Impact of Periodontal Treatment on Serum Levels of Hepcidin and Hemoglobin

NCT02641210 | Completed Phase 4 DMC

• 1 other identifier: 23115-010215/2011-16
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

Periodontitis is an inflammatory/infectious disease of high prevalence in the population and which has been linked to several chronic inflammatory systemic diseases. However, few studies have evaluated the periodontal disease in the absence of other inflammatory conditions stimulate inflammatory markers as C-reactive protein (CRP), Interleukin - 6 (IL-6) hepcidin and hemoglobin. The aim of this study was to evaluate the influence of nonsurgical periodontal therapy on the change of inflammatory markers and anemia in control subjects and patients with chronic periodontitis after three months.This interventional study included 67 individuals of both sexes, aged 30-65 years, without other diseases, except chronic periodontitis, with at least 20 teeth, selected from a total 125 individuals following the eligibility criteria. Periodontal clinical parameters (probing depth, bleeding on probing, clinical attachment level) and systemic, hematological as well as inflammatory markers CRP, IL-6 and hepcidin were compared before and after nonsurgical periodontal therapy by serum and plasma examination of control individuals and patients with chronic periodontitis.

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitis; Hepcidin; Hemoglobin; Inflammation

Outcome Measures

Primary Outcomes (1)

• Changes in Hepcidin serum level after periodontal treatment as assessed by ELISA.

  90 days

Secondary Outcomes (4)

• Changes in periodontal outcomes (Probing depth in millimeters and clinical attachment level in millimeter) after periodontal treatment.

  90 days

• Percentage of sites with visible plaque and /or bleeding on probing after periodontal treatment.

  90 days

• Changes in us-CRP serum level after periodontal treatment as assessed by ELISA.

  90 days

• Changes in Interleukin 6 serum level after periodontal treatment as assessed by ELISA.

  90 days

Other Outcomes (1)

• Changes in iron stores (Serum iron, ferritin and transferrin) after periodontal treatment.

  90 days

Study Arms (2)

Periodontal Treatment

EXPERIMENTAL

The experimental group underwent nonsurgical periodontal therapy, performed by a single professional who performed the scaling and root planing procedures under local anesthesia using an ultrasonic device and Gracey and mini Gracey curettes, with Robson polishing brush and prophylactic paste. This therapy was performed in two sessions at seven day intervals, with no time limit, according to the needs of each periodontal condition. In each session, subjects received oral hygiene instruction (OHI) for use of toothbrushes for the modified Bass technique, dental floss and other complementary means (interdental brush, single tuft brush, electric toothbrush, etc.) when necessary. Supportive periodontal therapy was performed in 30, 60 and 90 days. Albendazole administration.

Procedure: Periodontal Treatment; Drug: Albendazole

No Periodontal Treatment

NO INTERVENTION

Individuals in the control group underwent only the polishing of tooth surfaces with Robson brush and prophylactic paste fine-grained and topical fluoride application. After 90 days, they were reassessed with the same parameters of clinical examination of the baseline.

Interventions

Periodontal Treatment PROCEDURE

Periodontal Treatment using Gracey curettes and ultrasonic device.

Also known as: Non-surgical Periodontal Therapy

Periodontal Treatment

Albendazole DRUG

All participants took Albendazole 400 mg before the intervention.

Also known as: drug administration

Periodontal Treatment

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sexes
• Aged 30-65 years
• Without other chronic systemic diseases except periodontitis
• At least 20 teeth

You may not qualify if:

• Diabetes mellitus
• Congestive heart failure
• Chronic kidney disease
• Malignant neoplasms
• Acquired immunodeficiency syndrome
• Hypertension
• Pregnant women
• Nursing mothers
• Immunosuppressed by medication
• Women with changes in menstrual flow
• Smokers or ex-smokers for less than 10 years
• Usage history of NSAIDs or nonsteroidal and antibiotics within 3 months prior to the study and during the search
• Iron replacement in patients to treat anemia and carrying out subgingival scaling and periodontal surgery in 6 months prior to investigation.

Sponsors & Collaborators

• Federal University of Maranhao: lead

MeSH Terms

Conditions

Chronic Periodontitis; Inflammation

Interventions

Periodontal Index; Albendazole

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Federal University of Maranhao

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: December 29, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12