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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 12, 2011
Last Updated Date	September 13, 2011
Start Date ^ICMJE	January 2010
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 13, 2011)	C-Reactive Protein levels [ Time Frame: Baseline and 60 days after treatment ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01433744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 13, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment
Official Title ^ICMJE	Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Chronic Periodontitis Atherosclerotic Cardiovascular Disease
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Chronic periodontal disease C-reactive protein levels assesments and periodontal treatment Intervention: Procedure: Non-surgical periodontal treatment No Intervention: Periodontally healthy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	44
Completion Date	July 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	35 Years to 75 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01433744
Other Study ID Numbers ^ICMJE	5209/2009
Has Data Monitoring Committee	Yes
Responsible Party	André Barbisan de Souza, State University of Maringá
Study Sponsor ^ICMJE	State University of Maringá
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	State University of Maringá
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top