NCT06540755

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

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

December 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 2, 2024

Last Update Submit

August 2, 2024

Conditions

PeriodontitisPolymorphism, Restriction Fragment Length

Keywords

PolymorphismPregnancy-Associated Plasma Protein-AInterleukin-6genetic

Outcome Measures

Primary Outcomes (1)

  • The genotypic or allelic distributions of PAPP-A and IL-6 gene polymorphisms

    they were similar between groups

    baseline

Study Arms (2)

H Group

periodontally healthy individuals

Genetic: genetic polymorphism analysis

P Group

stage 3 grade B and C periodontitis patients

Genetic: genetic polymorphism analysis

Interventions

genetic polymorphism analysisGENETIC

Genotype for IL-6 rs1800795 and PAPP-A rs7020782 polymorphisms were determined using real-time polymerase chain reaction with allele-specific probes.

H GroupP Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may not qualify if:

  • The samples taken cannot be stored under appropriate conditions and are damaged.
  • The onset of a systemic disease in a systemically healthy individual.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Dental Faculty Periodontology Departmen

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 6, 2024

Study Start

December 2, 2022

Primary Completion

January 26, 2023

Study Completion

January 28, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Locations

TU(1)