The Importance of Prostaglandin and Nitric Oxide Synthesis in Apical Periodontitis

NCT06023901 | Completed DMC

• 1 other identifier: E-10840098-772.02-2860/344
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 185 subjects were divided into three categories: AP group (n=85), CP group (n=50) and healthy control group (n=50). The AP group was divided into 3 subgroups according to abscess scoring (AS-PAI) based on the periapical index. The CP group was divided into 4 subgroups according to the periodontitis staging system (PSS). After recording the demographic and clinical characteristics of all participants, blood and gingival crevicular fluid (GCF) samples were taken. TNF-α, IL-10, PGE2 and NO levels were measured in these samples.

Conditions

Periapical Periodontitis

Keywords

Gingival crevicular fluid; Apical periodontitis; Chronic periodontitis

Outcome Measures

Primary Outcomes (2)

• The inflammatory markers TNF-α, IL-1β, IL-6 and IL-10,17

  TNF-α, IL-1β, IL-6 and IL-10,17 were measured by ELISA analysis.

  Through study completion, an average of 1 year

• The biomarkers with protective functions such as PGE2 and NO2

  PGE2 and NO2 were measured by ELISA analysis.

  Through study completion, an average of 1 year

Study Arms (3)

85 patients with only apical periodontitis (AP group)

EXPERIMENTAL

AP group was divided into 3 subgroups. AS-PAI 1 (mild): those having at least 1 tooth with either PAI 3 or PAI 4, AS-PAI 2 (moderate): those having only 1 tooth with a PAI 5, AS-PAI 3 (severe): those having two or more teeth with a PAI 5.

Diagnostic Test: Apical periodontitis

50 patients with only chronic periodontitis (CP group),

EXPERIMENTAL

In this study, the CP group was divided into 4 subgroups according to the periodontitis staging system (PSS) (Tonetti). This system classifies the periodontitis from I to IV according to the interdental clinical attachment loss (CAL), radiographic bone loss (RBL) and tooth loss. This scoring is as follows: Stage 1: CAL 1 to 2 mm, RBL is at coronal third (\<15%) and no tooth loss, Stage 2: CAL 3 to 4 mm, RBL is at coronal third (15% to 33%) and no tooth loss, Stage 3: CAL \> 5 mm, RBL is extending to mid-third of root and beyond and tooth loss \< 4 teeth, and Stage 4: CAL \> 5 mm, RBL is extending to mid-third of root and beyond and tooth loss \> 5 teeth. However, Stage 1 and 2 were evaluated in the same group due to the low number of cases. As a result, the groups were designed as Stage 1-2: PSS 1-2, Stage 2: PSS 2 and Stage 3: PSS 3.

Diagnostic Test: Apical periodontitis

A healthy control group of 50 volunteers

NO INTERVENTION

control group. A healthy control group of 50 volunteers without periodontal pathology as well as any acute/chronic disease (muscle/joint/bone diseases, inflammatory bowel disease, local or generalized infection, severe organ disease, cardiovascular disease and diabetes mellitus) were included in the study.

Interventions

Apical periodontitis DIAGNOSTIC_TEST

Radiography of the patients were taken. Blood samples were collected from those patient

Also known as: Chronic periodontitis

50 patients with only chronic periodontitis (CP group),; 85 patients with only apical periodontitis (AP group)

Eligibility Criteria

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

You may qualify if:

• Apical periodontitis (AP) and/or chronic periodontitis (CP)
• Patients who had taken antibiotics and/or anti-inflammatory drugs within the last 6 months - - Without periodontal pathology as well as any acute/chronic disease (muscle/joint/bone diseases, inflammatory bowel disease, local or generalized infection, severe organ disease, cardiovascular disease and diabetes mellitus) were included in the study

You may not qualify if:

• with pregnancy or lactation were also excluded.
• with a history of using steroid or nonsteroidal anti-inflammatory drugs and high-dose biotin vitamin in the last 48 hours were excluded from the study.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry

Istanbul, ESENLER, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Associate Professor

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: January 7, 2021
• Primary Completion: January 2, 2022
• Study Completion: August 2, 2023
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

TU (1)