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

Primary Purpose

Chronic Periodontitis, Atherosclerotic Cardiovascular Disease

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Non-surgical periodontal treatment

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring C-Reactive protein, risk

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Departament of Dentistry of State University of Maringá

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chronic periodontal disease

Periodontally healthy

Arm Description

C-reactive protein levels assesments and periodontal treatment

Outcomes

Primary Outcome Measures

C-Reactive Protein levels

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01433744

First Posted

September 12, 2011

Last Updated

September 13, 2011

Sponsor

State University of Maringá

1. Study Identification

Unique Protocol Identification Number

NCT01433744

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

State University of Maringá

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis, Atherosclerotic Cardiovascular Disease

Keywords

C-Reactive protein, risk

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Non-Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chronic periodontal disease

Arm Type

Experimental

Arm Description

C-reactive protein levels assesments and periodontal treatment

Arm Title

Periodontally healthy

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

Non-surgical periodontal treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

C-Reactive Protein levels

Time Frame

Baseline and 60 days after treatment

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Departament of Dentistry of State University of Maringá

City

Maringá

State/Province

Paraná

ZIP/Postal Code

87080000

Country

Brazil

12. IPD Sharing Statement

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

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