Effects of Periodontal Therapy on Systemic Inflammation

March 24, 2010 updated by: University of Chile

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Supragingival scaling plus placebo
Plaque control instructions, supra gingival scaling and two placebos
Procedure: metronidazole and amoxicillin
Metronidazole 250 mg three times a day per 7 days
Other Names:
  • Non-surgical periodontal therapy
Procedure: Two placebos
Two placebos 3 times a day for 7 days
Other Names:
  • Community periodontal treatment
Experimental: 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
Procedure: metronidazole and amoxicillin
Metronidazole 250 mg three times a day per 7 days
Other Names:
  • Non-surgical periodontal therapy
Procedure: Two placebos
Two placebos 3 times a day for 7 days
Other Names:
  • Community periodontal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0, 3, 6, 9 and 12 months after therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level
Time Frame: 0, 3, 6, 9 and 12 months after therapy
0, 3, 6, 9 and 12 months after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Investigators

  • Principal Investigator: Nestor J. Lopez, DDS, University of Chile
  • Principal Investigator: Antonio Quintero, DDS, University of Chile
  • Study Chair: Carola Ibieta, DDS, University of Chile
  • Study Chair: Carlos Y Valenzuela, DMS, PhD, University of Chile
  • Study Chair: Lilian Jara, MsB, PhD, University of Chile
  • Study Chair: Marcelo Llancaqueo, DMS, University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

March 25, 2010

Last Update Submitted That Met QC Criteria

March 24, 2010

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FONDECYT 1061070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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