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Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01433744
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : September 14, 2011
Information provided by (Responsible Party):
André Barbisan de Souza, State University of Maringá

Brief Summary:
The hypotheses tested were that levels of C-Reactive Protein (CRP) would be higher in patients with chronic periodontitis in comparison with those without periodontal disease and that the non-surgical periodontal treatment would decrease levels of CRP in patients with chronic periodontitis.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Atherosclerotic Cardiovascular Disease Procedure: Non-surgical periodontal treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment
Study Start Date : January 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: Chronic periodontal disease
C-reactive protein levels assesments and periodontal treatment
Procedure: Non-surgical periodontal treatment
Patients included in the test group were submitted to a non-surgical periodontal treatment protocol, which consisted of oral hygiene orientation and motivation followed by mechanical plaque control involving scaling and root planning using Gracey curets (Hu-Friedy Manufacturing, Chicago, IL, USA) and ultrasonic instrumentation (Cavitron Ultrasonics, Long Island City, NY, USA), under local anesthesia (Mepivacaine 2% with epinephrine 1:100000). The treatment was performed in one or two sessions depending on the extension of the patient's periodontal condition. Patients that presented teeth unreasonable to treat due to advanced periodontitis, or any other condition were extracted under local anesthesia.

No Intervention: Periodontally healthy

Primary Outcome Measures :
  1. C-Reactive Protein levels [ Time Frame: Baseline and 60 days after treatment ]

Secondary Outcome Measures :
  1. The effect of non-surgical periodontal treatment on patients with chronic periodontitis [ Time Frame: Baseline and re-evaluation 60 days after the end of treatment ]

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Patients should have ≥ 20 teeth present; (ii) absence of oral soft tissue lesions; (iii) have ≤ 3 carious lesions in all teeth. In addition, to be included in the Test group the subject had to present chronic periodontitis (involvement of at least 5 teeth with at least one site presenting probing depth (PD) ≥ 5 mm and clinical attachment loss (CAL) ≥ 3 mm) while to be included in the Control group the patient had to exhibit periodontal healthy (bleeding on probing (BOP) < 30% of the sites and absence of any PD > 4mm associated with BOP).

Exclusion Criteria:

(i) periodontal disease treatment in the previous six months; (ii) aged less than 35 years; (iii) systemic conditions such as history of CVD or any other chronic or immunologic diseases and the use of related drugs in the previous six months; (iv) smokers or former smokers; (v) pregnant or lactating women; (vi) hypertension (>140 systolic and > 90 diastolic mmHg); (vii) obesity (Body Mass Index (BMI) ≥ 30 kg/m²); (viii) levels of HDL-cholesterol > 35.0 mg/dL (ix) levels of LDL-cholesterol < 160.0 mg/dL (x)levels of triglycerides < 400.0 mg/dL and (xi) levels of glucose levels < 100 mg/dL.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01433744

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Departament of Dentistry of State University of Maringá
Maringá, Paraná, Brazil, 87080000
Sponsors and Collaborators
State University of Maringá

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Responsible Party: André Barbisan de Souza, DDS, State University of Maringá Identifier: NCT01433744     History of Changes
Other Study ID Numbers: 5209/2009
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011

Keywords provided by André Barbisan de Souza, State University of Maringá:
C-Reactive protein

Additional relevant MeSH terms:
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Cardiovascular Diseases
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Arterial Occlusive Diseases
Vascular Diseases