Effects of Periodontal Therapy in Patients With Metabolic Syndrome

NCT03960216 | Completed

• 1 other identifier: 12/206 CEIC Hospital Clínico
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in C-reactive protein

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

  Baseline, 3 months and 6 months

Secondary Outcomes (9)

• Change in Probing Pocket Depth

  Baseline, 3 months and 6 months

• Change in Clinical Attachment Level

  Baseline, 3 months and 6 months

• Change in Plaque Index

  Baseline, 3 months and 6 months

• Change in Bleeding on Probing

  Baseline, 3 months and 6 months

• Change in the presence of selected periodontal pathogens

  Baseline, 3 months and 6 months

Study Arms (2)

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).

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).

Procedure: Scaling and root planning

Interventions

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.

Intensive Periodontal Treatment (IPT)

Supragingival Prophylaxis PROCEDURE

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

Minimal Periodontal Treatment (MPT)

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Colgate Palmolive: collaborator

MeSH Terms

Conditions

Periodontitis; Metabolic Syndrome

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Mariano Sanz

  University Complutense of Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 23, 2019
• Study Start: November 28, 2012
• Primary Completion: May 30, 2013
• Study Completion: July 2, 2018
• Last Updated: May 28, 2019

Record last verified: 2019-05