Endodontic DiseaseNCT04211519
Analysis of Bacterial Microbiome of Endodontically Infected Primary and Permanent Teeth
A study testing sampling in people with Endodontic Disease and Endodontic Inflammation, run by Nuh Naci Yazgan University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Endodontic Disease, Endodontic Inflammation
- What is being tested?
- sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nuh Naci Yazgan Üniversitesi
Kayseri, Kocasinan, 38170
About this study
Official title: 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
Read the 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.
- Conditions
- Endodontic Disease, Endodontic Inflammation
- Being tested
- sampling
- Keywords
- Endodontic disease, Microbiome, Permanent teeth, Primary teeth
- Medical subject headings
- Dental Pulp Diseases, Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
samplingDiagnostic test
sampling from endodontically infected primary and permanent teeth by using paper point method
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Sep 2017
- Primary completion15 Feb 2018
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuh Naci Yazgan University
- Sponsor type
- University, hospital or other
- Collaborators
- Mersin University
- Responsible party
- Principal investigator, Ebru Delikan, Nuh Naci Yazgan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211519
- Sponsor's protocol ID
- 2017/234
- Status last verified
- Dec 2019
- First submitted
- 24 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mersin University Clinical Research Ethics Committee
- ClinicalTrials.gov ID
- NCT04211519
- Acronym / sponsor ID
- 2017/234
- Conditions
- Endodontic Disease, Endodontic Inflammation
- Keywords
- Endodontic disease, Microbiome, Permanent teeth, Primary teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nuh Naci Yazgan UniversityUniversity, hospital or other
- Collaborators
- Mersin University
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Permanent teeth group | Experimental | Diagnostic Test: samplingFor 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 | Experimental | Diagnostic Test: samplingFor 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. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| samplingsampling from endodontically infected primary and permanent teeth by using paper point method | Diagnostic test | Permanent teeth group, Primary teeth group |
Primary outcome
Comparison of microbiome composition of endodontically infected primary and permanent tooth canal
Time frame: 6 months
Analysis of the profile of microbial populations based on 16S rRNA gene analysis in endodontically infected permanent and primary teeth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Individual participant dataSharing planned: Undecided
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
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Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sampling in people with Endodontic Disease and Endodontic Inflammation, run by Nuh Naci Yazgan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of microbiome composition of endodontically infected primary and permanent tooth canal (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.