- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04417322
Serum A.Actinomycetemcomitans Antibodies and Periodontitis
June 1, 2020 updated by: Gaetano Isola, DDS, PhD, University of Messina
Association Among Serum A.Actinomycetemcomitans Antibodies and Periodontitis
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
221
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Messina, Italy, 98100
- University of Messina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
34 years to 72 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
Observation of serum A.actinomycetemcomitans levels and correlation of plasma A.actinomycetemcomitans levels
|
Analysis of serum A.actinomycetemcomitans levels
|
Periodontitis
Observation of serum A.actinomycetemcomitans levels and correlation of plasma A.actinomycetemcomitans levels
|
Analysis of serum A.actinomycetemcomitans levels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Attachment Level
Time Frame: 1-year
|
evaluation of changes in clinical attachment level
|
1-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2016
Primary Completion (Actual)
March 2, 2020
Study Completion (Actual)
March 25, 2020
Study Registration Dates
First Submitted
June 1, 2020
First Submitted That Met QC Criteria
June 1, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
June 4, 2020
Last Update Submitted That Met QC Criteria
June 1, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-18-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
all collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
1-year
IPD Sharing Access Criteria
Official website
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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