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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04211519
Other study ID # 2017/234
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date December 10, 2019

Study information

Verified date December 2019
Source Nuh Naci Yazgan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 10, 2019
Est. primary completion date February 15, 2018
Accepts healthy volunteers No
Gender All
Age group 4 Years to 13 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
sampling
sampling from endodontically infected primary and permanent teeth by using paper point method

Locations

Country Name City State
Turkey Nuh Naci Yazgan Üniversitesi Kayseri Kocasinan

Sponsors (2)

Lead Sponsor Collaborator
Nuh Naci Yazgan University Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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