PeriodontitisPhase 3NCT00681564

Periodontal Infection and Endothelial Dysfunction

A Phase 3 study testing One-Stage Full-Mouth Disinfection and Periodontal care in people with Periodontitis, run by Universidad del Valle, Colombia at 2 sites in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the effect of periodontal therapy on endothelial function and other biomarkers of cardiovascular disease Read more about this study

Who is it for?: Ages 25 years and olderHealthy volunteers can take part
Conditions the study is for: Periodontitis
What is being tested?: One-Stage Full-Mouth Disinfection and Periodontal care
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 2 sitesColombia
Study dates: May 2008to Jan 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 25 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects must be 25 years of age or older
Three or more periodontal pockets with a probing depth (PD) > 5mm
Have at least 20 natural teeth
Provide informed consent and willingness to cooperate with the study protocol

Who cannot join

History of antibiotic use in the previous three months
Pregnant or lactating females
Treatment with antihypertensive, antilipemic, antiarrhythmic, and other cardiovascular drugs
Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
Previous history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular block, peripheral vascular disease, cerebrovascular accident
Patients who received periodontal treatment within the last 3 months
Patients who require antibiotic prophylaxis before examination or treatment
Patients with mental retardation and dementia

Trial locations and contacts

2 sites in 1 country.

Colombia2 sites

Red de Salud de Ladera E.S.E. Servicio de Odontología
Cali, Valle del Cauca Department
Universidad del Valle, Facultad de Salud, Escuela de Odontología
Cali, Valle del Cauca Department

Other trials in Colombia

About this study

Official title: Impact of Periodontal Therapy on Endothelial Function

The purpose of this study is to determine the effect of periodontal therapy on endothelial function and other biomarkers of cardiovascular disease

Read the detailed description

Periodontitis is one of the most prevalent chronic diseases and a frequent cause of tooth loss. Accumulation of subgingival dental biofilm in susceptible individuals is associated with an inflammatory host response characterized by the production of Matrix Metalloproteinases, reduction in collagen synthesis, increase in cytokine gene expression, and apoptosis of gingival fibroblasts. Finally, inflammation leads to destruction of periodontal ligament, alveolar bone resorption, and chronic periodontitis.

Periodontitis is associated with increased serum levels of inflammatory cytokines and acute phase reactants. Multiple case-control and cohort studies have suggested that periodontitis is an independent risk factor for cardiovascular events, diabetic end-organ damage, pregnancy complications and respiratory diseases. Recent interventional studies have found that periodontal therapy could increase endothelium-dependent brachial artery flow-mediated dilation.

The purpose of this controlled clinical trial is to determine the effect of periodontal therapy on endothelial function in subjects with moderate to severe chronic periodontitis. Furthermore, the relationship between putative periodontal pathogens and endothelial function will be also evaluated.

Conditions: Periodontitis
Being tested: One-Stage Full-Mouth Disinfection, Periodontal care
Keywords: Periodontitis, Oral health, Cardiovascular disease
Medical subject headings: Periodontitis, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

One-Stage Full-Mouth DisinfectionProcedure or surgery
- Scaling and root planing, four quadrants in one session
- Tongue brushing with a 1% chlorhexidine gel (1 minute)
- Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
- Subgingival chlorhexidine (1%) irrigation in all pockets
- Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
- Basic oral hygiene instructions
- Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
Periodontal careProcedure or surgery
- Basic oral hygiene instructions
- Supragingival plaque removal

Study groups in NCT00681564
Study group	Role	What they receive
One-Stage Full-Mouth Disinfection	Experimental	Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) Receives: Procedure: One-Stage Full-Mouth Disinfection
Periodontal care	Active comparator	Basic oral hygiene instructions Supragingival plaque removal Receives: Procedure: Periodontal care

What is being measured

The primary outcome is the main question the study is designed to answer.

