Serum A.Actinomycetemcomitans Antibodies and Periodontitis
Association Among Serum A.Actinomycetemcomitans Antibodies and Periodontitis
1 other identifier
observational
221
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2020
CompletedFirst Submitted
Initial submission to the registry
June 1, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedJune 4, 2020
June 1, 2020
3.9 years
June 1, 2020
June 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Attachment Level
evaluation of changes in clinical attachment level
1-year
Study Arms (2)
Control
Observation of serum A.actinomycetemcomitans levels and correlation of plasma A.actinomycetemcomitans levels
Periodontitis
Observation of serum A.actinomycetemcomitans levels and correlation of plasma A.actinomycetemcomitans levels
Interventions
Analysis of serum A.actinomycetemcomitans levels
Eligibility Criteria
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).
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Messina
Messina, 98100, Italy
Related Publications (1)
Isola G, Polizzi A, Patini R, Ferlito S, Alibrandi A, Palazzo G. Association among serum and salivary A. actinomycetemcomitans specific immunoglobulin antibodies and periodontitis. BMC Oral Health. 2020 Oct 15;20(1):283. doi: 10.1186/s12903-020-01258-5.
PMID: 33059645DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giovanni Matarese
University of Messina
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
June 1, 2020
First Posted
June 4, 2020
Study Start
April 15, 2016
Primary Completion
March 2, 2020
Study Completion
March 25, 2020
Last Updated
June 4, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 1-year
- Access Criteria
- Official website
all collected IPD, all IPD that underlie results in a publication