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

NCT01433744 | Completed DMC

• 1 other identifier: 5209/2009
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis; Atherosclerotic Cardiovascular Disease

Keywords

C-Reactive protein; risk

Outcome Measures

Primary Outcomes (1)

• C-Reactive Protein levels

  Baseline and 60 days after treatment

Secondary Outcomes (1)

• The effect of non-surgical periodontal treatment on patients with chronic periodontitis

  Baseline and re-evaluation 60 days after the end of treatment

Study Arms (2)

Chronic periodontal disease

EXPERIMENTAL

C-reactive protein levels assesments and periodontal treatment

Procedure: Non-surgical periodontal treatment

Periodontally healthy

NO INTERVENTION

Interventions

Non-surgical periodontal treatment PROCEDURE

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.

Chronic periodontal disease

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• State University of Maringá: lead

Study Sites (1)

Departament of Dentistry of State University of Maringá

Maringá, Paraná, 87080000, Brazil

Location

MeSH Terms

Conditions

Chronic Periodontitis; Atherosclerosis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: September 14, 2011
• Study Start: January 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 14, 2011

Record last verified: 2011-09

Locations

BR (1)