Analysis of Bacterial Microbiome of Endodontically Infected Primary and Permanent Teeth

Mersin University Clinical Research Ethics Committee

Recognition of community profiles in endodontic infections may allow a better understanding of the pathogenesis of the disease and the establishment of more effective treatment protocols.

Therefore, the aim of the present study was to investigate bacterial diversity in endodontically infected primary and permanent teeth using 16S rRNA gene sequencing and QIIME 2TM (Quantitative Insights Into Microbial Ecology 2) bioinformatics pipeline

Study Overview

• Status: Completed
• Conditions: Endodontic Disease; Endodontic Inflammation
• Intervention / Treatment: Diagnostic test: sampling

Detailed Description

Endodontic infections are defined as an infection of the pulp and periapical tissues. This infection is caused by microorganisms that invade the pulp via dental caries or dental trauma. In these mixed population infections, anaerobic bacteria have been reported to be conspicuously dominant and the number of microorganisms per canal may vary. Traditionally, the endodontic microbiome has been identified by culture-based (phenotype-based) techniques. Inability to cultivate approximately 40-55% of bacteria in the endodontic microbiome, bias or inexperience of researchers may limit the results of cultural research. Microbiome-based new generation sequencing (NGS), which was initially used in ecological studies, has been widely used in recent years to identify bacterial diversity using the 16S ribosomal RNA (rRNA) gene in endodontic infections microbiome, bias or inexperience of researchers may limit the results of cultural research. There are few studies investigating the endodontic microbiome in primary teeth. However, to the best of our knowledge, to date, there is no metagenomic study that investigates the endodontic microbiome of the primary and permanent teeth. It is a still question of whether there is a difference in the endodontic microbiomes during the mixed dentition period when both dentition types can be seen.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocasinan
    • Kayseri, Kocasinan, Turkey, 38170
      • Nuh Naci Yazgan Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• have intact roots or <1/3 of physiological root resorption
• have clinical crowns that permit effective rubber dam isolation
• no mobility, fistula, pus discharge, gingival swelling, periapical abscess or internal resorption.

Exclusion Criteria:

• have marginal periodontitis, a history of pharmacological treatment, antibiotics or fluoride intake within the last 2 months
• a history of cancer, diabetes or immunodeficiency disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Permanent teeth group; For the disinfection of teeth, 30% hydrogen peroxide and 2.5% sodium hypochlorite solution were used for 30 seconds each. Then, 5% sodium thiosulfate solution was used to inactivate the disinfectant agents. Cavity preparation and root canal access were accomplished using sterile high-speed diamond burs under water cooling. Microbial samples were taken immediately by the same researcher from the largest root canal under strict aseptic conditions by using paper point method. Sterilized minimum four paper points were placed to the same level in root canal and the root canal content was absorbed. Each paper point was kept into the canal for at least 30 seconds. Then, paper points were placed into the Eppendorf tubes and refrigerated at -80 °C within 10 min.	Diagnostic test: sampling; sampling from endodontically infected primary and permanent teeth by using paper point method
EXPERIMENTAL: Primary teeth group; For the disinfection of teeth, 30% hydrogen peroxide and 2.5% sodium hypochlorite solution were used for 30 seconds each. Then, 5% sodium thiosulfate solution was used to inactivate the disinfectant agents. Cavity preparation and root canal access were accomplished using sterile high-speed diamond burs under water cooling. Microbial samples were taken immediately by the same researcher from the largest root canal under strict aseptic conditions by using paper point method. Sterilized minimum four paper points were placed to the same level in root canal and the root canal content was absorbed. Each paper point was kept into the canal for at least 30 seconds. Then, paper points were placed into the Eppendorf tubes and refrigerated at -80 °C within 10 min.	Diagnostic test: sampling; sampling from endodontically infected primary and permanent teeth by using paper point method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of microbiome composition of endodontically infected primary and permanent tooth canal	Analysis of the profile of microbial populations based on 16S rRNA gene analysis in endodontically infected permanent and primary teeth	6 months

Collaborators and Investigators

• Sponsor: Nuh Naci Yazgan University
• Collaborators: Mersin University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): February 15, 2018
• Study Completion (ACTUAL): December 10, 2019

Study Registration Dates

• First Submitted: December 24, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (ACTUAL): December 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Microbiome; Primary teeth; Permanent teeth; Endodontic disease
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Tooth Diseases; Inflammation; Pulpitis; Dental Pulp Diseases
• Other Study ID Numbers: 2017/234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No