Chronic PeriodontitisNCT01433744
Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment
A study testing Non-surgical periodontal treatment in people with Chronic Periodontitis and Atherosclerotic Cardiovascular Disease, run by State University of Maringá at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Atherosclerotic Cardiovascular Disease
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Departament of Dentistry of State University of Maringá
Maringá, Paraná, 87080000
About this study
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.
- Being tested
- Non-surgical periodontal treatment
- Keywords
- C-Reactive protein, risk
- Medical subject headings
- Chronic Periodontitis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Chronic periodontal disease | Experimental | C-reactive protein levels assesments and periodontal treatment Receives: Procedure: Non-surgical periodontal treatment |
| Periodontally healthy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-Reactive Protein levels
Measured: Baseline and 60 days after treatment
Secondary outcomes (1)
The effect of non-surgical periodontal treatment on patients with chronic periodontitis
Measured: Baseline and re-evaluation 60 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startJan 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of Maringá
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Barbisan de Souza, State University of Maringá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433744
- Sponsor's protocol ID
- 5209/2009
- Status last verified
- Sep 2011
- First submitted
- 12 Sep 2011
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment
- ClinicalTrials.gov ID
- NCT01433744
- Acronym / sponsor ID
- 5209/2009
- Keywords
- C-Reactive protein, risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- State University of MaringáUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic periodontal disease | Experimental | Procedure: Non-surgical periodontal treatmentC-reactive protein levels assesments and periodontal treatment |
| Periodontally healthy | No intervention | – |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical periodontal treatmentPatients 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. | Procedure or surgery | Chronic periodontal disease |
Primary outcome
C-Reactive Protein levels
Time frame: Baseline and 60 days after treatment
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment in people with Chronic Periodontitis and Atherosclerotic Cardiovascular Disease, run by State University of Maringá at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-Reactive Protein levels (time frame: Baseline and 60 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2011; AzTrials last refreshed its copy on 29 Oct 2026.