Oxidative Stress Clinical Trial
Official title:
An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease
Verified date | February 2023 |
Source | Biruni University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Objectives: Inflammatory lesions develop in the tissues surrounding implants are referred to as peri-implant diseases. Oxidants, play a role in inflammatory lesions. The study aimed to determine oxidant and antioxidant levels in the saliva of patients with various levels of peri-implant diseases and the relationship between oxidative stress and peri-implant diseases. Material and methods: Sixty-seven patients with at least one dental implant applied in our clinic were included in the study. The patients were divided into 3 groups; with peri-implantitis (PI), with marginal bone loss (MBL) and with healthy peri-implant (HI) tissues. Twenty-one individuals who didn't have any dental implants were included the study as a healthy control group (HC). For oxidant concentration, total oxidant status (TOS), advanced oxidation protein products (AOPP), and for antioxidant concentration, total antioxidant status (TAS), were investigated.
Status | Completed |
Enrollment | 88 |
Est. completion date | March 13, 2018 |
Est. primary completion date | January 5, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 67 Years |
Eligibility | Inclusion Criteria: - Adults aged 18 and older; - Being systemically healthy; , - Being non-smokers; - For dental implant groups, at least 1 osseointegrated implant; - Dental implant applied by at least a specialist-level physician; - Dental implants having the same surface and the same design; - Correct prosthetic restoration of occlusal loading; - Dental implant having been in function for at least 6 months. Exclusion Criteria: - Any history of medical conditions; - Presence of active periodontal disease; - Use of antibiotic or anti-inflammatory medications in the past 3 months; - Pregnancy; - Use of AO supplements; - Smoking; - Poor oral hygiene; - Inflammation in the oral area; - Presence of active caries; - Presence of oral mucosal lesions such as oral lichen planus or recurrent aphthous stomatitis. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Biruni University | Istanbul Arel University, Istanbul University |
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identifying patients to be included in the study and collecting saliva samples | Patients to be included in the study were determined by clinical and radiological examinations, divided into groups, and saliva samples; it was collected to measure the total oxidant status (TOS) and advanced oxidation protein products (AOPP) to evaluate the oxidant concentration in it, and the total antioxidant status (TAS) to evaluate the antioxidant concentration in it and stored at -80 degrees Celsius. | 1 year | |
Secondary | Biochemical examination of oxidant and antioxidant biomarkers in saliva and statistical evaluation of the results | In biochemical analysis, For oxidant concentration in saliva, total oxidant status (TOS), advanced oxidation protein products (AOPP), and for antioxidant concentration, total antioxidant status (TAS), were investigated. The values of markers whose biochemical analysis were made in saliva were statistically analyzed and calculated.
Saliva TOS levels were reported as µM H2O2 equivalent per liter (µmol H2O2 Equiv/L). Saliva AOPP levels were reported as nmol / mL chloramine-T equivalent. Saliva TAS levels were reported as units of mM trolox equivalent per liter (mmol trolox Equiv/L). |
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