Brachial Artery Flow-mediated Dilation
All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%).
Measured: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy

Secondary outcomes (11)

High-sensitivity C-Reactive Protein
The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens).
Measured: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Total Cholesterol
Measured: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
White Blood Cell Count
Measured: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Subgingival Microbiota
Polymerase chain reaction (PCR) was used for detection of the three red-complex periodontal pathogens in periodontal pockets: Porphyromonas gingivalis (Pg), Treponema denticola (Td) and Tannerella forsythia (Tf).
Measured: 12 weeks post-periodontal therapy
LDL Cholesterol
Measured: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)
Multiplexed immuno-cytometric assay for the simultaneous measurement of MMP-9, MPO, tPAI-1, E-Selectin, ICAM-1, and VCAM-1 in serum samples (Milliplex® MAP kit, Human Cardiovascular Disease Panel 1, Millipore®).
Luminex® 200™ IS Total System and xPONENT software were used for data acquisition and analysis.
Measured: 12 weeks post periodontal therapy
Intercellular Adhesion Molecule 1 (ICAM-1)
Measured: 12 weeks post periodontal therapy
Vascular Cell Adhesion Molecule 1 (VCAM-1)
Measured: 12 weeks post periodontal therapy
Myeloperoxidase (MPO)
Measured: 12 weeks post periodontal therapy
Matrix Metalloproteinase-9 (MMP-9)
Measured: 12 weeks post periodontal therapy
Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)
Measured: 12 weeks post periodontal therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Jan 2012

First posted21 May 2008 (estimated)
Study startMay 2008
Primary completionMar 2011
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
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 3
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00681564
Sponsor's protocol ID: COLCIENCIAS 110634319239
Status last verified: Mar 2014
First submitted: 19 May 2008
Last updated: 17 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ramirez JH, Parra B, Gutierrez S, Arce RM, Jaramillo A, Ariza Y, Contreras A. Biomarkers of cardiovascular disease are increased in untreated chronic periodontitis: a case control study. Aust Dent J. 2014 Mar;59(1):29-36. doi: 10.1111/adj.12139. Epub 2014 Feb 4.
PubMed 24495202
Ramirez JH, Arce RM, Contreras A. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. Trials. 2011 Feb 16;12:46. doi: 10.1186/1745-6215-12-46.
PubMed 21324167

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis: A Pilot Prospective Longitudinal Observational Cohort Study
Periodontitis (Stage 3), Periodontitis Stage IV
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
Active, not recruitingObservational study
Evaluation of MTHFR and DNMT3B Gene Polymorphisms Along With Periodontal Clinical Parameters in Healthy Individuals and Individuals With Type 2 Diabetes and Periodontitis
Periodontitis, Type 2 Diabetes Mellitus (DM)

All Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Periodontal Therapy on Endothelial Function
ClinicalTrials.gov ID: NCT00681564
Acronym / sponsor ID: COLCIENCIAS 110634319239
Conditions: Periodontitis
Keywords: Periodontitis, Oral health, Cardiovascular disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Universidad del Valle, ColombiaUniversity, hospital or other
Study start: May 2008
Primary completion: Mar 2011 (actual)
Study completion: Jan 2012 (actual)
First posted: 21 May 2008 (estimated)
Results: Posted 1 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the effect of periodontal therapy on endothelial function and other biomarkers of cardiovascular disease

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
One-Stage Full-Mouth Disinfection	Experimental	Procedure: One-Stage Full-Mouth DisinfectionScaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
Periodontal care	Active comparator	Procedure: Periodontal careBasic oral hygiene instructions Supragingival plaque removal

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects must be 25 years of age or older
Three or more periodontal pockets with a probing depth (PD) > 5mm
Have at least 20 natural teeth
Provide informed consent and willingness to cooperate with the study protocol

Key exclusion criteria (8 listed)

History of antibiotic use in the previous three months
Pregnant or lactating females
Treatment with antihypertensive, antilipemic, antiarrhythmic, and other cardiovascular drugs
Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
Previous history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular block, peripheral vascular disease, cerebrovascular accident

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
One-Stage Full-Mouth Disinfection* Scaling and root planing, four quadrants in one session * Tongue brushing with a 1% chlorhexidine gel (1 minute) * Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) * Subgingival chlorhexidine (1%) irrigation in all pockets * Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention * Basic oral hygiene instructions * Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)	Procedure or surgery	One-Stage Full-Mouth Disinfection
Periodontal care* Basic oral hygiene instructions * Supragingival plaque removal	Procedure or surgery	Periodontal care

Primary outcome

Brachial Artery Flow-mediated Dilation
Time frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%).

