Effects of Periodontal Therapy on Systemic Inflammation
Condition: Periodontal Disease; Cardiovascular Disease; Type 2 Diabetes; Obesity; Metabolic Syndrome
MeSH terms: Periodontal Diseases; Cardiovascular Diseases; Metabolic Syndrome; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine if treating periodontal infections (gum disease)
      will reduce markers of systemic inflammation in patients at risk of cardiovascular diseases.
    

Detailed description: 
      Aims: To determine the effects of periodontal treatment on systemic markers of inflammation
      in subjects with risk of coronary heart disease.

      Methods: The current study is a randomized, double blind clinical trial, with two treatment
      groups.

      Eligible participants will be allocated by restricted randomization using the minimization
      method to the treatment group or to the control group. The treatment group will receive
      periodontal therapy consisting of instructions of plaque control, supra and subgingival
      scaling and root planing, oral systemic metronidazole (250 mg) plus amoxicillin (500 mg) tid
      for 7 days. The control group will receive plaque control instructions, supragingival scaling
      and two placebos. The study plan to enroll 160 participants, 80 in ech arm, over a 6-month
      period. Follow-up clinic visits will be scheduled to occur every 3 months after finishing
      treatment. Baseline and follow-up clinic visits will include periodontal examination, blood
      collection and medical and dental histories. The following biochemical markers will be
      determined at baseline and at 3, 6, 9 and 12 months posttherapy: total, LDL and HDL
      lipoprotein cholesterol and triglycerides, glycemia, high sensitivity C-reactive protein,
      fibrinogen, erythrocyte sedimentation rate and white blood cells count. In diabetic patients,
      glycosylated hemoglobin will be also assessed.

      The study will be conducted in a public health center in Santiago, Chile. To be eligible for
      the study, participants have to be older than 35 years and fulfill the medical and
      periodontal criteria. For the medical criteria participants have to have dyslipidemia, and at
      least one of the following coronary heart disease risk factors: obesity, smoking, diabetes,
      hypertension.

      The periodontal inclusion criteria are: no history of periodontal treatment, the presence of
      at least 14 natural teeth, with at least 4 teeth with interproximal sites with probing depth
      equal or higher than 4 mm and concomitant attachment loss equal or higher than 3 mm, and >30
      % of sites with bleeding on probing.

      The outcomes measures will be levels of serum C-reactive protein, fibrinogen,
      erythrosedimentation rate, white blood cell count.The outcomes will be measured at 0, 3,6,9,
      and 6 months after periodontal therapy.
    

Intervention name(s): metronidazole and amoxicillin; Two placebos
Intervention type(s): Procedure; Procedure
Intervention description(s): Metronidazole 250 mg three times a day per 7 days; Two placebos 3 times a day for 7 days
Other intervention name(s): Non-surgical periodontal therapy; Community periodontal treatment
Intervention MeSH terms: Amoxicillin; Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontitis; cardiovascular disease; diabetes