Periapical PeriodontitisNCT05857436
Relationship Apical Periodontitis and the Main Bacterial Species in the Oral Microbiota
A study testing apical periodontitis in people with Periapical Periodontitis and MMP-9, run by Seyda Ersahan, DDS, PhD at 1 site in Turkey (Türkiye).
Trial summary
Aim: Apical periodontitis(AP) caused by root canal infection is the most frequent pathological lesion in the jaws. Bacterial products, host immune cells and biologically active factors called locally produced cytokines(such as IL-1, TNF-α) have been reported to play an important role in the pathogenesis of AP. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis, MMP-9
- What is being tested?
- apical periodontitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 Feb 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AP and extraction indication (due to restorative causes and lesion size) were included in the study
Who cannot join
- Patients who had any acute or chronic inflammatory disease, known infection status, history of trauma or surgical operation within 6 months that may affect MMP-9 levels, pregnant and/or lactating, malignity, morbid obesity, arthritis, immunologic diseases, cardiovascular diseases or use of vitamins with high biotin were not included in the study. Additionally, patients who used antibiotics or anti-inflammatory drugs within the last 6 months, and patients with periodontal disease were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, Faculty of Dentistry
Istanbul, Esenler
About this study
Official title: Relationship of MMP-9 With the Clinical Course of Apical Periodontitis and the Main Bacterial Species in the Oral Microbiota
Aim: Apical periodontitis(AP) caused by root canal infection is the most frequent pathological lesion in the jaws. Bacterial products, host immune cells and biologically active factors called locally produced cytokines(such as IL-1, TNF-α) have been reported to play an important role in the pathogenesis of AP. Metalloproteinases(MMP), is a measurable biomarker that plays an important role in the degradation and regeneration of collagen and is an indicator of collagen. This study aimed to determine the main bacterial species in the microbiota as Gr(+) and Gr(-) and to compare the relationship between MMP-9 and TNF-α with controlled patient groups. Methodology:60 patients with AP and extraction indication were included in the study. 30 systemically and orally healthy volunteers were selected as the control group. After access cavity preparation, an initial microbiologic sample(S1) was taken from the root canal. After atraumatic extraction of the tooth, second microbial sample(S2) was taken from the external root surface. After bacterial DNA extraction, 16S rRNA gene primer was designed for sequence analysis. Bacterial community profiling was made by Sanger sequencing of the PCR products. Besides, blood samples were collected from all of the patients. Enzyme-linked immunosorbent assay was used to measure levels of MMP-9 and TNF-α.
Read the detailed description
60 patients with AP and extraction indication were included in the study. 30 systemically and orally healthy volunteers were selected as the control group. After access cavity preparation, an initial microbiologic sample(S1) was taken from the root canal. After atraumatic extraction of the tooth, second microbial sample(S2) was taken from the external root surface. After bacterial DNA extraction, 16S rRNA gene primer was designed for sequence analysis. Bacterial community profiling was made by Sanger sequencing of the PCR products. Besides, blood samples were collected from all of the patients. Enzyme-linked immunosorbent assay was used to measure levels of MMP-9 and TNF-α Approximately 450 patients who applied to xxxx University, Faculty of Dentistry, Endodontics Department for routine examination due to apical periodontitis complaints were examined and their demographic characteristics were recorded. Patients who had any acute or chronic inflammatory disease, known infection status, history of trauma or surgical operation within 6 months that may affect MMP-9 levels, pregnant and/or lactating, malignity, morbid obesity, arthritis, immunologic diseases, cardiovascular diseases or use of vitamins with high biotin were not included in the study. Additionally, patients who used antibiotics or anti-inflammatory drugs within the last 6 months, and patients with periodontal disease were excluded from the study. Of these patients, 60 patients with AP and extraction indication (due to restorative causes and lesion size) were included in the study. A total of 30 volunteers who were determined to be systemically and orally healthy (not having AP indication), were included in the study as the control group. The study was conducted between March 2022 and February 2023.
Demographic Characteristics \& Clinical and Radiographic Evaluation Laboratory Analysis ELISA measurement procedure of MMP-9 and TNF-α levels Bacteriological Sampling from the Root Canal System and Outer Root Surface Genomic DNA Isolation and Measurement of DNA Concentration PCR (16S Universal primer) Purification and sequencing of the 16S rRNA gene Power Analysis and Sample Size Calculations
- Conditions
- Periapical Periodontitis, MMP-9
- Being tested
- apical periodontitis
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apical periodontitisOther
Of these patients, 60 patients with AP and extraction indication (due to restorative causes and lesion size) were included in the study
| Study group | Role | What they receive |
|---|---|---|
| apical periodontitis | Experimental | 60 patients with AP and extraction indication (due to restorative causes and lesion size) were included in the study Receives: Other: apical periodontitis |
| control | Experimental | A total of 30 volunteers who were determined to be systemically and orally healthy (not having AP indication), were included in the study as the control group. Receives: Other: apical periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory Analysis
Blood samples were collected from the patients for MMP-9 and TNF-α analysis. The blood samples taken from the patients in a tube with a gel separator were kept at room temperature for 20-30 minutes to coagulate, and then centrifuged at 1800 g for 10 minutes. T
Measured: The study was conducted between March 2022 and February 2023
Secondary outcomes (2)
Bacteriological Sampling from the Root Canal System and Outer Root Surface
After plaque removal and rubber dam isolation, the operative field was cleaned with 3% hydrogen peroxide and disinfected with 2.5% NaOCl solution. Then, old coronal restorations if present and carious defects were removed, and an access preparation was completed when the root canal space was properly exposed. Afterwards, the tooth (including the pulp chamber), clamp and adjacent rubber dam were once again disinfected with 2.5% NaOCl, followed by inactivation with 10% sodium thiosulfate in order to avoid interference with bacteriological sampling. The working length (WL) was established 1-mm short of the apical foramen with an apex locator (Raypex6; VDW GmbH).
Measured: The study was conducted between March 2022 and February 2023
ELISA measurement procedure of MMP-9 and TNF-α levels
BT lab branded Human Matrix Metalloproteinase 9 and Human Tumor Necrosis Factor-α ELISA Kits (Shangai, China) were used to measure MMP-9 and TNF-α levels. The sensitivity of the kits is 15.12 ng/L and 1.520 pg/mL, respectively, and the measuring range of the kit is 30 - 9000 ng/L and 3 - 900 pg/mL, respectively. The within-run coefficient of variation is < 10%. In the study, measurements were made using BIO-TEK ELx500 ELISA Reader and BIO-TEK ELx50 (USA) washing devices.
Measured: The study was conducted between March 2022 and February 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start15 Nov 2021
- Primary completion15 Nov 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seyda Ersahan, DDS, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seyda Ersahan, DDS, PhD, Istanbul Medipol University Hospital
- Investigators
- Seyda Ersahan, Assoc.Prof., Principal investigator, IstanbulMedipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857436
- Sponsor's protocol ID
- Oral Microbiota
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of MMP-9 With the Clinical Course of Apical Periodontitis and the Main Bacterial Species in the Oral Microbiota
- ClinicalTrials.gov ID
- NCT05857436
- Acronym / sponsor ID
- Oral Microbiota
- Conditions
- Periapical Periodontitis, MMP-9
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seyda Ersahan, DDS, PhDUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 12 May 2023 (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.
Aim: Apical periodontitis(AP) caused by root canal infection is the most frequent pathological lesion in the jaws. Bacterial products, host immune cells and biologically active factors called locally produced cytokines(such as IL-1, TNF-α) have been reported to play an important role in the pathogenesis of AP. Metalloproteinases(MMP), is a measurable biomarker that plays an important role in the degradation and regeneration of collagen and is an indicator of collagen. This study aimed to determine the main bacterial species in the microbiota as Gr(+) and Gr(-) and to compare the relationship between MMP-9 and TNF-α with controlled patient groups. Methodology:60 patients with AP and extraction indication were included in the study. 30 systemically and orally healthy volunteers were selected as the control group. After access cavity preparation, an initial microbiologic sample(S1) was taken from the root canal. After atraumatic extraction of the tooth, second microbial sample(S2) was taken from the external root surface. After bacterial DNA extraction, 16S rRNA gene primer was designed for sequence analysis. Bacterial community profiling was made by Sanger sequencing of the PCR products. Besides, blood samples were collected from all of the patients. Enzyme-linked immunosorbent assay was used to measure levels of MMP-9 and TNF-α.