11 secondary outcomes

High-sensitivity C-Reactive Protein
Time frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Total Cholesterol
Time frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
White Blood Cell Count
Time frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Subgingival Microbiota
Time frame: 12 weeks post-periodontal therapy
LDL Cholesterol
Time frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)
Time frame: 12 weeks post periodontal therapy
Intercellular Adhesion Molecule 1 (ICAM-1)
Time frame: 12 weeks post periodontal therapy
Vascular Cell Adhesion Molecule 1 (VCAM-1)
Time frame: 12 weeks post periodontal therapy
Myeloperoxidase (MPO)
Time frame: 12 weeks post periodontal therapy
Matrix Metalloproteinase-9 (MMP-9)
Time frame: 12 weeks post periodontal therapy
Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)
Time frame: 12 weeks post periodontal therapy

Results and safety

Results posted to the registry on 1 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Periodontal Intervention (Experimental)	47	41
Periodontal Prophylaxis (Active Comparator)	55	47

Primary outcome: Brachial Artery Flow-mediated Dilation

Time frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy. Mean (Standard Deviation). Unit: Percentage of dilatation of brachial art

Measure	Periodontal Intervention (Experimental) n = 41	Periodontal Prophylaxis (Active Comparator) n = 46
Baseline	10.2 (7.3)	10.3 (8.7)
24 hours	13.1 (9.5)	8.1 (7.8)
12 weeks	11.2 (9.7)	9.7 (8.5)

Periodontal Intervention (Experimental) vs Periodontal Prophylaxis (Active Comparator): p = 0.98, Kruskal-Wallis
Periodontal Intervention (Experimental) vs Periodontal Prophylaxis (Active Comparator): p = 0.005, Kruskal-Wallis
Periodontal Intervention (Experimental) vs Periodontal Prophylaxis (Active Comparator): p = 0.43, Kruskal-Wallis

Population analysed: The primary outcome (difference on endothelium-dependent brachial artery FMD at baseline and three months after randomization) and the secondary outcome (hs-CRP, glucose, blood lipid profile and cardiovascular biomarkers) were analyzed using kruskal-wallis and unpaired t test depending on the distribution of the variables.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: One day after periodontal therapy. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Periodontal Intervention (Experimental)	0 of 47 (0%)	47 of 47 (100%)	Not reported
Periodontal Prophylaxis (Active Comparator)	1 of 55 (1.8%)	31 of 55 (56.4%)	Not reported

Limitations and caveats (from the sponsor): 1\. Patient recruitment take more time that previously expected, 2. Longer time than expected for the standardization for laboratory techniques, 3. Changes of the study personnel during patient recruitment and laboratory analysis of biological samples

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24495202Ramirez JH, Parra B, Gutierrez S, Arce RM, Jaramillo A, Ariza Y, Contreras A. Biomarkers of cardiovascular disease are increased in untreated chronic periodontitis: a case control study. Aust Dent J. 2014 Mar;59(1):29-36. doi: 10.1111/adj.12139. Epub 2014 Feb 4.
Derived from this study: PubMed 21324167Ramirez JH, Arce RM, Contreras A. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. Trials. 2011 Feb 16;12:46. doi: 10.1186/1745-6215-12-46.

Related trials for Periodontitis

Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis: A Pilot Prospective Longitudinal Observational Cohort Study
Periodontitis (Stage 3), Periodontitis Stage IV
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
Active, not recruitingObservational study
Evaluation of MTHFR and DNMT3B Gene Polymorphisms Along With Periodontal Clinical Parameters in Healthy Individuals and Individuals With Type 2 Diabetes and Periodontitis
Periodontitis, Type 2 Diabetes Mellitus (DM)

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.

Adolfo Contreras, DDS, MS, PhD principal investigator

Universidad del Valle

Jorge H Ramirez, MD, MS principal investigator

Universidad del Valle

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing One-Stage Full-Mouth Disinfection and Periodontal care in people with Periodontitis, run by Universidad del Valle, Colombia at 2 sites in Colombia.

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 4 inclusion and 8 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 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Colombia. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Brachial Artery Flow-mediated Dilation (time frame: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00681564, which also lists 2 linked publications.

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 17 Apr 2014.