Sclerostin Regulation in Apical Periodontitis Lesions in Apical Periodontitis Lesions

NCT06512103 | Completed

• 1 other identifier: 623
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim was to examine the relationship between inflammatory bone resorption associated with the severity of AP and gingival crevicular fluid (GCF) and blood sclerostin and PGE2 levels in cases of AP. Additionally, the correlation of sclerostin regulation with RANKL and MMP-9 levels will be investigated.This single-centered cross-sectional analytical study included 90 patients with AP and 35 systemically and orally healthy volunteers as the control group, who applied for a control examination between September 2023 and February 2024. Demographic characteristics of the patients (age, body mass index (BMI) and oral hygiene index (OHI)) and dental examination findings (periapical index (PAI) score, root canal treatment, number of crowns, fillings and missing teeth, etc.) were recorded. According to the PAI score, the participants were divided into three groups: 35 healthy patients with a PAI score of 1-2 (Group 1: Control group), 35 patients with a PAI score of 3-4 (Group 2: mild-moderate AP), and 55 patients having at least one tooth with PAI score of 5, characterized by more severe bone resorption (Group 3: Severe AP). Sclerostin, RANKL and MMP-9 levels were measured in serum and GCF of all participants.

Conditions

Apical Periodontitis

Keywords

Apical periodontitis; Bone resorption; Gingival crevicular fluid; Sklerostin; PGE2

Outcome Measures

Primary Outcomes (1)

• levels of sclerostin, RANKL, MMP-9 and PGE2 in gingival crevicular fluid

  correlation between periapical radiolucency and GCF levels will be evaluated

  baseline

Secondary Outcomes (1)

• levels of sclerostin, RANKL, MMP-9 and PGE2 in serum

  baseline

Study Arms (2)

Experimental: 90 patients with apical periodontitis (AP group)

AP group was divided into 3 subgroups. The participants in the study group were divided into two subgroups: 35 patients with a PAI score of 3-4 (Group 2: mild-moderate AP), and 55 patients with at least one tooth with a severity of PAI 5 (Group 3: Severe AP).

Diagnostic Test: Apical periodontitis group

Control: A healthy control group of 35 volunteers

A healthy control group of 35 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 control group. 35 healthy patients with a PAI score of 1-2 (Group 1: Control group) were included.

Diagnostic Test: Apical periodontitis group

Interventions

Apical periodontitis group DIAGNOSTIC_TEST

Radiography of the patients were taken. Blood samples and gingival crevicular fluid samples were collected from those patient

Also known as: Control group

Control: A healthy control group of 35 volunteers; Experimental: 90 patients with apical periodontitis (AP group)

Eligibility Criteria

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

Study Population

The study included 90 patients diagnosed with chronic apical periodontitis. 35 healthy volunteers who came to the dental clinic for check-up and periodic examination and did not have periodontal pathology, any acute/chronic disease.

You may qualify if:

• patients with chronic apical periodontitis having no periodontal pathology having no acute/chronic disease (muscle-joint-bone diseases, inflammatory bowel disease, local or generalized infection, severe organ disease, cardiovascular disease and diabetes mellitus)

You may not qualify if:

• Patients who had any acute/chronic disease (inflammatory and rheumatoid diseases, cardiovascular disease, muscle-joint-bone diseases, inflammatory bowel disease, local or generalized infection, connective tissue diseases and diabetes mellitus) patients who had a history of smoking pregnant and/or lactating patients antibiotics or anti-inflammatory drugs use within the last 6 months patients undergoing dental treatment having chronic marginal periodontitis along with AP patients with a history of using immunosuppressive drugs, steroid or nonsteroidal anti-inflammatory drugs use of high doses of biotin vitamin in the last 48 hours

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis; Bone Resorption

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ebru Uysal, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Associate Professor

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: July 22, 2024
• Study Start: August 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-07

Locations

TU (1)