Analysis of Bacterial Microbiome of Endodontically Infected Primary and Permanent Teeth
Mersin University Clinical Research Ethics Committee
1 other identifier
interventional
30
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2019
CompletedFirst Submitted
Initial submission to the registry
December 24, 2019
CompletedFirst Posted
Study publicly available on registry
December 26, 2019
CompletedDecember 26, 2019
December 1, 2019
6 months
December 24, 2019
December 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Permanent teeth group
EXPERIMENTALFor 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.
Primary teeth group
EXPERIMENTALFor 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.
Interventions
sampling from endodontically infected primary and permanent teeth by using paper point method
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nuh Naci Yazgan Universitylead
- Mersin Universitycollaborator
Study Sites (1)
Nuh Naci Yazgan Üniversitesi
Kayseri, Kocasinan, 38170, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ebru Delikan
Study Record Dates
First Submitted
December 24, 2019
First Posted
December 26, 2019
Study Start
September 1, 2017
Primary Completion
February 15, 2018
Study Completion
December 10, 2019
Last Updated
December 26, 2019
Record last verified: 2019-12