Apical PeriodontitisNCT06512103
Sclerostin Regulation in Apical Periodontitis Lesions in Apical Periodontitis Lesions
An observational study of Apical Periodontitis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Our aim was to examine the relationship between inflammatory bone resorption associated with the severity of AP and gingival crevicular fluid (GCF) and blood sclerostin and PGE2 levels in cases 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
- Apical Periodontitis
- What is being tested?
- Apical periodontitis group
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 31 Jan 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study included 90 patients diagnosed with chronic apical periodontitis. 35 healthy volunteers who came to the dental clinic for check-up and periodic examination and did not have periodontal pathology, any acute/chronic disease.
Who may be able to join
- patients with chronic apical periodontitis having no periodontal pathology having no acute/chronic disease (muscle-joint-bone diseases, inflammatory bowel disease, local or generalized infection, severe organ disease, cardiovascular disease and diabetes mellitus)
Who cannot join
- Patients who had any acute/chronic disease (inflammatory and rheumatoid diseases, cardiovascular disease, muscle-joint-bone diseases, inflammatory bowel disease, local or generalized infection, connective tissue diseases and diabetes mellitus) patients who had a history of smoking pregnant and/or lactating patients antibiotics or anti-inflammatory drugs use within the last 6 months patients undergoing dental treatment having chronic marginal periodontitis along with AP patients with a history of using immunosuppressive drugs, steroid or nonsteroidal anti-inflammatory drugs use of high doses of biotin vitamin in the last 48 hours
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, Faculty of Dentistry
Istanbul
About this study
Official title: Relationship Between Bone Resorption and Sclerostin Regulation in Apical Periodontitis Lesions
Our aim was to examine the relationship between inflammatory bone resorption associated with the severity of AP and gingival crevicular fluid (GCF) and blood sclerostin and PGE2 levels in cases of AP. Additionally, the correlation of sclerostin regulation with RANKL and MMP-9 levels will be investigated.This single-centered cross-sectional analytical study included 90 patients with AP and 35 systemically and orally healthy volunteers as the control group, who applied for a control examination between September 2023 and February 2024. Demographic characteristics of the patients (age, body mass index (BMI) and oral hygiene index (OHI)) and dental examination findings (periapical index (PAI) score, root canal treatment, number of crowns, fillings and missing teeth, etc.) were recorded. According to the PAI score, the participants were divided into three groups: 35 healthy patients with a PAI score of 1-2 (Group 1: Control group), 35 patients with a PAI score of 3-4 (Group 2: mild-moderate AP), and 55 patients having at least one tooth with PAI score of 5, characterized by more severe bone resorption (Group 3: Severe AP). Sclerostin, RANKL and MMP-9 levels were measured in serum and GCF of all participants.
Read the detailed description
Fasting (8-10 hours) venous blood of all participants was taken from forearm antecubital/basic veins. After keeping the blood at room temperature for 30 minutes, it was centrifuged at 2500 xg for 10 minutes. After centrifugation, the upper serum of the tubes was separated. Hemolysis index (HI) of the sera were measured to prevent optical interference in the biochemistry autoanalyzer device (Cobas 8000 Chemistry Analyzer, USA). Samples with a hemolysis index greater than 50 mg/dl Hb were excluded from the study. The sera obtained after centrifugation were aliquoted into 0.5 mL tubes (Eppendorf, Hamburg, Germany) and stored at - 80 °C until the day of analysis.
GCF samples were taken prior to periodontal probing to avoid contamination by blood. To avoid contamination of the sample, patients were asked not to eat or drink anything for at least 30 minutes before the procedure. After selecting the area where GCF collection would be made (the area of the tooth with AP and the area that often corresponds to the same area in healthy individuals), the sampling area was isolated with cotton rolls, and plaque was removed. After gentle air-drying, PerioPaper strips (OraFlow Inc., NY, USA) were placed gently until slight resistance was felt and left there for 30 seconds. Three samples were taken from the mesial, distal and buccal surfaces of related tooth. Periopapers were thoroughly washed in 0.5 ml Eppendorf tubes (after subtracting the tare weight of the tube) with 100 µl of phosphate-buffered saline (PBS) using an automatic pipette. Blood-stained paper strips were removed from the samples. All GCF samples were weighed on a precision balance (Shimadzu Libror, Model AEG-220, Germany) and recorded. The samples in all closed tubes were mixed thoroughly with a vortex device (Heidolph Reax Top Vortex, Schwabach, Germany) for approximately 15-20 seconds. This allowed GCF to pass into PBS. Periopapers in tubes were removed from GCF and PBS without contamination. The remaining extract in tubes was stored at -80oC until the day of analysis. The results obtained on the study day were proportioned by weighing weights/PBS. On the day of analysis, all serums and GCF were first allowed to dissolve slowly at +4 oC and then brought to room temperature before measurement.
- Conditions
- Apical Periodontitis
- Being tested
- Apical periodontitis group
- Keywords
- Apical periodontitis, Bone resorption, Gingival crevicular fluid, Sklerostin, PGE2
- Medical subject headings
- Periapical Periodontitis, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apical periodontitis groupDiagnostic test
Also called Control group
Radiography of the patients were taken. Blood samples and gingival crevicular fluid samples were collected from those patient
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 90 patients with apical periodontitis (AP group) | AP group was divided into 3 subgroups. The participants in the study group were divided into two subgroups: 35 patients with a PAI score of 3-4 (Group 2: mild-moderate AP), and 55 patients with at least one tooth with a severity of PAI 5 (Group 3: Severe AP). Receives: Diagnostic Test: Apical periodontitis group | |
| Control: A healthy control group of 35 volunteers | A healthy control group of 35 volunteers without periodontal pathology as well as any acute/chronic disease (muscle-joint-bone diseases, inflammatory bowel disease, local or generalized infection, severe organ disease, cardiovascular disease and diabetes mellitus), were included in the control group. 35 healthy patients with a PAI score of 1-2 (Group 1: Control group) were included. Receives: Diagnostic Test: Apical periodontitis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of sclerostin, RANKL, MMP-9 and PGE2 in gingival crevicular fluid
correlation between periapical radiolucency and GCF levels will be evaluated
Measured: baseline
Secondary outcomes (1)
levels of sclerostin, RANKL, MMP-9 and PGE2 in serum
correlation between periapical radiolucency and serum levels will be evaluated
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Aug 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda Ersahan, DDS, PhD, Istanbul Medipol University Hospital
- Investigators
- Ebru Uysal, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512103
- Sponsor's protocol ID
- 623
- Status last verified
- Jul 2024
- First submitted
- 16 May 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request from corresponding author, we can share our data
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Bone Resorption and Sclerostin Regulation in Apical Periodontitis Lesions
- ClinicalTrials.gov ID
- NCT06512103
- Acronym / sponsor ID
- 623
- Conditions
- Apical Periodontitis
- Keywords
- Apical periodontitis, Bone resorption, Gingival crevicular fluid, Sklerostin, PGE2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 22 Jul 2024 (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.
Our aim was to examine the relationship between inflammatory bone resorption associated with the severity of AP and gingival crevicular fluid (GCF) and blood sclerostin and PGE2 levels in cases of AP. Additionally, the correlation of sclerostin regulation with RANKL and MMP-9 levels will be investigated.This single-centered cross-sectional analytical study included 90 patients with AP and 35 systemically and orally healthy volunteers as the control group, who applied for a control examination between September 2023 and February 2024. Demographic characteristics of the patients (age, body mass index (BMI) and oral hygiene index (OHI)) and dental examination findings (periapical index (PAI) score, root canal treatment, number of crowns, fillings and missing teeth, etc.) were recorded. According to the PAI score, the participants were divided into three groups: 35 healthy patients with a PAI score of 1-2 (Group 1: Control group), 35 patients with a PAI score of 3-4 (Group 2: mild-moderate AP), and 55 patients having at least one tooth with PAI score of 5, characterized by more severe bone resorption (Group 3: Severe AP). Sclerostin, RANKL and MMP-9 levels were measured in serum and GCF of all participants.
Detailed description
Fasting (8-10 hours) venous blood of all participants was taken from forearm antecubital/basic veins. After keeping the blood at room temperature for 30 minutes, it was centrifuged at 2500 xg for 10 minutes. After centrifugation, the upper serum of the tubes was separated. Hemolysis index (HI) of the sera were measured to prevent optical interference in the biochemistry autoanalyzer device (Cobas 8000 Chemistry Analyzer, USA). Samples with a hemolysis index greater than 50 mg/dl Hb were excluded from the study. The sera obtained after centrifugation were aliquoted into 0.5 mL tubes (Eppendorf, Hamburg, Germany) and stored at - 80 °C until the day of analysis.
GCF samples were taken prior to periodontal probing to avoid contamination by blood. To avoid contamination of the sample, patients were asked not to eat or drink anything for at least 30 minutes before the procedure. After selecting the area where GCF collection would be made (the area of the tooth with AP and the area that often corresponds to the same area in healthy individuals), the sampling area was isolated with cotton rolls, and plaque was removed. After gentle air-drying, PerioPaper strips (OraFlow Inc., NY, USA) were placed gently until slight resistance was felt and left there for 30 seconds. Three samples were taken from the mesial, distal and buccal surfaces of related tooth. Periopapers were thoroughly washed in 0.5 ml Eppendorf tubes (after subtracting the tare weight of the tube) with 100 µl of phosphate-buffered saline (PBS) using an automatic pipette. Blood-stained paper strips were removed from the samples. All GCF samples were weighed on a precision balance (Shimadzu Libror, Model AEG-220, Germany) and recorded. The samples in all closed tubes were mixed thoroughly with a vortex device (Heidolph Reax Top Vortex, Schwabach, Germany) for approximately 15-20 seconds. This allowed GCF to pass into PBS. Periopapers in tubes were removed from GCF and PBS without contamination. The remaining extract in tubes was stored at -80oC until the day of analysis. The results obtained on the study day were proportioned by weighing weights/PBS. On the day of analysis, all serums and GCF were first allowed to dissolve slowly at +4 oC and then brought to room temperature before measurement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: 90 patients with apical periodontitis (AP group) | – | Diagnostic Test: Apical periodontitis groupAP group was divided into 3 subgroups. The participants in the study group were divided into two subgroups: 35 patients with a PAI score of 3-4 (Group 2: mild-moderate AP), and 55 patients with at least one tooth with a severity of PAI 5 (Group 3: Severe AP). |
| Control: A healthy control group of 35 volunteers | – | Diagnostic Test: Apical periodontitis groupA healthy control group of 35 volunteers without periodontal pathology as well as any acute/chronic disease (muscle-joint-bone diseases, inflammatory bowel disease, local or generalized infection, severe organ disease, cardiovascular disease and diabetes mellitus), were included in the control group. 35 healthy patients with a PAI score of 1-2 (Group 1: Control group) were included. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study included 90 patients diagnosed with chronic apical periodontitis. 35 healthy volunteers who came to the dental clinic for check-up and periodic examination and did not have periodontal pathology, any acute/chronic disease.
Key inclusion criteria (1 listed)
- patients with chronic apical periodontitis having no periodontal pathology having no acute/chronic disease (muscle-joint-bone diseases, inflammatory bowel disease, local or generalized infection, severe organ disease, cardiovascular disease and diabetes mellitus)
Key exclusion criteria (1 listed)
- Patients who had any acute/chronic disease (inflammatory and rheumatoid diseases, cardiovascular disease, muscle-joint-bone diseases, inflammatory bowel disease, local or generalized infection, connective tissue diseases and diabetes mellitus) patients who had a history of smoking pregnant and/or lactating patients antibiotics or anti-inflammatory drugs use within the last 6 months patients undergoing dental treatment having chronic marginal periodontitis along with AP patients with a history of using immunosuppressive drugs, steroid or nonsteroidal anti-inflammatory drugs use of high doses of biotin vitamin in the last 48 hours
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 periodontitis groupAlso: Control groupRadiography of the patients were taken. Blood samples and gingival crevicular fluid samples were collected from those patient | Diagnostic test | Control: A healthy control group of 35 volunteers, Experimental: 90 patients with apical periodontitis (AP group) |
Primary outcome
levels of sclerostin, RANKL, MMP-9 and PGE2 in gingival crevicular fluid
Time frame: baseline
correlation between periapical radiolucency and GCF levels will be evaluated
1 secondary outcome
levels of sclerostin, RANKL, MMP-9 and PGE2 in serum
Time frame: baseline
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 3 Oct 2024.
- Individual participant dataSharing planned: Undecided. Upon request from corresponding author, we can share our data
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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.
Ebru Uysal, PhD principal investigator
Medipol University
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 Apical Periodontitis, run by Istanbul Medipol University Hospital 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 3 Oct 2024. 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?
levels of sclerostin, RANKL, MMP-9 and PGE2 in gingival crevicular fluid (time frame: baseline). 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 3 Oct 2024.