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出境医 / 临床实验 / Effects of Periodontal Therapy in Patients With Metabolic Syndrome (MetS)

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

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.

Condition or disease Intervention/treatment Phase
Periodontitis Metabolic Syndrome Procedure: Scaling and root planning Procedure: Supragingival Prophylaxis Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Periodontal Therapy on Local and Systemic Markers of Inflammation in Patients With Metabolic Syndrome
Actual Study Start Date : November 28, 2012
Actual Primary Completion Date : May 30, 2013
Actual Study Completion Date : July 2, 2018
Arms and Interventions
Arm Intervention/treatment
Sham Comparator: Minimal Periodontal Treatment (MPT)
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).
 Procedure: Supragingival Prophylaxis
Supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart.
Experimental: Intensive Periodontal Treatment (IPT)
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).
 Procedure: Scaling and root planning
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.
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in Probing Pocket Depth [ Time Frame: Baseline, 3 months and 6 months ]
    Examination of probing pocket depth will be determined with a periodontal probe and expressed in mm

  2. Change in Clinical Attachment Level [ Time Frame: Baseline, 3 months and 6 months ]
    Examination of clinical attachment level will be determined with a periodontal probe and expressed in mm

  3. Change in Plaque Index [ Time Frame: Baseline, 3 months and 6 months ]
    Examination of plaque index

  4. Change in Bleeding on Probing [ Time Frame: Baseline, 3 months and 6 months ]
    Examination of bleeding on probing

  5. Change in the presence of selected periodontal pathogens [ Time Frame: Baseline, 3 months and 6 months ]
    Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum

  6. Change in the total counts of selected periodontal pathogens [ Time Frame: Baseline, 3 months and 6 months ]
    By means of anaerobic culture. Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum

  7. Change in the proportions of selected periodontal pathogens [ Time Frame: Baseline, 3 months and 6 months ]
    Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum

  8. 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 ]
    The inflammatory mediators will be determined by Luminex

  9. Change in the % of Glycated haemoglobin [ Time Frame: Baseline, 3 months and 6 months ]
    Analysis of glycated haemoglobin was determined in the Lab of the University Hospital


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Sponsors and Collaborators
Universidad Complutense de Madrid
Colgate Palmolive
Investigators
Layout table for investigator information
Principal Investigator: Mariano Sanz University Complutense of Madrid
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date May 28, 2019
Actual Study Start Date  ICMJE November 28, 2012
Actual Primary Completion Date May 30, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Change in Probing Pocket Depth [ Time Frame: Baseline, 3 months and 6 months ]
    Examination of probing pocket depth will be determined with a periodontal probe and expressed in mm
  • Change in Clinical Attachment Level [ Time Frame: Baseline, 3 months and 6 months ]
    Examination of clinical attachment level will be determined with a periodontal probe and expressed in mm
  • Change in Plaque Index [ Time Frame: Baseline, 3 months and 6 months ]
    Examination of plaque index
  • Change in Bleeding on Probing [ Time Frame: Baseline, 3 months and 6 months ]
    Examination of bleeding on probing
  • Change in the presence of selected periodontal pathogens [ Time Frame: Baseline, 3 months and 6 months ]
    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 [ Time Frame: Baseline, 3 months and 6 months ]
    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 [ Time Frame: Baseline, 3 months and 6 months ]
    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 [ Time Frame: Baseline, 3 months and 6 months ]
    The inflammatory mediators will be determined by Luminex
  • Change in the % of Glycated haemoglobin [ Time Frame: Baseline, 3 months and 6 months ]
    Analysis of glycated haemoglobin was determined in the Lab of the University Hospital
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Change in Probing Pocket Depth [ Time Frame: Baseline, 3 months and 6 months ]
    Examination of probing pocket depth
  • Change in Clinical Attachment Level [ Time Frame: Baseline, 3 months and 6 months ]
    Examination of clinical attachment level
  • Change in Plaque Index [ Time Frame: Baseline, 3 months and 6 months ]
    Examination of plaque index
  • Change in Bleeding on Probing [ Time Frame: Baseline, 3 months and 6 months ]
    Examination of bleeding on probing
  • Change in the presence of selected periodontal pathogens [ Time Frame: Baseline, 3 months and 6 months ]
    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 [ Time Frame: Baseline, 3 months and 6 months ]
    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 [ Time Frame: Baseline, 3 months and 6 months ]
    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 [ Time Frame: Baseline, 3 months and 6 months ]
    The inflammatory mediators will be determined by Luminex
  • Change in the % of Glycated haemoglobin [ Time Frame: Baseline, 3 months and 6 months ]
    Analysis of glycated haemoglobin was determined in the Lab of the University Hospital
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Periodontal Therapy in Patients With Metabolic Syndrome
Official Title  ICMJE Effects of Periodontal Therapy on Local and Systemic Markers of Inflammation in Patients With Metabolic Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Periodontitis
  • Metabolic Syndrome
Intervention  ICMJE
  • Procedure: Scaling and root planning
    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.
  • Procedure: Supragingival Prophylaxis
    Supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart.
Study Arms  ICMJE
  • Sham Comparator: Minimal Periodontal Treatment (MPT)
    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).
    Intervention: Procedure: Supragingival Prophylaxis
  • Experimental: Intensive Periodontal Treatment (IPT)
    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: Procedure: Scaling and root planning
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2019) 		60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2, 2018
Actual Primary Completion Date May 30, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960216
Other Study ID Numbers  ICMJE 12/206 CEIC Hospital Clínico
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universidad Complutense de Madrid
Study Sponsor  ICMJE Universidad Complutense de Madrid
Collaborators  ICMJE Colgate Palmolive
Investigators  ICMJE
Principal Investigator: Mariano Sanz University Complutense of Madrid
PRS Account Universidad Complutense de Madrid
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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