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

• ClinicalTrials.gov Identifier: NCT03960216
• Recruitment Status: Completed
• First Posted: May 23, 2019
• Last Update Posted: May 28, 2019
• Sponsor: Universidad Complutense de Madrid
• Collaborator: Colgate Palmolive
• Information provided by (Responsible Party): Universidad Complutense de Madrid

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

• 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

• 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

• Principal Investigator: Mariano Sanz; University Complutense of Madrid

More Information

• Responsible Party: Universidad Complutense de Madrid
• ClinicalTrials.gov Identifier: NCT03960216
• Other Study ID Numbers: 12/206 CEIC Hospital Clínico
• First Posted: May 23, 2019
• Last Update Posted: May 28, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Periodontitis; Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases