Effects of Periodontal Therapy on Systemic Inflammation
Primary Purpose
Periodontal Disease, Cardiovascular Disease, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
metronidazole and amoxicillin
Two placebos
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Disease focused on measuring periodontitis, cardiovascular disease, diabetes
Eligibility 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.
Sites / Locations
- Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Supragingival scaling plus placebo
Root planing plus antibiotics
Arm Description
Plaque control instructions, supra gingival scaling and two placebos
Plaque control instructions, subgingival scaling,root planing, metronidazole 250 mg and amoxicillin 500 mg. three times a day for 7 days
Outcomes
Primary Outcome Measures
Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count
Secondary Outcome Measures
Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01046435
Brief Title
Effects of Periodontal Therapy on Systemic Inflammation
Official Title
Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Chile
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease, Cardiovascular Disease, Type 2 Diabetes, Obesity, Metabolic Syndrome
Keywords
periodontitis, cardiovascular disease, diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supragingival scaling plus placebo
Arm Type
Placebo Comparator
Arm Description
Plaque control instructions, supra gingival scaling and two placebos
Arm Title
Root planing plus antibiotics
Arm Type
Experimental
Arm Description
Plaque control instructions, subgingival scaling,root planing, metronidazole 250 mg and amoxicillin 500 mg. three times a day for 7 days
Intervention Type
Procedure
Intervention Name(s)
metronidazole and amoxicillin
Other Intervention Name(s)
Non-surgical periodontal therapy
Intervention Description
Metronidazole 250 mg three times a day per 7 days
Intervention Type
Procedure
Intervention Name(s)
Two placebos
Other Intervention Name(s)
Community periodontal treatment
Intervention Description
Two placebos 3 times a day for 7 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level
Time Frame
0, 3, 6, 9 and 12 months after therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nestor J. Lopez, DDS
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Quintero, DDS
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carola Ibieta, DDS
Organizational Affiliation
University of Chile
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos Y Valenzuela, DMS, PhD
Organizational Affiliation
University of Chile
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lilian Jara, MsB, PhD
Organizational Affiliation
University of Chile
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marcelo Llancaqueo, DMS
Organizational Affiliation
University of Chile
Official's Role
Study Chair
Facility Information:
Facility Name
Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service
City
Santiago
Country
Chile
12. IPD Sharing Statement
Links:
URL
http://www.fondecyt.cl/578/channel.html
Description
Related Info
Learn more about this trial
Effects of Periodontal Therapy on Systemic Inflammation
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