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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433744
• Other study ID #: 5209/2009
• Status: Completed
• Phase: N/A
• First received: September 12, 2011
• Last updated: September 13, 2011
• Start date: January 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: State University of Maringá
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Periodontitis
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Brazil	Departament of Dentistry of State University of Maringá	Maringá	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
State University of Maringá

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-Reactive Protein levels		Baseline and 60 days after treatment	Yes
Secondary	The effect of non-surgical periodontal treatment on patients with chronic periodontitis		Baseline and re-evaluation 60 days after the end of treatment	Yes