Analysis of Pregnancy-Associated Plasma Protein-A and Interleukin-6 Gene Polymorphisms in Patients With Periodontitis

August 2, 2024 updated by: Marmara University
The aim of this study is to evaluate the relationship between pregnancy associated plasma protein-A (PAPP-A) and interleukin-6 (IL-6) gene polymorphisms and stage 3 grade B and C (S3GBC) periodontitis, and to compare periodontitis patients with healthy individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 226 systemically healthy subjects, consisted of 112 S3GBC periodontitis patients (P group) and 114 periodontally healthy individuals (H group) were included in our study. Clinical and demographic data were recorded. Genomic deoxyribonucleic acid (DNA) molecules were obtained from peripheral blood. Genotype for IL-6 rs1800795 and PAPP-A rs7020782 polymorphisms were determined using real-time polymerase chain reaction with allele-specific probes. The genotypic or allelic distributions of PAPP-A and IL-6 gene polymorphisms were similar between groups (p>0.05). Our finding suggests that there is no relationship between PAPP-A and IL-6 gene polymorphismS and S3GBC periodontitis, furthermore no difference was detected between periodontitis patients and healthy individuals regarding this gene polymorphism.

Study Type

Observational

Enrollment (Actual)

226

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

  • Turkey
      • İstanbul, Turkey
        • Marmara University Dental Faculty Periodontology Departmen

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Group H: The periodontally healthy individuals had an absence of detectable bone and attachment loss, less than 10% of sites with bleeding on probing, and probing depths of ≤3 mm.

Group P: Stage III grade B or grade C periodontitis patients were diagnosed on the base of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions

Description

Inclusion Criteria:

Participants were eligible for inclusion if they were; systemically healthy non-smokers had not undergone periodontal treatment in the past 6 months had not used antibiotics or anti-inflammatory drugs in the preceding 3 months had not used any medication that could affect periodontal tissues in the past 6 months were 18 years of age or older were not pregnant, and were not lactating.

Exclusion Criteria:

The samples taken cannot be stored under appropriate conditions and are damaged.

The onset of a systemic disease in a systemically healthy individual.

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
H Group
periodontally healthy individuals
Genetic: genetic polymorphism analysis
Genotype for IL-6 rs1800795 and PAPP-A rs7020782 polymorphisms were determined using real-time polymerase chain reaction with allele-specific probes.
P Group
stage 3 grade B and C periodontitis patients
Genetic: genetic polymorphism analysis
Genotype for IL-6 rs1800795 and PAPP-A rs7020782 polymorphisms were determined using real-time polymerase chain reaction with allele-specific probes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The genotypic or allelic distributions of PAPP-A and IL-6 gene polymorphisms
Time Frame: baseline
they were similar between groups
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

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)

December 2, 2022

Primary Completion (Actual)

January 26, 2023

Study Completion (Actual)

January 28, 2024

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2022.1611
  • TDH-2023-10969 (Other Identifier: Marmara University Scientific Research Projects Unit (BAPSİS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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