Periodontal DiseaseNCT01046435
Effects of Periodontal Therapy on Systemic Inflammation
A study testing metronidazole and amoxicillin in people with Periodontal Disease and Cardiovascular Disease, run by University of Chile at 1 site in Chile.
Trial summary
The purpose of this study is to determine if treating periodontal infections (gum disease) will reduce markers of systemic inflammation in patients at risk of cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Periodontal Disease, Cardiovascular Disease, Type 2 Diabetes
- What is being tested?
- metronidazole and amoxicillin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteChile
- Study dates
- Mar 2007to Mar 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosis of marginal periodontitis
- No history of periodontal treatment
- At least 14 natural teeth present
- Dyslipidemia
- And at least one of the following factors:
- obesity
- diabetes
- smoking, hypertension
Who cannot join
- Rheumatoid arthritis
- Any type of cancer in the previous 2 years
- Pregnancy and lactation
- Indication of the use of antibiotic for invasive procedures
- Use of antibiotics in previous three months.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service
Santiago, Santiago Metropolitan
About this study
Official title: Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk
The purpose of this study is to determine if treating periodontal infections (gum disease) will reduce markers of systemic inflammation in patients at risk of cardiovascular diseases.
Read the detailed description
Aims: To determine the effects of periodontal treatment on systemic markers of inflammation in subjects with risk of coronary heart disease.
Methods: The current study is a randomized, double blind clinical trial, with two treatment groups.
Eligible participants will be allocated by restricted randomization using the minimization method to the treatment group or to the control group. The treatment group will receive periodontal therapy consisting of instructions of plaque control, supra and subgingival scaling and root planing, oral systemic metronidazole (250 mg) plus amoxicillin (500 mg) tid for 7 days. The control group will receive plaque control instructions, supragingival scaling and two placebos. The study plan to enroll 160 participants, 80 in ech arm, over a 6-month period. Follow-up clinic visits will be scheduled to occur every 3 months after finishing treatment. Baseline and follow-up clinic visits will include periodontal examination, blood collection and medical and dental histories. The following biochemical markers will be determined at baseline and at 3, 6, 9 and 12 months posttherapy: total, LDL and HDL lipoprotein cholesterol and triglycerides, glycemia, high sensitivity C-reactive protein, fibrinogen, erythrocyte sedimentation rate and white blood cells count. In diabetic patients, glycosylated hemoglobin will be also assessed.
The study will be conducted in a public health center in Santiago, Chile. To be eligible for the study, participants have to be older than 35 years and fulfill the medical and periodontal criteria. For the medical criteria participants have to have dyslipidemia, and at least one of the following coronary heart disease risk factors: obesity, smoking, diabetes, hypertension.
The periodontal inclusion criteria are: no history of periodontal treatment, the presence of at least 14 natural teeth, with at least 4 teeth with interproximal sites with probing depth equal or higher than 4 mm and concomitant attachment loss equal or higher than 3 mm, and >30 % of sites with bleeding on probing.
The outcomes measures will be levels of serum C-reactive protein, fibrinogen, erythrosedimentation rate, white blood cell count.The outcomes will be measured at 0, 3,6,9, and 6 months after periodontal therapy.
- Being tested
- metronidazole and amoxicillin, Two placebos
- Keywords
- periodontitis, cardiovascular disease, diabetes
- Medical subject headings
- Periodontal Diseases, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Obesity, Metabolic Syndrome, Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metronidazole and amoxicillinProcedure or surgery
Also called Non-surgical periodontal therapy
Metronidazole 250 mg three times a day per 7 days
Two placebosProcedure or surgery
Also called Community periodontal treatment
Two placebos 3 times a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Supragingival scaling plus placebo | Placebo comparator | Plaque control instructions, supra gingival scaling and two placebos Receives: Procedure: metronidazole and amoxicillin; Procedure: Two placebos |
| Root planing plus antibiotics | Experimental | Plaque control instructions, subgingival scaling,root planing, metronidazole 250 mg and amoxicillin 500 mg. three times a day for 7 days Receives: Procedure: metronidazole and amoxicillin; Procedure: Two placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count
Measured: 0, 3, 6, 9 and 12 months after therapy
Secondary outcomes (1)
Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level
Measured: 0, 3, 6, 9 and 12 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startMar 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Investigators
- Nestor J. Lopez, DDS, Principal investigator, University of ChileAntonio Quintero, DDS, Principal investigator, University of ChileCarola Ibieta, DDS, Study chair, University of ChileCarlos Y Valenzuela, DMS, PhD, Study chair, University of ChileLilian Jara, MsB, PhD, Study chair, University of ChileMarcelo Llancaqueo, DMS, Study chair, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046435
- Sponsor's protocol ID
- FONDECYT 1061070
- Status last verified
- May 2006
- First submitted
- 11 Jan 2010
- Last updated
- 25 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT01046435
- Acronym / sponsor ID
- FONDECYT 1061070
- Keywords
- periodontitis, cardiovascular disease, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Jan 2010 (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 purpose of this study is to determine if treating periodontal infections (gum disease) will reduce markers of systemic inflammation in patients at risk of cardiovascular diseases.
