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Completed

NCT Number: NCT03960216

Effects of Periodontal Therapy 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.

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Key information

Conditions

Periodontitis Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Stomatognathic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scaling and root planning

Procedure

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 Prophylaxis

Procedure

Supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Colgate Palmolive

Registry information

Official study title

Effects of Periodontal Therapy on Local and Systemic Markers of Inflammation in Patients With Metabolic Syndrome

Acronym: MetS

Important dates

Study start
2012
Primary completion
2013
Study completion
2018
First posted
May 23, 2019
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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