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Effects of Periodontal Therapy in Patients With Metabolic Syndrome (MetS)

Primary Purpose

Periodontitis, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scaling and root planning
Supragingival Prophylaxis
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Minimal Periodontal Treatment (MPT)

    Intensive Periodontal Treatment (IPT)

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    Change in C-reactive protein
    Main outcome variable is the change in concentration of C-reactive protein between baseline and 6 months

    Secondary Outcome Measures

    Change in Probing Pocket Depth
    Examination of probing pocket depth will be determined with a periodontal probe and expressed in mm
    Change in Clinical Attachment Level
    Examination of clinical attachment level will be determined with a periodontal probe and expressed in mm
    Change in Plaque Index
    Examination of plaque index
    Change in Bleeding on Probing
    Examination of bleeding on probing
    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
    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
    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
    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
    Change in the % of Glycated haemoglobin
    Analysis of glycated haemoglobin was determined in the Lab of the University Hospital

    Full Information

    First Posted
    May 16, 2019
    Last Updated
    May 23, 2019
    Sponsor
    Universidad Complutense de Madrid
    Collaborators
    Colgate Palmolive
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03960216
    Brief Title
    Effects of Periodontal Therapy in Patients With Metabolic Syndrome
    Acronym
    MetS
    Official Title
    Effects of Periodontal Therapy on Local and Systemic Markers of Inflammation in Patients With Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 28, 2012 (Actual)
    Primary Completion Date
    May 30, 2013 (Actual)
    Study Completion Date
    July 2, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidad Complutense de Madrid
    Collaborators
    Colgate Palmolive

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Metabolic Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Minimal Periodontal Treatment (MPT)
    Arm Type
    Sham Comparator
    Arm Description
    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).
    Arm Title
    Intensive Periodontal Treatment (IPT)
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Scaling and root planning
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Supragingival Prophylaxis
    Intervention Description
    Supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart.
    Primary Outcome Measure Information:
    Title
    Change in C-reactive protein
    Description
    Main outcome variable is the change in concentration of C-reactive protein between baseline and 6 months
    Time Frame
    Baseline, 3 months and 6 months
    Secondary Outcome Measure Information:
    Title
    Change in Probing Pocket Depth
    Description
    Examination of probing pocket depth will be determined with a periodontal probe and expressed in mm
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change in Clinical Attachment Level
    Description
    Examination of clinical attachment level will be determined with a periodontal probe and expressed in mm
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change in Plaque Index
    Description
    Examination of plaque index
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change in Bleeding on Probing
    Description
    Examination of bleeding on probing
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change in the presence of selected periodontal pathogens
    Description
    Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change in the total counts of selected periodontal pathogens
    Description
    By means of anaerobic culture. Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change in the proportions of selected periodontal pathogens
    Description
    Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change in the concentration of Inflammatory mediators (IL-1β, IL-6, IL-8 and TNF-α) in plasma and gingival crevicular fluid
    Description
    The inflammatory mediators will be determined by Luminex
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change in the % of Glycated haemoglobin
    Description
    Analysis of glycated haemoglobin was determined in the Lab of the University Hospital
    Time Frame
    Baseline, 3 months and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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). Exclusion Criteria: 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. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mariano Sanz
    Organizational Affiliation
    University Complutense of Madrid
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Periodontal Therapy in Patients With Metabolic Syndrome

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