NCT04211519

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

December 24, 2019

Last Update Submit

December 24, 2019

Conditions

Keywords

Endodontic diseaseMicrobiomePermanent teethPrimary teeth

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

EXPERIMENTAL

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

Primary teeth group

EXPERIMENTAL

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

Interventions

samplingDIAGNOSTIC_TEST

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

Permanent teeth groupPrimary teeth group

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

Nuh Naci Yazgan Üniversitesi

Kayseri, Kocasinan, 38170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Pulp DiseasesPulpitis

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

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

Locations