Detailed description
Aims: To determine the effects of periodontal treatment on systemic markers of inflammation in subjects with risk of coronary heart disease.
Methods: The current study is a randomized, double blind clinical trial, with two treatment groups.
Eligible participants will be allocated by restricted randomization using the minimization method to the treatment group or to the control group. The treatment group will receive periodontal therapy consisting of instructions of plaque control, supra and subgingival scaling and root planing, oral systemic metronidazole (250 mg) plus amoxicillin (500 mg) tid for 7 days. The control group will receive plaque control instructions, supragingival scaling and two placebos. The study plan to enroll 160 participants, 80 in ech arm, over a 6-month period. Follow-up clinic visits will be scheduled to occur every 3 months after finishing treatment. Baseline and follow-up clinic visits will include periodontal examination, blood collection and medical and dental histories. The following biochemical markers will be determined at baseline and at 3, 6, 9 and 12 months posttherapy: total, LDL and HDL lipoprotein cholesterol and triglycerides, glycemia, high sensitivity C-reactive protein, fibrinogen, erythrocyte sedimentation rate and white blood cells count. In diabetic patients, glycosylated hemoglobin will be also assessed.
The study will be conducted in a public health center in Santiago, Chile. To be eligible for the study, participants have to be older than 35 years and fulfill the medical and periodontal criteria. For the medical criteria participants have to have dyslipidemia, and at least one of the following coronary heart disease risk factors: obesity, smoking, diabetes, hypertension.
The periodontal inclusion criteria are: no history of periodontal treatment, the presence of at least 14 natural teeth, with at least 4 teeth with interproximal sites with probing depth equal or higher than 4 mm and concomitant attachment loss equal or higher than 3 mm, and >30 % of sites with bleeding on probing.
The outcomes measures will be levels of serum C-reactive protein, fibrinogen, erythrosedimentation rate, white blood cell count.The outcomes will be measured at 0, 3,6,9, and 6 months after periodontal therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supragingival scaling plus placebo | Placebo comparator | Procedure: metronidazole and amoxicillin, Procedure: Two placebosPlaque control instructions, supra gingival scaling and two placebos |
| Root planing plus antibiotics | Experimental | Procedure: metronidazole and amoxicillin, Procedure: Two placebosPlaque control instructions, subgingival scaling,root planing, metronidazole 250 mg and amoxicillin 500 mg. three times a day for 7 days |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinically diagnosis of marginal periodontitis
- No history of periodontal treatment
- At least 14 natural teeth present
- Dyslipidemia
- And at least one of the following factors:
Key exclusion criteria (5 listed)
- Rheumatoid arthritis
- Any type of cancer in the previous 2 years
- Pregnancy and lactation
- Indication of the use of antibiotic for invasive procedures
- Use of antibiotics in previous three months.
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 |
|---|---|---|
| metronidazole and amoxicillinAlso: Non-surgical periodontal therapyMetronidazole 250 mg three times a day per 7 days | Procedure or surgery | Root planing plus antibiotics, Supragingival scaling plus placebo |
| Two placebosAlso: Community periodontal treatmentTwo placebos 3 times a day for 7 days | Procedure or surgery | Root planing plus antibiotics, Supragingival scaling plus placebo |
Primary outcome
Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count
Time frame: 0, 3, 6, 9 and 12 months after therapy
1 secondary outcome
Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level
Time frame: 0, 3, 6, 9 and 12 months after therapy
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 25 Mar 2010.
- Related InfoLink provided by the sponsor.
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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.
Nestor J. Lopez, DDS principal investigator
University of Chile
Antonio Quintero, DDS principal investigator
University of Chile
Carola Ibieta, DDS study chair
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metronidazole and amoxicillin in people with Periodontal Disease and Cardiovascular Disease, run by University of Chile at 1 site in Chile.
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 8 inclusion and 5 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 25 Mar 2010. 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 Chile. 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. Some participants in this study may receive a placebo. 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?
Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count (time frame: 0, 3, 6, 9 and 12 months after therapy). 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 25 Mar 2010.