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Impact of Periodontal Treatment on Serum Levels of Hepcidin and Hemoglobin

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ClinicalTrials.gov Identifier: NCT02641210
Recruitment Status : Completed
First Posted : December 29, 2015
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Sandra Augusta de Moura Leite, Federal University of Maranhao

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Periodontal Treatment Drug: Albendazole Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Periodontal Treatment on Serum Levels of Hepcidin and Hemoglobin: a Clinical Trial
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole

Arm Intervention/treatment
Experimental: Periodontal Treatment
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
Periodontal Treatment using Gracey curettes and ultrasonic device.
Other Name: Non-surgical Periodontal Therapy

Drug: Albendazole
All participants took Albendazole 400 mg before the intervention.
Other Name: drug administration

No Intervention: No Periodontal Treatment
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.



Primary Outcome Measures :
  1. Changes in Hepcidin serum level after periodontal treatment as assessed by ELISA. [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Changes in periodontal outcomes (Probing depth in millimeters and clinical attachment level in millimeter) after periodontal treatment. [ Time Frame: 90 days ]
  2. Percentage of sites with visible plaque and /or bleeding on probing after periodontal treatment. [ Time Frame: 90 days ]
  3. Changes in us-CRP serum level after periodontal treatment as assessed by ELISA. [ Time Frame: 90 days ]
  4. Changes in Interleukin 6 serum level after periodontal treatment as assessed by ELISA. [ Time Frame: 90 days ]

Other Outcome Measures:
  1. Changes in iron stores (Serum iron, ferritin and transferrin) after periodontal treatment. [ Time Frame: 90 days ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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Responsible Party: Sandra Augusta de Moura Leite, Professor in Federal University of Maranhao, Federal University of Maranhao
ClinicalTrials.gov Identifier: NCT02641210     History of Changes
Other Study ID Numbers: 23115-010215/2011-16
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015

Keywords provided by Sandra Augusta de Moura Leite, Federal University of Maranhao:
Chronic periodontitis
Hepcidin
Hemoglobin
Inflammation

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Albendazole
Hepcidins
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents