Relationship Apical Periodontitis and the Main Bacterial Species in the Oral Microbiota

NCT05857436 | Completed

• 1 other identifier: Oral Microbiota
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: Apical periodontitis(AP) caused by root canal infection is the most frequent pathological lesion in the jaws. Bacterial products, host immune cells and biologically active factors called locally produced cytokines(such as IL-1, TNF-α) have been reported to play an important role in the pathogenesis of AP. Metalloproteinases(MMP), is a measurable biomarker that plays an important role in the degradation and regeneration of collagen and is an indicator of collagen. This study aimed to determine the main bacterial species in the microbiota as Gr(+) and Gr(-) and to compare the relationship between MMP-9 and TNF-α with controlled patient groups. Methodology:60 patients with AP and extraction indication were included in the study. 30 systemically and orally healthy volunteers were selected as the control group. After access cavity preparation, an initial microbiologic sample(S1) was taken from the root canal. After atraumatic extraction of the tooth, second microbial sample(S2) was taken from the external root surface. After bacterial DNA extraction, 16S rRNA gene primer was designed for sequence analysis. Bacterial community profiling was made by Sanger sequencing of the PCR products. Besides, blood samples were collected from all of the patients. Enzyme-linked immunosorbent assay was used to measure levels of MMP-9 and TNF-α.

Conditions

Periapical Periodontitis; MMP-9

Outcome Measures

Primary Outcomes (1)

• Laboratory Analysis

  Blood samples were collected from the patients for MMP-9 and TNF-α analysis. The blood samples taken from the patients in a tube with a gel separator were kept at room temperature for 20-30 minutes to coagulate, and then centrifuged at 1800 g for 10 minutes. T

  The study was conducted between March 2022 and February 2023

Secondary Outcomes (2)

• Bacteriological Sampling from the Root Canal System and Outer Root Surface

  The study was conducted between March 2022 and February 2023

• ELISA measurement procedure of MMP-9 and TNF-α levels

  The study was conducted between March 2022 and February 2023

Study Arms (2)

apical periodontitis

EXPERIMENTAL

60 patients with AP and extraction indication (due to restorative causes and lesion size) were included in the study

Other: apical periodontitis

control

EXPERIMENTAL

A total of 30 volunteers who were determined to be systemically and orally healthy (not having AP indication), were included in the study as the control group.

Other: apical periodontitis

Interventions

apical periodontitis OTHER

Of these patients, 60 patients with AP and extraction indication (due to restorative causes and lesion size) were included in the study

apical periodontitis; control

Eligibility Criteria

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

You may qualify if:

• AP and extraction indication (due to restorative causes and lesion size) were included in the study

You may not qualify if:

• Patients who had any acute or chronic inflammatory disease, known infection status, history of trauma or surgical operation within 6 months that may affect MMP-9 levels, pregnant and/or lactating, malignity, morbid obesity, arthritis, immunologic diseases, cardiovascular diseases or use of vitamins with high biotin were not included in the study. Additionally, patients who used antibiotics or anti-inflammatory drugs within the last 6 months, and patients with periodontal disease were excluded from the study.

Sponsors & Collaborators

• Seyda Ersahan, DDS, PhD: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Seyda Ersahan, Assoc.Prof.

  IstanbulMedipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 12, 2023
• Study Start: November 15, 2021
• Primary Completion: November 15, 2022
• Study Completion: February 15, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

TU (1)