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

NCT05724706 | Completed

• 1 other identifier: Z PEKCETIN-BAYAV
• Study Type: observational
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

oxidant; antioxidant; oxidative stress; Peri-implantitis; Marginal bone loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Biochemical examination of oxidant and antioxidant biomarkers in saliva and statistical evaluation of the results

  4 month

Study Arms (4)

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).

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Group 1: Patients with peri-implantitis (PI); The PI group consisted of 23 patients (9M/14F) with ages ranging from 29 to 66 years Group 2: Patients with marginal bone loss (MBL); The MBL group consisted of 22 patients (14M /8F) aged between 27 and 67 years Group 3: Patients with healthy peri-implant tissues (HI); The HI group consisted of 22 patients(7M/15F) with ages ranging from 29 to 62 years Group 4: Healthy control (HC) 21 individuals (8M/ 13F) whose ages ranged between 27 and 67 years

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biruni University: lead
• Istanbul University: collaborator
• Istanbul Arel University: collaborator

Related Publications (28)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

unstimulated saliva samples

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• ZEYNEP S PEKCETIN-BAYAV, ASST. PROF.

  Biruni University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Doctor

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: February 13, 2023
• Study Start: September 1, 2016
• Primary Completion: January 5, 2018
• Study Completion: March 13, 2018
• Last Updated: February 13, 2023

Record last verified: 2023-02