Clinical trial NCT06986044: EVALUATION OF SALIVA AND SERUM HEME OXYGENASE, ARYLESTERASE AND NUCLEAR FACTOR ERYTHROID 2-RELATED FACTOR 2 LEVELS IN PATIENTS WITH STAGE III PERIODONTITIS
Official title: EVALUATION OF SALIVA AND SERUM HEME OXYGENASE, ARYLESTERASE AND NUCLEAR FACTOR ERYTHROID 2-RELATED FACTOR 2 LEVELS IN PATIENTS WITH STAGE III PERIODONTITIS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Health
Periodontitis Stage III
Keywords: total antioxidan status
total oxidan status
oxidative stress index
arylesterase
heme oxygenase
nuclear factor erythroid 2 related factor 2
saliva
serum
stage III periodontitis
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: periodontally healthy 19 female and 18 male subjects with a mean age of 39.48 years.

periodontitis state III individuals, 20 females and 17 males with a mean age of 39.05 years.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: serum and saliva TAS (mmol Trolox Eq/L) levels
timeFrame: 6 months
measure: serum and saliva TOS (µmol H₂O₂ Eq/L) levels
timeFrame: 6 months
measure: serum and saliva OSI levels
timeFrame: 6 months
measure: serum and saliva ARE (U/L) levels
timeFrame: 6 months
measure: serum and saliva NRF-2 (ng/ml) levels
timeFrame: 6 months
measure: serum and saliva HO-1(ng/ml) levels
timeFrame: 6 months
Secondary outcomes:
measure: Gingival Index (GI)
timeFrame: 6 months
measure: Plaque Index (PI)
timeFrame: 6 months
measure: Bleeding on Probing Index (BoP)
timeFrame: 6 months
measure: Clinical Attachment Loss (CAL) (millimeter)
timeFrame: 6 months
measure: Pocket Depth (PD) (millimeter)
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi
state: Keçiören
Study officials:
References: