PhD
role: PRINCIPAL_INVESTIGATOR
References: