Apical PeriodontitisNCT05232591
Evaluation of IL-17, TNF-alpha, RANKL Levels in Gingival Cervicular Fluid
An observational study of Apical Periodontitis, run by Yuzuncu Yil University.
Trial summary
Inflammatory process begins around root apex as a result of bacterial infection of pulp cavity in chronic apical periodontitis. Bone destruction can begin in apical region after immunological reactions at the end of inflammatory process, and radiolucent periapical lesion seems in this way. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- The teeth diagnosed with chronic apical periodontitis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 30 Apr 2022
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: It is planned to include volunteer patients who came to Van YYU Faculty of Dentistry, Oral and Maxillofacial Radiology Department for routine examination.
Who may be able to join
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis and periapical lesion
Who cannot join
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
- Teeth with immature/open apex
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of IL-17, TNF-alpha, RANKL Levels in Gingival Cervicular Fluid of Teeth With Periapical Lesions Diagnosed With Chronic Apical Periodontitis
Inflammatory process begins around root apex as a result of bacterial infection of pulp cavity in chronic apical periodontitis. Bone destruction can begin in apical region after immunological reactions at the end of inflammatory process, and radiolucent periapical lesion seems in this way. If bone destruction around apical region is in the rate of 30%, we can notice this difference eventually. Histological manifestations of periapical inflammation can be observed in the result of pulp necrosis and inflammation around apical region. Mocelular methods can determine the type of therapy in various diseases. Each region and tissue reserve specific host factors. Vast majority of pulpal inflammation was trigerred by microorganisms. Certain bacterial virulence factors may damage host tissue directly, other virulence factors can stimulate prolonged non-specific immune response causing tissue damage. In the last phase of infection, immunopathological destruction of pulp tissue is observed due to humoral response. IL-17 is an important inflammatory cytokine released from T cells of the immune system. TNF-alpha and RANKL are also mediators responsible for bone destruction metabolism. TNF is a cytokine mediating immunologic changes during periodontal disease. TNF induction stimulate secondary mediators taking part as chemotactic cytokines. TNF has two different types; TNF-alpha and TNF-beta. TNF-alpha is a polypeptide cytokine produced by macrophages and monocytes. TNF-alpha stimulates bone resorption . There has been limited researches analyzing GCF, blood and tissue of pulp, dentin-derived fluid and periapical fluid for molecular diagnosis so far. GCF is a fluid derived from gingival groove. This fluid contains a lot of host factors such as anticor, bacterial antigen, protein and cytokines. GCF sampling is a non-invasive method, it can be used to provide diagnostic information in all clinical cases. In this study, we will evaluate the levels of IL-17, TNF-alpha and RANKL in the gingival crevicular fluid of teeth with periapical lesion diagnosed with chronic apical periodontitis. Thus, it will be evaluated whether these markers can be used for diagnosis and follow-up of the disease in teeth with periapical lesions.
Read the detailed description
It is planned to include volunteer patients who came to Van YYU Faculty of Dentistry, Oral and Maxillofacial Radiology Department between February and March 2022 for routine examination. Patients who applied to Yüzüncü Yıl University Faculty of Dentistry for treatment and met the study criteria will be included in the study by signing an informed consent form. 40 patients diagnosed with chronic apical periodontitis and having teeth with radiographic periapical lesions will be included in the study. Patients with periodontitis will not be included in the study.
GCF samples will be taken from the teeth diagnosed with chronic apical periodontitis and the contralateral teeth (from healthy teeth). The tooth which is resource of GCF will be isolated with cotton pellets. After the supragingival plaque is carefully removed with a curette, the tooth will be air-dried for 10 seconds, and periopaper strips will be placed in the gingival sulcus until resistance is felt. Periopaper strips will be removed from the gilgival sulcus after 1 minute. The levels of IL-17, TNF-alpha and RANKL from the samples in the gingival crevicular fluid will be evaluated.
- Conditions
- Apical Periodontitis
- Being tested
- The teeth diagnosed with chronic apical periodontitis
- Keywords
- Gingival cervicular fluid, IL-17, TNF-alpha, RANKL
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The teeth diagnosed with chronic apical periodontitisDiagnostic test
GCF samples will be taken from the teeth diagnosed with chronic apical periodontitis
| Study group | Role | What they receive |
|---|---|---|
| 1 | GCF samples will be taken from the teeth diagnosed with chronic apical periodontitis Receives: Diagnostic Test: The teeth diagnosed with chronic apical periodontitis | |
| 2 | GCF samples will be taken from the collateral teeth (healthy teeth) of the teeth diagnosed with chronic apical periodontitis. Receives: Diagnostic Test: The teeth diagnosed with chronic apical periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-17 Level
Concentration of IL-17 in GCF
Measured: 6 months
TNF-alpha
Concentration of TNF-alpha in GCF
Measured: 6 months
RANKL
Concentration of RANKL in GCF
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 posted10 Feb 2022
- Study start1 Feb 2022 (estimated)
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Apical 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Özlek, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232591
- Sponsor's protocol ID
- 2021/08-02
- Status last verified
- Feb 2022
- First submitted
- 17 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Newton CW, Hoen MM, Goodis HE, Johnson BR, McClanahan SB. Identify and determine the metrics, hierarchy, and predictive value of all the parameters and/or methods used during endodontic diagnosis. J Endod. 2009 Dec;35(12):1635-44. doi: 10.1016/j.joen.2009.09.033.
PubMed 19932338Ricucci D, Siqueira JF Jr, Bate AL, Pitt Ford TR. Histologic investigation of root canal-treated teeth with apical periodontitis: a retrospective study from twenty-four patients. J Endod. 2009 Apr;35(4):493-502. doi: 10.1016/j.joen.2008.12.014.
PubMed 19345793
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of IL-17, TNF-alpha, RANKL Levels in Gingival Cervicular Fluid of Teeth With Periapical Lesions Diagnosed With Chronic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT05232591
- Acronym / sponsor ID
- 2021/08-02
- Conditions
- Apical Periodontitis
- Keywords
- Gingival cervicular fluid, IL-17, TNF-alpha, RANKL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 10 Feb 2022 (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.
Inflammatory process begins around root apex as a result of bacterial infection of pulp cavity in chronic apical periodontitis. Bone destruction can begin in apical region after immunological reactions at the end of inflammatory process, and radiolucent periapical lesion seems in this way. If bone destruction around apical region is in the rate of 30%, we can notice this difference eventually. Histological manifestations of periapical inflammation can be observed in the result of pulp necrosis and inflammation around apical region. Mocelular methods can determine the type of therapy in various diseases. Each region and tissue reserve specific host factors. Vast majority of pulpal inflammation was trigerred by microorganisms. Certain bacterial virulence factors may damage host tissue directly, other virulence factors can stimulate prolonged non-specific immune response causing tissue damage. In the last phase of infection, immunopathological destruction of pulp tissue is observed due to humoral response. IL-17 is an important inflammatory cytokine released from T cells of the immune system. TNF-alpha and RANKL are also mediators responsible for bone destruction metabolism. TNF is a cytokine mediating immunologic changes during periodontal disease. TNF induction stimulate secondary mediators taking part as chemotactic cytokines. TNF has two different types; TNF-alpha and TNF-beta. TNF-alpha is a polypeptide cytokine produced by macrophages and monocytes. TNF-alpha stimulates bone resorption . There has been limited researches analyzing GCF, blood and tissue of pulp, dentin-derived fluid and periapical fluid for molecular diagnosis so far. GCF is a fluid derived from gingival groove. This fluid contains a lot of host factors such as anticor, bacterial antigen, protein and cytokines. GCF sampling is a non-invasive method, it can be used to provide diagnostic information in all clinical cases. In this study, we will evaluate the levels of IL-17, TNF-alpha and RANKL in the gingival crevicular fluid of teeth with periapical lesion diagnosed with chronic apical periodontitis. Thus, it will be evaluated whether these markers can be used for diagnosis and follow-up of the disease in teeth with periapical lesions.
Detailed description
It is planned to include volunteer patients who came to Van YYU Faculty of Dentistry, Oral and Maxillofacial Radiology Department between February and March 2022 for routine examination. Patients who applied to Yüzüncü Yıl University Faculty of Dentistry for treatment and met the study criteria will be included in the study by signing an informed consent form. 40 patients diagnosed with chronic apical periodontitis and having teeth with radiographic periapical lesions will be included in the study. Patients with periodontitis will not be included in the study.
GCF samples will be taken from the teeth diagnosed with chronic apical periodontitis and the contralateral teeth (from healthy teeth). The tooth which is resource of GCF will be isolated with cotton pellets. After the supragingival plaque is carefully removed with a curette, the tooth will be air-dried for 10 seconds, and periopaper strips will be placed in the gingival sulcus until resistance is felt. Periopaper strips will be removed from the gilgival sulcus after 1 minute. The levels of IL-17, TNF-alpha and RANKL from the samples in the gingival crevicular fluid will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: The teeth diagnosed with chronic apical periodontitisGCF samples will be taken from the teeth diagnosed with chronic apical periodontitis |
| 2 | – | Diagnostic Test: The teeth diagnosed with chronic apical periodontitisGCF samples will be taken from the collateral teeth (healthy teeth) of the teeth diagnosed with chronic apical periodontitis. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- It is planned to include volunteer patients who came to Van YYU Faculty of Dentistry, Oral and Maxillofacial Radiology Department for routine examination.
Key inclusion criteria (2 listed)
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis and periapical lesion
Key exclusion criteria (6 listed)
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
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 |
|---|---|---|
| The teeth diagnosed with chronic apical periodontitisGCF samples will be taken from the teeth diagnosed with chronic apical periodontitis | Diagnostic test | 1, 2 |
Primary outcome
IL-17 Level
Time frame: 6 months
Concentration of IL-17 in GCF
TNF-alpha
Time frame: 6 months
Concentration of TNF-alpha in GCF
RANKL
Time frame: 6 months
Concentration of RANKL in GCF
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Results publication: PubMed 19932338Newton CW, Hoen MM, Goodis HE, Johnson BR, McClanahan SB. Identify and determine the metrics, hierarchy, and predictive value of all the parameters and/or methods used during endodontic diagnosis. J Endod. 2009 Dec;35(12):1635-44. doi: 10.1016/j.joen.2009.09.033.
- Results publication: PubMed 19345793Ricucci D, Siqueira JF Jr, Bate AL, Pitt Ford TR. Histologic investigation of root canal-treated teeth with apical periodontitis: a retrospective study from twenty-four patients. J Endod. 2009 Apr;35(4):493-502. doi: 10.1016/j.joen.2008.12.014.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Apical Periodontitis, run by Yuzuncu Yil University.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hacer Aydınyurt, PhD (905304589710, hacersahin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-17 Level (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05232591, which also lists 2 linked publications.
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 10 Feb 2022.