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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
André Barbisan de Souza, State University of Maringá
ClinicalTrials.gov Identifier:
NCT01433744
First received: September 12, 2011
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

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 Intervention
Chronic Periodontitis
Atherosclerotic Cardiovascular Disease
Procedure: Non-surgical periodontal treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment

Resource links provided by NLM:


Further study details as provided by State University of Maringá:

Primary Outcome Measures:
  • C-Reactive Protein levels [ Time Frame: Baseline and 60 days after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01433744

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

No publications provided

Responsible Party: André Barbisan de Souza, DDS, State University of Maringá
ClinicalTrials.gov Identifier: NCT01433744     History of Changes
Other Study ID Numbers: 5209/2009
Study First Received: September 12, 2011
Last Updated: September 13, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by State University of Maringá:
C-Reactive protein
risk

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

ClinicalTrials.gov processed this record on July 29, 2014