PeriodontitisNCT02150005
Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles in Patients With Coronariopathies
A study testing Periodontal treatment in people with Periodontitis and Coronariopathy, run by Universidade Veiga de Almeida.
Trial summary
Objective: The aim of this study was to examine the effects of non-surgical periodontal treatment on the hemogram, glycemic and lipid profiles in cardiopathic patients with an indication for surgical revascularization. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Periodontitis, Coronariopathy
- What is being tested?
- 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
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing cardiovascular treatment;
- Eight viable teeth in the oral cavity;
- Four periodontal sites with periodontal probing depths ≥5mm in different teeth.
Who cannot join
- -
About this study
Official title: Effects of Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles of Patients With an Indication for Surgical Coronary Revascularization
Objective: The aim of this study was to examine the effects of non-surgical periodontal treatment on the hemogram, glycemic and lipid profiles in cardiopathic patients with an indication for surgical revascularization.
Materials and Methods: Twenty-two patients with chronic periodontitis, over 35 years of age (mean age 59.45 years) randomly assigned into 2 groups were evaluated. Test group (n=11), received periodontal treatment before the surgical procedure, and control group (n=11), did not received periodontal treatment prior to surgery.
- Conditions
- Periodontitis, Coronariopathy
- Being tested
- Periodontal treatment
- Keywords
- periodontal diseases, cardiovascular diseases, periodontitis treatment
- Medical subject headings
- Periodontitis, Periodontal Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Periodontal treatment | Experimental | The test group received oral hygiene instructions, supragingival and subgingival scaling and root planning using curettes and an ultrasonic appliance. Receives: Procedure: Periodontal treatment |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in probing depth in sites with PPD>3mm
Reduction of 11.4% in probing depth in sites with Periodontal Probing Depth>3mm
Measured: Baseline and 90 days after the initial exam
Reduction in probing depth in sites with PPD>5mm
Reduction of 6.3% in probing depth in sites with Periodontal Probing Depth>5mm
Measured: Baseline and 90 days after the initial exam
Reduction in probing depth in sites with CAL>3mm
Reduction of 4.6% in probing depth in sites with Clinical Attachment Level >3mm.
Measured: Baseline and 90 days after the initial exam
Reduction in probing depth in sites with CAL >5mm
Reduction of 3.6% in probing depth in sites with Clinical Attachment Level >5mm.
Measured: Baseline and 90 days after the initial exam
Leukocyte count
Non-significant reduction of leukocyte count in the test group. Mean difference of 74.6 m/mcL.
Measured: Baseline and 90 days after the initial exam
Glucose
Glucose showed a non-significant increase in the test group. Mean difference of 24.2 mg/dL.
Measured: Baseline and 90 days after the initial exam
Hemocyte
Hemocyte presented a non-significant reduction in the test group. Mean difference 0.39 m/mcL
Measured: Baseline and 90 days after initial exam
Hemoglobin
Non-significant reduction in test group. Mean difference of 0.2 g/dL
Measured: Baseline and 90 days after initial exam
Total Cholesterol
Significant reduction in the test group. Mean reduction of 27.4 mg/dL.
Measured: Baseline and 90 days after initial exam
High density lipid
Significant reduction in test group. Mean difference of 8.2 mg/dL.
Measured: Baseline and 90 days after initial exam
Low density lipid
Non-significant reduction in test group. Mean difference of 8.9 mg/dL.
Measured: Baseline and 90 days after initial exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJan 2009
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Veiga de Almeida
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Walmir Júnio de Pinho Reis Rodrigues, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150005
- Sponsor's protocol ID
- UVA71/06
- Status last verified
- May 2014
- First submitted
- 18 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles of Patients With an Indication for Surgical Coronary Revascularization
- ClinicalTrials.gov ID
- NCT02150005
- Acronym / sponsor ID
- UVA71/06
- Conditions
- Periodontitis, Coronariopathy
- Keywords
- periodontal diseases, cardiovascular diseases, periodontitis treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidade Veiga de AlmeidaUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- First posted
- 29 May 2014 (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.
Objective: The aim of this study was to examine the effects of non-surgical periodontal treatment on the hemogram, glycemic and lipid profiles in cardiopathic patients with an indication for surgical revascularization.
Materials and Methods: Twenty-two patients with chronic periodontitis, over 35 years of age (mean age 59.45 years) randomly assigned into 2 groups were evaluated. Test group (n=11), received periodontal treatment before the surgical procedure, and control group (n=11), did not received periodontal treatment prior to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal treatment | Experimental | Procedure: Periodontal treatmentThe test group received oral hygiene instructions, supragingival and subgingival scaling and root planning using curettes and an ultrasonic appliance. |
| Control | No intervention | – |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing cardiovascular treatment;
- Eight viable teeth in the oral cavity;
- Four periodontal sites with periodontal probing depths ≥5mm in different teeth.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Periodontal treatment | Procedure or surgery | Periodontal treatment |
Primary outcome
Reduction in probing depth in sites with PPD>3mm
Time frame: Baseline and 90 days after the initial exam
Reduction of 11.4% in probing depth in sites with Periodontal Probing Depth>3mm
Reduction in probing depth in sites with PPD>5mm
Time frame: Baseline and 90 days after the initial exam
Reduction of 6.3% in probing depth in sites with Periodontal Probing Depth>5mm
Reduction in probing depth in sites with CAL>3mm
Time frame: Baseline and 90 days after the initial exam
Reduction of 4.6% in probing depth in sites with Clinical Attachment Level >3mm.
Reduction in probing depth in sites with CAL >5mm
Time frame: Baseline and 90 days after the initial exam
Reduction of 3.6% in probing depth in sites with Clinical Attachment Level >5mm.
Leukocyte count
Time frame: Baseline and 90 days after the initial exam
Non-significant reduction of leukocyte count in the test group. Mean difference of 74.6 m/mcL.
Glucose
Time frame: Baseline and 90 days after the initial exam
Glucose showed a non-significant increase in the test group. Mean difference of 24.2 mg/dL.
Hemocyte
Time frame: Baseline and 90 days after initial exam
Hemocyte presented a non-significant reduction in the test group. Mean difference 0.39 m/mcL
Hemoglobin
Time frame: Baseline and 90 days after initial exam
Non-significant reduction in test group. Mean difference of 0.2 g/dL
Total Cholesterol
Time frame: Baseline and 90 days after initial exam
Significant reduction in the test group. Mean reduction of 27.4 mg/dL.
High density lipid
Time frame: Baseline and 90 days after initial exam
Significant reduction in test group. Mean difference of 8.2 mg/dL.
Low density lipid
Time frame: Baseline and 90 days after initial exam
Non-significant reduction in test group. Mean difference of 8.9 mg/dL.
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 29 May 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal treatment in people with Periodontitis and Coronariopathy, run by Universidade Veiga de Almeida.
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 3 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 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Reduction in probing depth in sites with PPD>3mm (time frame: Baseline and 90 days after the initial exam). The study lists 11 primary outcomes in all. 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 29 May 2014.