Vitamin D Receptor, Interleukin-1A and Interleukin-1B Gene Polymorphisms in Periodontitis

Sponsor

Marmara University (Other)

Overall Status

Completed

CT.gov ID

NCT04806971

Collaborator

(none)

200

Enrollment

Locations

19.9

Actual Duration (Months)

100

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis Polymorphism, Restriction Fragment Length

Detailed Description

In this study we recruited 200 participants from the Periodontology Clinics. Periodontal clinical parameters such as plaque index, gingival index, probing depth and clinical attachment level were assessed. Genotyping rs731236, rs1800587 and rs1143634 gene polymorphisms was performed by Real Time Polymerase Chain Reaction.Statistical analysis was done by the statistical software package SPSS v16. SNPassoc.

Study Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Association Between Vitamin D Receptor, Interleukin-1A and Interleukin-1B Gene Polymorphisms and Stage III Grade B/C Periodontitis

Actual Study Start Date :

Jan 29, 2018

Actual Primary Completion Date :

Sep 27, 2019

Actual Study Completion Date :

Sep 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

IL-1A gene polymorphism [baseline]
Interleukin-1B gene polymorphism [baseline]
Vitamin D Receptor gene polymorphism [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

systemically healthy, previously untreated periodontitis patients

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marmara University	İstanbul	Maltepe	Turkey	34854
2	Marmara University Dental Faculty Periodontology Department	İstanbul		Turkey

Sponsors and Collaborators

Marmara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marmara University

ClinicalTrials.gov Identifier:

NCT04806971

Other Study ID Numbers:

SAG-K-170118-0002

First Posted:

Mar 19, 2021

Last Update Posted:

Dec 15, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marmara University

Additional relevant MeSH terms:

Periodontitis

Study Results

No Results Posted as of Dec 15, 2021