An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease

Oxidative Stress Clinical Trial

Official title:

An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05724706
• Other study ID #: Z PEKCETIN-BAYAV
• Status: Completed
• Start date: September 1, 2016
• Est. completion date: March 13, 2018

Study information

• Verified date: February 2023
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

INTRODUCTION Inflammatory lesions that develop in the tissues surrounding implants are generally referred to as peri-implant diseases. Peri-implant disease has two subgroups; peri-implant mucositis, which is reversible inflammatory lesion limited to the surrounding mucosal tissues, and peri-impantitis which is characterized by bone destruction around the dental implants. Peri-implant disease develops as a result of a balance problem between bacterial loading and host response around an implant that has been correctly secured by osseointegration. Bacteria produce tissue destruction directly, via toxic products, and indirectly, by activating host defense systems; in other words, by inflammation. Various types of molecules are formed in inflammatory lesions; these include reactive species such as free radicals (FR) and reactive oxygen species (ROS). ROS are physiological formations that are the endogenous sources of the mitochondrial electron transport chain seen in every living organism. ROS occur as a natural product of normal oxygen metabolism, and play an important role in cell signals and hemostasis. ROS increase during inflammation; hence, oxidizing conditions increase and cell structures are damaged. This condition is known as oxidative stress (OS). OS depends on an increase in FR production and/or a decrease in the protective mechanism (antioxidant status), and OS is defined as a balance problem between oxidants and antioxidants in the body. Many studies support the idea that OS plays an important role in the etiology and severity of periodontal diseases. The etiology and the pathogenic mechanism are similar in the periodontitis and peri-implant diseases processes. However, those studies indicating the effect of OS on peri-implant tissues have used quite small groups or small numbers of biomarkers. The results obtained have been contradictory. Therefore, this 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bone Loss in Jaw
• Dental Implant Failed
• Dental Implant Failure Nos
• Oxidative Stress
• Peri-Implantitis

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Biruni University	Istanbul Arel University, Istanbul University

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

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).	4 month