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

January 11, 2010
March 24, 2010
March 2007
March 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01046435 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Effects of Periodontal Therapy on Systemic Inflammation
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Periodontal Disease
  • Cardiovascular Disease
  • Type 2 Diabetes
  • Obesity
  • Metabolic Syndrome
  • 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
  • Placebo Comparator: Supragingival scaling plus placebo
    Plaque control instructions, supra gingival scaling and two placebos
    Interventions:
    • Procedure: metronidazole and amoxicillin
    • Procedure: Two placebos
  • 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
    Interventions:
    • Procedure: metronidazole and amoxicillin
    • Procedure: Two placebos
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT01046435
FONDECYT 1061070
Yes
Nestor J. Lopez, University of Chile Faculty of Dentistry
University of Chile
Not Provided
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
University of Chile
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP