- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01433744
Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Paraná
-
Maringá, Paraná, Brazil, 87080000
- Departament of Dentistry of State University of Maringá
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chronic periodontal disease
C-reactive protein levels assesments and 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
C-Reactive Protein levels
Time Frame: Baseline and 60 days after treatment
|
Baseline and 60 days after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Baseline and re-evaluation 60 days after the end of treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5209/2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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