Effects of Periodontal Therapy on Systemic Inflammation

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046435
• Other study ID #: FONDECYT 1061070
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: March 24, 2010
• Start date: March 2007
• Est. completion date: March 2009

Study information

• Verified date: May 2006
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Gingival Diseases
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Periodontal Disease
• Periodontal Diseases
• Type 2 Diabetes

Intervention

Procedure:
• metronidazole and amoxicillin
Metronidazole 250 mg three times a day per 7 days
• Two placebos
Two placebos 3 times a day for 7 days

Locations

Country	Name	City	State
Chile	Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count		0, 3, 6, 9 and 12 months after therapy	No
Secondary	Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level		0, 3, 6, 9 and 12 months after therapy	No

External Links

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