EVALUATION OF SALIVA AND SERUM HEME OXYGENASE, ARYLESTERASE AND NUCLEAR FACTOR ERYTHROID 2-RELATED FACTOR 2 LEVELS IN PATIENTS WITH STAGE III PERIODONTITIS

NCT ID: NCT06986044

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Periodontal disease is a chronic and progressive inflammatory disease in which the hard and soft tissues that support the teeth are damaged. It is caused by the interaction between harmful bacteria and the body's immune responses, and most periodontal tissues are damaged by the body's abnormal response to these microorganisms and their products. When bacteria enter the body, immune cells (neutrophils) produce reactive oxygen species (ROS) in a process called the "respiratory burst". These ROS damage cells, causing tissue destruction through a variety of mechanisms, including DNA damage, fat oxidation and protein damage. Studies have shown that neutrophils from individuals with periodontal disease produce more ROS than neutrophils from healthy individuals. High amounts of ROS lead to oxidative damage to gum tissue, periodontal ligament and alveolar bone. Oxidative stress occurs when antioxidants in the body are insufficient or when high levels of ROS are present. Therefore, disruption of the balance between oxidant and antioxidant activities is considered an important cause of oxidative damage in periodontal tissues. Parameters such as total antioxidant status (TAS), total oxidant status (TOS) and oxidative stress index (OSI) are used to determine oxidative stress.

Furthermore, some enzymes such as arylesterase (ARE), heme oxygenase (HO) and nuclear factor erythroid 2-related factor 2 (NRF-2) are involved in defense mechanisms against oxidative stress. Many recent studies have shown a strong association between oxidative stress and periodontal disease.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study was divided into 2 groups, 37 systemically and periodontally health individuals and 37 systemically healthy individuals with stage III grade B periodontitis were included. Clinical periodontal parameters plaque index (PI), gingival index (GI), probing pocket depth (SCD), bleeding on probing (BOP) and clinical attachment level (CAL) were recorded and saliva and serum samples were collected. ELISA method was used for analyses of TOS, TAS, OSI, ARE, HO-1, NRF-2 levels.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontal Health Periodontitis Stage III

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

stage III grade B periodontitis

Pocket deep ≤ 6 mm, clinical attachment loss ≥ 5 mm, tooth loss related to periodontitis ≤ 4, radiographic bone loss/age between 0.25-1 and periodontal tissue destruction compatible with biofilm accumulation.

