An interventional study of metronidazole and amoxicillin and Two placebos in Periodontal Disease, Cardiovascular Disease and Type 2 Diabetes, sponsored by University of Chile. Completed at 1 site in Chile. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-03-25.
Sponsored by University of Chile · Not applicable, Interventional, and Treatment
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.
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.
830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.
This study's enrollment of 186 is above the median of 45 across 530 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
And at least one of the following factors:
Exclusion Criteria:
Plaque control instructions, supra gingival scaling and two placebos
Procedure: metronidazole and amoxicillin · Procedure: Two placebos
Plaque control instructions, subgingival scaling,root planing, metronidazole 250 mg and amoxicillin 500 mg. three times a day for 7 days
Procedure: metronidazole and amoxicillin · Procedure: Two placebos
Metronidazole 250 mg three times a day per 7 days
Also known as: Non-surgical periodontal therapy
Two placebos 3 times a day for 7 days
Also known as: Community periodontal treatment
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
Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level
Time frame: 0, 3, 6, 9 and 12 months after therapy
This study is completed, as verified in May 2006. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Chile