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Completed

NCT Number: NCT01046435

Effects of Periodontal Therapy on Systemic Inflammation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically diagnosis of marginal periodontitis
  • No history of periodontal treatment
  • At least 14 natural teeth present
  • Dyslipidemia
  • And at least one of the following factors:
  • obesity
  • diabetes
  • smoking, hypertension

Exclusion criteria

  • Rheumatoid arthritis
  • Any type of cancer in the previous 2 years
  • Pregnancy and lactation
  • Indication of the use of antibiotic for invasive procedures
  • Use of antibiotics in previous three months.

Treatment and study plan

metronidazole and amoxicillin

Procedure

Metronidazole 250 mg three times a day per 7 days

Other names: Non-surgical periodontal therapy

Two placebos

Procedure

Two placebos 3 times a day for 7 days

Other names: Community periodontal treatment

Primary outcomes

  1. Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count

    Time frame: 0, 3, 6, 9 and 12 months after therapy

Secondary outcomes

  1. Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level

    Time frame: 0, 3, 6, 9 and 12 months after therapy

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 12, 2010
Registry last updated
Mar 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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