Serum Total Oxidant Status

Intervention Type DIAGNOSTIC_TEST

Serum total oxidant status

Salivary Total Oxidant Status

Intervention Type DIAGNOSTIC_TEST

Salivary Total Oxidant Status

Serum Total Antioxidant Status

Intervention Type DIAGNOSTIC_TEST

Serum Total Antioxidant Status

Salivary Total Antioxidant Status

Intervention Type DIAGNOSTIC_TEST

Salivary Total Antioxidant Status

Serum Oxidative Stress Index

Intervention Type DIAGNOSTIC_TEST

Serum Oxidative Stress Index

Salivary Oxidative Stress Index

Intervention Type DIAGNOSTIC_TEST

Salivary Oxidative Stress Index

Serum Arylesterase

Intervention Type DIAGNOSTIC_TEST

Serum Arylesterase

Salivary Arylesterase

Intervention Type DIAGNOSTIC_TEST

Salivary Arylesterase

Serum Heme Oxygenase

Intervention Type DIAGNOSTIC_TEST

Serum Heme Oxygenase

Salivary Heme Oxygenase

Intervention Type DIAGNOSTIC_TEST

Salivary Heme Oxygenase

Serum Nuclear Factor Erythroid 2 Related Factor 2

Intervention Type DIAGNOSTIC_TEST

Serum Nuclear Factor Erythroid 2 Related Factor 2

Salivary Nuclear Factor Erythroid 2 Related Factor 2

Intervention Type DIAGNOSTIC_TEST

Salivary Nuclear Factor Erythroid 2 Related Factor 2

Gingival Index

Intervention Type DIAGNOSTIC_TEST

Gingival Index

Plaque Index

Intervention Type DIAGNOSTIC_TEST

Plaque Index

Bleeding on Probing Index

Intervention Type DIAGNOSTIC_TEST

Bleeding on Probing Index

Clinical Attachment Loss

Intervention Type DIAGNOSTIC_TEST

Clinical Attachment Loss

Pocket Deep

Intervention Type DIAGNOSTIC_TEST

Pocket Deep

periodontally health

Pocket deep ≤ 3 mm, bleeding on probing index ≤ %10 and gingival index ≤ 1

Serum Total Oxidant Status

Intervention Type DIAGNOSTIC_TEST

Serum total oxidant status

Salivary Total Oxidant Status

Intervention Type DIAGNOSTIC_TEST

Salivary Total Oxidant Status

Serum Total Antioxidant Status

Intervention Type DIAGNOSTIC_TEST

Serum Total Antioxidant Status

Salivary Total Antioxidant Status

Intervention Type DIAGNOSTIC_TEST

Salivary Total Antioxidant Status

Serum Oxidative Stress Index

Intervention Type DIAGNOSTIC_TEST

Serum Oxidative Stress Index

Salivary Oxidative Stress Index

Intervention Type DIAGNOSTIC_TEST

Salivary Oxidative Stress Index

Serum Arylesterase

Intervention Type DIAGNOSTIC_TEST

Serum Arylesterase

Salivary Arylesterase

Intervention Type DIAGNOSTIC_TEST

Salivary Arylesterase

Serum Heme Oxygenase

Intervention Type DIAGNOSTIC_TEST

Serum Heme Oxygenase

Salivary Heme Oxygenase

Intervention Type DIAGNOSTIC_TEST

Salivary Heme Oxygenase

Serum Nuclear Factor Erythroid 2 Related Factor 2

Intervention Type DIAGNOSTIC_TEST

Serum Nuclear Factor Erythroid 2 Related Factor 2

Salivary Nuclear Factor Erythroid 2 Related Factor 2

Intervention Type DIAGNOSTIC_TEST

Salivary Nuclear Factor Erythroid 2 Related Factor 2

Gingival Index

Intervention Type DIAGNOSTIC_TEST

Gingival Index

Plaque Index

Intervention Type DIAGNOSTIC_TEST

Plaque Index

Bleeding on Probing Index

Intervention Type DIAGNOSTIC_TEST

Bleeding on Probing Index

Clinical Attachment Loss

Intervention Type DIAGNOSTIC_TEST

Clinical Attachment Loss

Pocket Deep

Intervention Type DIAGNOSTIC_TEST

Pocket Deep

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Serum Total Oxidant Status

Serum total oxidant status

Intervention Type DIAGNOSTIC_TEST

Salivary Total Oxidant Status

Salivary Total Oxidant Status

Intervention Type DIAGNOSTIC_TEST

Serum Total Antioxidant Status

Serum Total Antioxidant Status

Intervention Type DIAGNOSTIC_TEST

Salivary Total Antioxidant Status

Salivary Total Antioxidant Status

Intervention Type DIAGNOSTIC_TEST

Serum Oxidative Stress Index

Serum Oxidative Stress Index

Intervention Type DIAGNOSTIC_TEST

Salivary Oxidative Stress Index

Salivary Oxidative Stress Index

Intervention Type DIAGNOSTIC_TEST

Serum Arylesterase

Serum Arylesterase

Intervention Type DIAGNOSTIC_TEST

Salivary Arylesterase

Salivary Arylesterase

Intervention Type DIAGNOSTIC_TEST

Serum Heme Oxygenase

Serum Heme Oxygenase

Intervention Type DIAGNOSTIC_TEST

Salivary Heme Oxygenase

Salivary Heme Oxygenase

Intervention Type DIAGNOSTIC_TEST

Serum Nuclear Factor Erythroid 2 Related Factor 2

Serum Nuclear Factor Erythroid 2 Related Factor 2

Intervention Type DIAGNOSTIC_TEST

Salivary Nuclear Factor Erythroid 2 Related Factor 2

Salivary Nuclear Factor Erythroid 2 Related Factor 2

Intervention Type DIAGNOSTIC_TEST

Gingival Index

Gingival Index

Intervention Type DIAGNOSTIC_TEST

Plaque Index

Plaque Index

Intervention Type DIAGNOSTIC_TEST

Bleeding on Probing Index

Bleeding on Probing Index

Intervention Type DIAGNOSTIC_TEST

Clinical Attachment Loss

Clinical Attachment Loss

Intervention Type DIAGNOSTIC_TEST

Pocket Deep

Pocket Deep

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* systemically healthy
* between the ages of 18-65

Exclusion Criteria

* Patients with systemic diseases and/or conditions that may affect periodontal tissues (cardiovascular diseases, immune system diseases, rheumatoid arthritis, diabetes mellitus, chemotherapy/radiotherapy).
* taking any medication that may have an effect on periodontal tissues,
* less than 20 natural teeth excluding third molars
* used antibiotics, anti-inflammatory or immunosuppressive drugs
* periodontal treatment in the last 6 months
* smokers
* pregnant or lactating women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zeynep Hazan YILDIZ

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi

Ankara, Keçiören, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GülhaneDiş

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.