Treatment of Periodontitis in Obese Individuals
Condition: Obese; Obesity, Morbid; Periodontitis
MeSH terms: Periodontitis; Obesity, Morbid
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): One-stage full-mouth disinfection with chlorhexidine
Intervention type(s): Combination Product
Intervention description(s): 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.
Intervention MeSH terms: Chlorhexidine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Periodontitis; Therapeutics; Chlorhexidine