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Serum A.Actinomycetemcomitans Antibodies and Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417322
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Gaetano Isola, DDS, PhD, University of Messina

Brief Summary:
The aim of this study was to analyze the association between serum A.actinomycetemcomitans antibodies in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced serum IgG A.actinomycetemcomitans antibodies levels

Condition or disease Intervention/treatment
Periodontal Diseases Other: observation of serum A.actinomycetemcomitans levels

Detailed Description:
53 patients with periodontitis and 48 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis and A.actinomycetemcomitans antibodies were expressed and evaluated enzyme-linked immunosorbent assay (ELISA) units (EU). The Spearman Correlation Test and Jonckheere-Terpstra Test were applied in order to assess the interdependence between serum IgG A.actinomycetemcomitans antibodies and clinical periodontal parameters.

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Study Type : Observational
Actual Enrollment : 221 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Association Among Serum A.Actinomycetemcomitans Antibodies and Periodontitis
Actual Study Start Date : April 15, 2016
Actual Primary Completion Date : March 2, 2020
Actual Study Completion Date : March 25, 2020

Group/Cohort Intervention/treatment
Control
Observation of serum A.actinomycetemcomitans levels and correlation of plasma A.actinomycetemcomitans levels
Other: observation of serum A.actinomycetemcomitans levels
Analysis of serum A.actinomycetemcomitans levels

Periodontitis
Observation of serum A.actinomycetemcomitans levels and correlation of plasma A.actinomycetemcomitans levels
Other: observation of serum A.actinomycetemcomitans levels
Analysis of serum A.actinomycetemcomitans levels




Primary Outcome Measures :
  1. Clinical Attachment Level [ Time Frame: 1-year ]
    evaluation of changes in clinical attachment level



Information from the National Library of Medicine

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Ages Eligible for Study:   34 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
53 patients with periodontitis and 48 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis, andA.actinomycetemcomitans antibodies were expressed and evaluated enzyme-linked immunosorbent assay (ELISA) units (EU).
Criteria

Inclusion Criteria:

  • Presence of at least 15 teeth
  • CP with a minimum of 40% of sites with a clinical attachment level (CAL)

    ≥2mm and probing depth (PD) ≥4mm;

  • Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
  • Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

  • Intake of contraceptives
  • Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
  • Status of pregnancy or lactation
  • Previous history of excessive drinking
  • Allergy to local anaesthetic
  • Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417322


Locations
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Italy
University of Messina
Messina, Italy, 98100
Sponsors and Collaborators
University of Messina
Investigators
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Study Chair: Giovanni Matarese University of Messina
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gaetano Isola, DDS, PhD, Researcher, University of Messina
ClinicalTrials.gov Identifier: NCT04417322    
Other Study ID Numbers: 16-18-01
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all collected IPD, all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 1-year
Access Criteria: Official website

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases