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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05724251
Other study ID # 9375
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 30, 2021
Est. completion date November 30, 2022

Study information

Verified date February 2023
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to compare urine iodine levels of participants with/without periodontitis. The main question it aims to answer is there a relationship between iodine levels of urine and periodontitis. Participants will give urine samples without any intervention.


Description:

Periodontitis is a chronic, inflammatory disease with a cyclical course with active and passive periods, which may result in the destruction of gingival fibers, resorption of alveolar bone, and subsequent tooth loss, by spreading the inflammatory event that started in the gingiva to the tissues supporting the tooth as a result of the effects of bacteria. The disease is closely associated with many systemic conditions. These conditions include diabetes, cardiovascular diseases, respiratory diseases, birth complications, pregnancy, puberty. Iodine deficiency is an important public health problem by affecting 10-15% of the population due to the diseases it causes. Iodine deficiency affects individuals of all ages. When the daily iodine requirement cannot be met, a group of mental, physical and developmental retardation symptoms called "Iodine deficiency disorders" (IEB) (Iodine deficiency disorders-IDD) occur. With the obligatory iodization of table salt, which started in 1998 in order to eliminate iodine deficiency in Turkey, this problem has been tried to be combated by switching to iodized salt consumption. The study material was used by 73 adult individuals who applied to Atatürk University Faculty of Dentistry, Department of Periodontology for different reasons {1. group (H): periodontally healthy individuals, group 2 (P): individuals with periodontitis}. Urine samples will be collected from the participants without any periodontal intervention. Iodine levels in the urine will be studied. There are studies in the literature to determine iodine deficiency and to determine the population periodontal disease status; however, there are no studies evaluating the possible relationship between iodine deficiency and periodontitis. The aim of this study; To evaluate the iodine levels detected in the urine samples of patients with periodontitis by comparing them with healthy controls, and to investigate the possible role of iodine deficiency in the pathogenesis of periodontitis or a simple marker of disease activity in the light of these findings.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date November 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Individuals should not have any systemic disease that may or may not require medication, including salivary gland pathologies, and not particularly thyroid organ pathologies. - Individuals have not been continuously treated with anti-inflammatory, antioxidant or similar drugs in the last 6 months, - Individuals have not received periodontal treatment until 6 months ago, - Individuals must have at least 14 teeth - Patients diagnosed with stage 3 periodontitis Exclusion Criteria: - Having a systemic disease such as cardiovascular, diabetes, hypertension, thyroid organ pathologies, chronic kidney failure - Being pregnant/breastfeeding - Being on medication for any reason - Being a smoker/tobacco user - Having another periodontal disease other than periodontitis - Having a chronic inflammatory disease (COPD, asthma)

Study Design


Intervention

Other:
healthy
no intervention
periodontitis
no intervention

Locations

Country Name City State
Turkey Atatürk University Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary iodine deficiency iodine level of participants 0-1 hours of the diagnosis
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