PeriodontitisMetSNCT03960216
Effects of Periodontal Therapy in Patients With Metabolic Syndrome
A study testing Scaling and root planning and Supragingival Prophylaxis in people with Periodontitis and Metabolic Syndrome, run by Universidad Complutense de Madrid.
Trial summary
A 6-month, parallel-arm, investigator-masked, randomized clinical trial was conducted in patients with MetS and severe periodontitis. Participants were randomly assigned to an Intensive Periodontal Treatment group (IPT; scaling and root planing and azithromycin capsules 500mg/24h/3days) or to a Minimal Periodontal… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Periodontitis, Metabolic Syndrome
- What is being tested?
- Scaling and root planning and Supragingival Prophylaxis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2012to 2 Jul 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Metabolic Syndrome according to the IDF definition
- at least 16 teeth
- at least eight sites with probing pocket depth (PPD) ≥ 6 mm and four sites with clinical attachment loss ≥ 5 mm, distributed in at least two different quadrants (Koromantzos et al. 2012).
Who cannot join
- They are not medically controlled for obesity and cardiovascular risk factors at the start of the study. For ethical reasons, patient inclusion must be delayed at least 3 months when begins a pharmacological treatment.
- They had history of kidney disease with Cr>1.2, CKD-EPI< 70 mil/min, or proteinuria > 300 mg/24 hours or 0.3 mg/grCr in isolated sample.
- They had history of chronic lung disease, or acute disease during the previous 3 months.
- They had history of stroke during the previous 3 months, myocardial infarction or revascularization during the previous 6 months, or recent angor pectoris history.
- They had history of known peripheral artery disease, or chronic heart failure.
- They had surgical treatment during the previous 3 months.
Show all 9Show fewer
- They had any disease that conditions compliance along the study, such as alcoholism or psychiatric disorder.
- They had a history of systemic antibiotic usage over the previous 3 months.
- They had non-surgical periodontal treatment during the previous 6 months; or surgical periodontal treatment over the previous 12 months.
About this study
Official title: Effects of Periodontal Therapy on Local and Systemic Markers of Inflammation in Patients With Metabolic Syndrome
A 6-month, parallel-arm, investigator-masked, randomized clinical trial was conducted in patients with MetS and severe periodontitis. Participants were randomly assigned to an Intensive Periodontal Treatment group (IPT; scaling and root planing and azithromycin capsules 500mg/24h/3days) or to a Minimal Periodontal Treatment group (MPT; professional plaque removal and placebo capsules). Blood and subgingival microbiological samples were collected at baseline, 3 and 6 months after therapy. The primary outcome was between-group difference in C-reactive protein (CRP). Secondary outcomes included HbA1c, lipids, α-1 antitrypsin, fibrinogen levels and subgingival microbiota assessment.
- Conditions
- Periodontitis, Metabolic Syndrome
- Being tested
- Scaling and root planning, Supragingival Prophylaxis
- Medical subject headings
- Periodontitis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planningProcedure or surgery
Patients received non-surgical periodontal therapy in the form of full-mouth scaling and root planing (SRP), in two sessions, 1 week apart, with the use of an ultrasonic scaler (Minipiezon Electromedical Systems EMS, Nyon, Switzerland) and hand instruments, under local anaesthesia.
Supragingival ProphylaxisProcedure or surgery
Supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Periodontal Treatment (MPT) | Sham comparator | Once the hopeless teeth have been extracted, randomized patients will receive a periodontal prophylaxis, in the form of supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart. During this week the patients will be prescribed local antiseptics (chlorhexidine rinse, 2x, 10 days) and, after the last session, placebo capsules (one every 24 h for three days). Receives: Procedure: Supragingival Prophylaxis |
| Intensive Periodontal Treatment (IPT) | Experimental | Once the hopeless teeth have been extracted, randomized patients will receive non-surgical periodontal therapy in the form of full-mouth scaling and root planing (SRP), in two sessions, 1 week apart, with the use of an ultrasonic scaler (Minipiezon Electromedical Systems EMS, Nyon, Switzerland) and hand instruments, under local anaesthesia. During this week the patients will be prescribed local antiseptics (chlorhexidine rinse, 2x, 10 days) and after the last session, systemic antibiotics (azithromycin 500 mgrs, every 24 h for three days). Receives: Procedure: Scaling and root planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in C-reactive protein
Main outcome variable is the change in concentration of C-reactive protein between baseline and 6 months
Measured: Baseline, 3 months and 6 months
Secondary outcomes (9)
Change in Probing Pocket Depth
Examination of probing pocket depth will be determined with a periodontal probe and expressed in mm
Measured: Baseline, 3 months and 6 months
Change in Clinical Attachment Level
Examination of clinical attachment level will be determined with a periodontal probe and expressed in mm
Measured: Baseline, 3 months and 6 months
Change in Plaque Index
Examination of plaque index
Measured: Baseline, 3 months and 6 months
Change in Bleeding on Probing
Examination of bleeding on probing
Measured: Baseline, 3 months and 6 months
Change in the presence of selected periodontal pathogens
Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum
Measured: Baseline, 3 months and 6 months
Change in the total counts of selected periodontal pathogens
By means of anaerobic culture. Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum
Measured: Baseline, 3 months and 6 months
Change in the proportions of selected periodontal pathogens
Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum
Measured: Baseline, 3 months and 6 months
Change in the concentration of Inflammatory mediators (IL-1β, IL-6, IL-8 and TNF-α) in plasma and gingival crevicular fluid
The inflammatory mediators will be determined by Luminex
Measured: Baseline, 3 months and 6 months
Change in the % of Glycated haemoglobin
Analysis of glycated haemoglobin was determined in the Lab of the University Hospital
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start28 Nov 2012
- Primary completion30 May 2013
- Study completion2 Jul 2018
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.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Sponsor
- Investigators
- Mariano Sanz, Principal investigator, University Complutense of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960216
- Sponsor's protocol ID
- 12/206 CEIC Hospital Clínico
- Acronym
- MetS
- Status last verified
- May 2019
- First submitted
- 16 May 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Periodontal Therapy on Local and Systemic Markers of Inflammation in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03960216
- Acronym / sponsor ID
- MetS / 12/206 CEIC Hospital Clínico
- Conditions
- Periodontitis, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- 28 Nov 2012 (actual)
- Primary completion
- 30 May 2013 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 23 May 2019 (actual)
- 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.
