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

Sponsor

Biruni University (Other)

Overall Status

Completed

CT.gov ID

NCT05724706

Collaborator

Istanbul University (Other), Istanbul Arel University (Other)

Enrollment

18.3

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Peri-Implantitis Bone Loss in Jaw Dental Implant Failed Dental Implant Failure Nos Oxidative Stress

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

88 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Jan 5, 2018

Actual Study Completion Date :

Mar 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patients with peri-implantitis (PI) The PI group consisted of 23 patients (9M/14F) with ages ranging from 29 to 66 years (mean 51,91 ± 10,63). This group was selected based on the success criteria of Misch et al. 2008; patients with clinical findings such as bleeding and/or sweeping in their implants, pain or tenderness during function, and exudation in peri-implant tissues, with at least 1 implant with a pocket depth of more than 7 mm and radiographic bone loss of at least 4 mm or more around the implant were included.
Patients with marginal bone loss (MBL) The MBL group consisted of 22 patients (14M /8F) aged between 27 and 67 years (mean 53,00 ± 8,92). This group was based on the success criteria defined by Misch et al. 2008; patients for whom, in the clinical examination of implants, there was no bleeding, non-sweeping, non-mobility, with no exudation history of peri-implant tissues, no pain or sensitivity when in function, and there was at least 1 implant with 2-4 mm radiographic bone loss around the implant were included.
Patients with healthy peri-implant tissues (HI) The HI group consisted of 22 patients(7M/15F) with ages ranging from 29 to 62 years (mean 51,00 ± 8,45). This group was based on the success criteria defined by Misch et al. in 2008: Patients with no history of exudation in the periimplant tissues, no bleeding and suppuration during probing, no pain or sensitivity in function, no mobility, and at least 1 implant with a radiographic bone loss around the implant of less than 2 mm were included.
Healthy control (HC) 21 individuals (8M/ 13F) whose ages ranged between 27 and 67 (mean 21.88 ± 11.21 years), who did not have any dental implants, and who were selected among the patient community were included the study as a healthy control group (HC).

Outcome Measures

Primary Outcome Measures

Identifying patients to be included in the study and collecting saliva samples [1 year]
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.

Secondary Outcome Measures

Biochemical examination of oxidant and antioxidant biomarkers in saliva and statistical evaluation of the results [4 month]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 67 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Biruni University
Istanbul University
Istanbul Arel University

Investigators

Study Director: ZEYNEP S PEKCETIN-BAYAV, ASST. PROF., Biruni University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Zeynep Seda Pekcetin-Bayav, Assistant Professor Doctor, Biruni University

ClinicalTrials.gov Identifier:

NCT05724706

Other Study ID Numbers:

Z PEKCETIN-BAYAV

First Posted:

Feb 13, 2023

Last Update Posted:

Feb 13, 2023

Last Verified:

Feb 1, 2023

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 Zeynep Seda Pekcetin-Bayav, Assistant Professor Doctor, Biruni University

Additional relevant MeSH terms:

Peri-Implantitis

Study Results

No Results Posted as of Feb 13, 2023