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NCT04417322 Clinical Trial

Serum A.Actinomycetemcomitans Antibodies and Periodontitis

Periodontal Diseases Clinical Trial

Official title:
Association Among Serum A.Actinomycetemcomitans Antibodies and Periodontitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04417322
Other study ID # 16-18-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2016
Est. completion date March 25, 2020

Study information
Verified date June 2020
Source University of Messina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 221
Est. completion date March 25, 2020
Est. primary completion date March 2, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 34 Years to 72 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• observation of serum A.actinomycetemcomitans levels
Analysis of serum A.actinomycetemcomitans levels

Locations
Country Name City State
Italy University of Messina Messina

Sponsors (1)
Lead Sponsor Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Attachment Level evaluation of changes in clinical attachment level 1-year
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