A 6-month, parallel-arm, investigator-masked, randomized clinical trial was conducted in patients with MetS and severe periodontitis. Participants were randomly assigned to an Intensive Periodontal Treatment group (IPT; scaling and root planing and azithromycin capsules 500mg/24h/3days) or to a Minimal Periodontal Treatment group (MPT; professional plaque removal and placebo capsules). Blood and subgingival microbiological samples were collected at baseline, 3 and 6 months after therapy. The primary outcome was between-group difference in C-reactive protein (CRP). Secondary outcomes included HbA1c, lipids, α-1 antitrypsin, fibrinogen levels and subgingival microbiota assessment.
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 |
|---|---|---|
| Minimal Periodontal Treatment (MPT) | Sham comparator | Procedure: Supragingival ProphylaxisOnce the hopeless teeth have been extracted, randomized patients will receive a periodontal prophylaxis, in the form of supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart. During this week the patients will be prescribed local antiseptics (chlorhexidine rinse, 2x, 10 days) and, after the last session, placebo capsules (one every 24 h for three days). |
| Intensive Periodontal Treatment (IPT) | Experimental | Procedure: Scaling and root planningOnce the hopeless teeth have been extracted, randomized patients will receive non-surgical periodontal therapy in the form of full-mouth scaling and root planing (SRP), in two sessions, 1 week apart, with the use of an ultrasonic scaler (Minipiezon Electromedical Systems EMS, Nyon, Switzerland) and hand instruments, under local anaesthesia. During this week the patients will be prescribed local antiseptics (chlorhexidine rinse, 2x, 10 days) and after the last session, systemic antibiotics (azithromycin 500 mgrs, every 24 h for three days). |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Metabolic Syndrome according to the IDF definition
- at least 16 teeth
- at least eight sites with probing pocket depth (PPD) ≥ 6 mm and four sites with clinical attachment loss ≥ 5 mm, distributed in at least two different quadrants (Koromantzos et al. 2012).
Key exclusion criteria (9 listed)
- They are not medically controlled for obesity and cardiovascular risk factors at the start of the study. For ethical reasons, patient inclusion must be delayed at least 3 months when begins a pharmacological treatment.
- They had history of kidney disease with Cr>1.2, CKD-EPI< 70 mil/min, or proteinuria > 300 mg/24 hours or 0.3 mg/grCr in isolated sample.
- They had history of chronic lung disease, or acute disease during the previous 3 months.
- They had history of stroke during the previous 3 months, myocardial infarction or revascularization during the previous 6 months, or recent angor pectoris history.
- They had history of known peripheral artery disease, or chronic heart failure.
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 |
|---|---|---|
| Scaling and root planningPatients received non-surgical periodontal therapy in the form of full-mouth scaling and root planing (SRP), in two sessions, 1 week apart, with the use of an ultrasonic scaler (Minipiezon Electromedical Systems EMS, Nyon, Switzerland) and hand instruments, under local anaesthesia. | Procedure or surgery | Intensive Periodontal Treatment (IPT) |
| Supragingival ProphylaxisSupragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart. | Procedure or surgery | Minimal Periodontal Treatment (MPT) |
Primary outcome
Change in C-reactive protein
Time frame: Baseline, 3 months and 6 months
Main outcome variable is the change in concentration of C-reactive protein between baseline and 6 months
9 secondary outcomes
Change in Probing Pocket Depth
Time frame: Baseline, 3 months and 6 months
Change in Clinical Attachment Level
Time frame: Baseline, 3 months and 6 months
Change in Plaque Index
Time frame: Baseline, 3 months and 6 months
Change in Bleeding on Probing
Time frame: Baseline, 3 months and 6 months
Change in the presence of selected periodontal pathogens
Time frame: Baseline, 3 months and 6 months
Change in the total counts of selected periodontal pathogens
Time frame: Baseline, 3 months and 6 months
Change in the proportions of selected periodontal pathogens
Time frame: Baseline, 3 months and 6 months
Change in the concentration of Inflammatory mediators (IL-1β, IL-6, IL-8 and TNF-α) in plasma and gingival crevicular fluid
Time frame: Baseline, 3 months and 6 months
Change in the % of Glycated haemoglobin
Time frame: Baseline, 3 months and 6 months
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 28 May 2019.
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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.
Mariano Sanz principal investigator
University Complutense of Madrid
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planning and Supragingival Prophylaxis in people with Periodontitis and Metabolic Syndrome, run by Universidad Complutense de Madrid.
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 9 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 28 May 2019. 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. 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?
Change in C-reactive protein (time frame: Baseline, 3 months and 6 months). 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 28 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.