Serum A.Actinomycetemcomitans Antibodies and Periodontitis

Completed

• Conditions: Periodontal Diseases
• Interventions: Other: observation of serum A.actinomycetemcomitans levels

• Registration Number: NCT04417322
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2016-04-15
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-25
• Status Verified: 2020-06
• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-01
• Last Update Submitted: 2020-06-01
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	observation of serum A.actinomycetemcomitans levels	Observation of serum A.actinomycetemcomitans levels and correlation of plasma A.actinomycetemcomitans levels
Periodontitis	observation of serum A.actinomycetemcomitans levels	Observation of serum A.actinomycetemcomitans levels and correlation of plasma A.actinomycetemcomitans levels

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level	1-year	evaluation of changes in clinical attachment level

Trial Locations

Locations (1)

University of Messina; 🇮🇹 Messina, Italy