Root Canal InfectionNCT07047027
Comparative Analysis of Root Canal Microbiota in Diabetic and Systemically Healthy Patients
An observational study of Root Canal Infection, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study was to assess the influence of Diabetes Mellitus on the microbial flora involved in root canal infections through a comparative analysis with that of systemically healthy patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2024to 13 Mar 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who were attended to the faculty of dentistry
Inclusion Criteria:The inclusion criteria for patient selection were as follows: patients in the diabetic group were required to have a diagnosis of type 2 Diabetes Mellitus with no other systemic diseases; patients in the control group had to be systemically healthy with no history of any systemic illness. All participants must not have used antibiotics within the past three months, must not be pregnant, and must have teeth with intact coronal restorations that prevent direct pulp exposure to the oral environment. Only asymptomatic teeth diagnosed with chronic apical periodontitis and a Periapical Index (PAI) score of 3 or higher were included -
Exclusion Criteria:The exclusion criteria were: teeth with extensive coronal destruction that would prevent rubber dam isolation, presence of pain, swelling, or sinus tract, presence of root or crown fractures, and periodontal pockets deeper than 3 mm.
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Dentistry of Bulent Ecevit University, Zonguldak,
Zonguldak
About this study
Official title: Microbial Communities in Root Canal Infections of Patients With Diabetes.
The objective of this study was to assess the influence of Diabetes Mellitus on the microbial flora involved in root canal infections through a comparative analysis with that of systemically healthy patients.
Read the detailed description
A total of 39 participants aged 18 to 65 years were enrolled in the study, including 21 patients with Diabetes Mellitus and 18 systemically healthy individuals (controls). In the diabetic group, 12 teeth were diagnosed with persistent endodontic infections (SEI) and 9 with primary endodontic infections (PEI). In the healthy group, 12 teeth presented with SEI and 6 with PEI. Root canal samples were obtained using sterile paper points, transferred into Eppendorf tubes containing phosphate-buffered saline (PBS), and stored at -80 °C until analysis. The V3-V4 hypervariable regions of 16S rRNA from both sample types were amplified and sequenced using the Illumina MiSeq platform. Amplicon sequence variants (ASVs), generated via the DADA2 pipeline, were analyzed in the QIIME2 environment and taxonomically assigned using the SILVA database. Microbial richness and diversity were assessed using alpha diversity indices (Chao1, Shannon, Simpson, Faith's PD, Fisher alpha) and beta diversity metrics (Bray-Curtis, Jaccard, Unweighted UniFrac, and Weighted UniFrac). Alpha and beta diversity metrics were compared using the Kruskal-Wallis test and pairwise permutational multivariate analysis of variance (PERMANOVA), respectively, via the phyloseq package in R (version 4.1). Differentially abundant taxa were identified using Linear Discriminant Analysis Effect Size (LEfSe).
- Conditions
- Root Canal Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial analysis
Root canal microbial flora
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start2 Sep 2024
- Primary completion21 Feb 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevinç Aktemur Türker, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047027
- Sponsor's protocol ID
- 2024-27194235-03
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Communities in Root Canal Infections of Patients With Diabetes.
- ClinicalTrials.gov ID
- NCT07047027
- Acronym / sponsor ID
- 2024-27194235-03
- Conditions
- Root Canal Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 2 Jul 2025 (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.
The objective of this study was to assess the influence of Diabetes Mellitus on the microbial flora involved in root canal infections through a comparative analysis with that of systemically healthy patients.
Detailed description
A total of 39 participants aged 18 to 65 years were enrolled in the study, including 21 patients with Diabetes Mellitus and 18 systemically healthy individuals (controls). In the diabetic group, 12 teeth were diagnosed with persistent endodontic infections (SEI) and 9 with primary endodontic infections (PEI). In the healthy group, 12 teeth presented with SEI and 6 with PEI. Root canal samples were obtained using sterile paper points, transferred into Eppendorf tubes containing phosphate-buffered saline (PBS), and stored at -80 °C until analysis. The V3-V4 hypervariable regions of 16S rRNA from both sample types were amplified and sequenced using the Illumina MiSeq platform. Amplicon sequence variants (ASVs), generated via the DADA2 pipeline, were analyzed in the QIIME2 environment and taxonomically assigned using the SILVA database. Microbial richness and diversity were assessed using alpha diversity indices (Chao1, Shannon, Simpson, Faith's PD, Fisher alpha) and beta diversity metrics (Bray-Curtis, Jaccard, Unweighted UniFrac, and Weighted UniFrac). Alpha and beta diversity metrics were compared using the Kruskal-Wallis test and pairwise permutational multivariate analysis of variance (PERMANOVA), respectively, via the phyloseq package in R (version 4.1). Differentially abundant taxa were identified using Linear Discriminant Analysis Effect Size (LEfSe).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were attended to the faculty of dentistry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbial analysis
Time frame: 8 weeks
Root canal microbial flora
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 2 Jul 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Root Canal Infection, run by Bulent Ecevit 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?
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 2 Jul 2025. 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?
Microbial analysis (time frame: 8 weeks). 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 2 Jul 2025.