Detailed description
60 patients with AP and extraction indication were included in the study. 30 systemically and orally healthy volunteers were selected as the control group. After access cavity preparation, an initial microbiologic sample(S1) was taken from the root canal. After atraumatic extraction of the tooth, second microbial sample(S2) was taken from the external root surface. After bacterial DNA extraction, 16S rRNA gene primer was designed for sequence analysis. Bacterial community profiling was made by Sanger sequencing of the PCR products. Besides, blood samples were collected from all of the patients. Enzyme-linked immunosorbent assay was used to measure levels of MMP-9 and TNF-α Approximately 450 patients who applied to xxxx University, Faculty of Dentistry, Endodontics Department for routine examination due to apical periodontitis complaints were examined and their demographic characteristics were recorded. Patients who had any acute or chronic inflammatory disease, known infection status, history of trauma or surgical operation within 6 months that may affect MMP-9 levels, pregnant and/or lactating, malignity, morbid obesity, arthritis, immunologic diseases, cardiovascular diseases or use of vitamins with high biotin were not included in the study. Additionally, patients who used antibiotics or anti-inflammatory drugs within the last 6 months, and patients with periodontal disease were excluded from the study. Of these patients, 60 patients with AP and extraction indication (due to restorative causes and lesion size) were included in the study. A total of 30 volunteers who were determined to be systemically and orally healthy (not having AP indication), were included in the study as the control group. The study was conducted between March 2022 and February 2023.
Demographic Characteristics \& Clinical and Radiographic Evaluation Laboratory Analysis ELISA measurement procedure of MMP-9 and TNF-α levels Bacteriological Sampling from the Root Canal System and Outer Root Surface Genomic DNA Isolation and Measurement of DNA Concentration PCR (16S Universal primer) Purification and sequencing of the 16S rRNA gene Power Analysis and Sample Size Calculations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| apical periodontitis | Experimental | Other: apical periodontitis60 patients with AP and extraction indication (due to restorative causes and lesion size) were included in the study |
| control | Experimental | Other: apical periodontitisA total of 30 volunteers who were determined to be systemically and orally healthy (not having AP indication), were included in the study as the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- AP and extraction indication (due to restorative causes and lesion size) were included in the study
Key exclusion criteria (1 listed)
- Patients who had any acute or chronic inflammatory disease, known infection status, history of trauma or surgical operation within 6 months that may affect MMP-9 levels, pregnant and/or lactating, malignity, morbid obesity, arthritis, immunologic diseases, cardiovascular diseases or use of vitamins with high biotin were not included in the study. Additionally, patients who used antibiotics or anti-inflammatory drugs within the last 6 months, and patients with periodontal disease were excluded from the study.
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 |
|---|---|---|
| apical periodontitisOf these patients, 60 patients with AP and extraction indication (due to restorative causes and lesion size) were included in the study | Other | apical periodontitis, control |
Primary outcome
Laboratory Analysis
Time frame: The study was conducted between March 2022 and February 2023
Blood samples were collected from the patients for MMP-9 and TNF-α analysis. The blood samples taken from the patients in a tube with a gel separator were kept at room temperature for 20-30 minutes to coagulate, and then centrifuged at 1800 g for 10 minutes. T
2 secondary outcomes
Bacteriological Sampling from the Root Canal System and Outer Root Surface
Time frame: The study was conducted between March 2022 and February 2023
ELISA measurement procedure of MMP-9 and TNF-α levels
Time frame: The study was conducted between March 2022 and February 2023
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 12 May 2023.
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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.
Seyda Ersahan, Assoc.Prof. principal investigator
IstanbulMedipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing apical periodontitis in people with Periapical Periodontitis and MMP-9, run by Seyda Ersahan, DDS, PhD 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 1 inclusion and 1 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 12 May 2023. 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?
Laboratory Analysis (time frame: The study was conducted between March 2022 and February 2023). 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 12 May 2023.