Effects of Periodontal Therapy on Systemic Inflammation

This study has been completed.
Sponsor:
Information provided by:
University of Chile
ClinicalTrials.gov Identifier:
NCT01046435
First received: January 11, 2010
Last updated: March 24, 2010
Last verified: May 2006
  Purpose

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.


Condition Intervention
Periodontal Disease
Cardiovascular Disease
Type 2 Diabetes
Obesity
Metabolic Syndrome
Procedure: metronidazole and amoxicillin
Procedure: Two placebos

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk

Resource links provided by NLM:


Further study details as provided by University of Chile:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level [ Time Frame: 0, 3, 6, 9 and 12 months after therapy ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: March 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Non-surgical periodontal therapy
Procedure: Two placebos
Two placebos 3 times a day for 7 days
Other Name: 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 Name: Non-surgical periodontal therapy
Procedure: Two placebos
Two placebos 3 times a day for 7 days
Other Name: Community periodontal 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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046435

Locations
Chile
Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service
Santiago, Chile
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Nestor J. Lopez, University of Chile Faculty of Dentistry
ClinicalTrials.gov Identifier: NCT01046435     History of Changes
Other Study ID Numbers: FONDECYT 1061070
Study First Received: January 11, 2010
Last Updated: March 24, 2010
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by University of Chile:
periodontitis
cardiovascular disease
diabetes

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Inflammation
Obesity
Periodontal Diseases
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Insulin Resistance
Hyperinsulinism
Amoxicillin
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 21, 2014