Clinical trial NCT01046435: Effects of Periodontal Therapy on Systemic Inflammation
Official title: Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Disease
Cardiovascular Disease
Type 2 Diabetes
Obesity
Metabolic Syndrome
Keywords: periodontitis
cardiovascular disease
diabetes
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2010-01-12
Enrollment: 186
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count
timeFrame: 0, 3, 6, 9 and 12 months after therapy
Secondary outcomes:
measure: Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level
timeFrame: 0, 3, 6, 9 and 12 months after therapy
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service
Study officials:
affiliation: University of Chile
name: Nestor J. Lopez, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Antonio Quintero, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Carola Ibieta, DDS
role: STUDY_CHAIR
affiliation: University of Chile
name: Carlos Y Valenzuela, DMS, PhD
role: STUDY_CHAIR
affiliation: University of Chile
name: Lilian Jara, MsB, PhD
role: STUDY_CHAIR
affiliation: University of Chile
name: Marcelo Llancaqueo, DMS
role: STUDY_CHAIR
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