NCT04806971

Brief Summary

Background: The aim of the study is to find out the prevelance of VDR (rs731236), IL1B (rs1143634) and IL1A (rs1800587)gene polymorphisms in Turkish population and their association with stage III grade B / C periodontitis. Methods: Individuals who were found to be systemically and periodontally healthy (N = 100) after clinical and radiographic examination and who were diagnosed with Stage III Grade B / C periodontitis (N = 100) were included in the study. Gingival index, Plaque index, bleeding on probing, clinical attachment level and pocket depths of the patients were recorded. subjects genotyped for rs731236, rs1143634 and rs1800587 gene polymorphisms with Real Time Polymerase Chain Reaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

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

January 29, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
Last Updated

December 15, 2021

Status Verified

November 1, 2021

Enrollment Period

1.7 years

First QC Date

March 16, 2021

Last Update Submit

November 30, 2021

Conditions

Keywords

Vitamin D receptorPolymorphismPeriodontitis,Interleukin-1BInterleukin-1A

Outcome Measures

Primary Outcomes (3)

  • IL-1A gene polymorphism

    baseline

  • Interleukin-1B gene polymorphism

    baseline

  • Vitamin D Receptor gene polymorphism

    baseline

Study Arms (2)

Periodontitis

Patients with grade B / C, stage III periodontitis were classified based on the new classification criteria.Clinical attachment loss ≥5 mm, probing depth (PD) ≥6 mm, ≥20 teeth and radiographic bone loss extending to the root middle third. Grade was assessed considering the radiographic bone loss in the most affected tooth in the dentition as a function of age (Grade B=0.25-1.0, Grade C= \>1.0).

Healthy

The periodontally healthy subjects without any clinical sign of inflammation,not showing a history of periodontitis; PD ≤3 mm; \<10% of sites with BOP; an absence of detectable bone loss and/or attachment ; without extensive caries or restorations and presence of at least 28 permanent teeth. In addition, all the control subjects showed the absence of any local or systemic pathology.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

200 subjects were recruited from the Marmara University, Faculty of Dentistry, Clinics of Periodontology

You may qualify if:

  • systemically healthy, previously untreated periodontitis patients

You may not qualify if:

  • presence of systemic disease such as diabetes, rheumatic fever, liver or kidney diseases, neurologic deficiencies, immunologic diseases; pregnancy; smoking; receive of any medication which may affect periodontal tissues; used antibiotics for any purpose within 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

Marmara University Dental Faculty Periodontology Department

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

March 16, 2021

First Posted

March 19, 2021

Study Start

January 29, 2018

Primary Completion

September 27, 2019

Study Completion

September 27, 2019

Last Updated

December 15, 2021

Record last verified: 2021-11

Locations