Effects of Periodontal Therapy on Systemic Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Periodontal Disease Cardiovascular Disease Type 2 Diabetes Obesity Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Supragingival scaling plus placebo

Plaque control instructions, supra gingival scaling and two placebos

Group Type PLACEBO_COMPARATOR

metronidazole and amoxicillin

Intervention Type PROCEDURE

Metronidazole 250 mg three times a day per 7 days

Two placebos

Intervention Type PROCEDURE

Two placebos 3 times a day for 7 days

Root planing plus antibiotics

Plaque control instructions, subgingival scaling,root planing, metronidazole 250 mg and amoxicillin 500 mg. three times a day for 7 days

Group Type EXPERIMENTAL

metronidazole and amoxicillin

Intervention Type PROCEDURE

Metronidazole 250 mg three times a day per 7 days

Two placebos

Intervention Type PROCEDURE

Two placebos 3 times a day for 7 days

Interventions

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metronidazole and amoxicillin

Metronidazole 250 mg three times a day per 7 days

Intervention Type PROCEDURE

Two placebos

Two placebos 3 times a day for 7 days

Intervention Type PROCEDURE

Other Intervention Names

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Non-surgical periodontal therapy Community periodontal treatment

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No