Apical PeriodontitisNCT04824209
Serum Pro-Diabetes Inflammation Biomarkers in Patients With Apical Periodontitis.
An observational study of Apical Periodontitis and Insulin Resistance, run by University of Turin, Italy at 2 sites in Italy.
Trial summary
Inflammation is a common factor of chronic periodontitis and diabetes. However, to date, there is no scientific evidence supporting a causal effect of the inflammation created by apical periodontitis on the onset of insulin resistance and on metabolic derangement in the condition of pre-diabetes or diabetes. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Insulin Resistance, PreDiabetes
- How many people
- 27 participants
- Where
- 2 sitesItaly
- Study dates
- 9 Feb 2021to 25 Apr 2023
- How long will I take part?
- 12 Months
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Dental Hospital
Who may be able to join
- 25-55 years, healthy
Who cannot join
- under 25 years, over 55 years, patients with systemic or oral diseases or patients who underwent other dental treatments in the previous 6 months
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Department of Oncology - University of Turin
Turin, 10126
Endodontics, Department of Surgical Sciences - Univeristy of Turin
Turin, 10126
About this study
Official title: Evaluation of Serum Markers of Pro-diabetes Inflammation in Patients With Chronic Apical Periodontitis Before and After Endodontic Treatment.
Inflammation is a common factor of chronic periodontitis and diabetes. However, to date, there is no scientific evidence supporting a causal effect of the inflammation created by apical periodontitis on the onset of insulin resistance and on metabolic derangement in the condition of pre-diabetes or diabetes.
A case control study has been designed in order to evaluate serum levels of pro-diabetes inflammation factors in a sample of healthy patients between 25 and 55 years of age, with or without apical periodontitis,before endodontic treatment and at 6 and 12 months post-treatment. The aim of the study is to evaluate any relation between the presence of chronic endodontic lesions and pro-diabetes inflammation factors that can promote the onset of insulin resistance, and whether endodontic treatment can reduce these factors, thus preventing a pro-diabetes status.
Read the detailed description
Healthy, consenting and informed patients of both gender under 55 years of age with apical periodontitis will be enrolled as cases. Healthy, consenting and informed patients of both gender under 55 years of age without apical periodontitis will be enrolled as control subjects. The study has been designed to assess the serum level of TNF-α, IL-1β, IL-6, IL-8 by ELISA assay.
- Keywords
- Endodontics, Apical Periodontitis, Insulin Resistance, Diabetes, Pro-Diabetes Inflammation Markers
- Medical subject headings
- Periapical Periodontitis, Insulin Resistance, Prediabetic State, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AP group | Healthy patients between 25-55 years with Apical Periodontitis | |
| Control Group | Healthy patients between 25-55 years without Apical Periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
Dosage of TNF-α, IL-1β, IL-6, IL-8 (pg/mL) in serum(ng/10^6 platelets) by ELISA assay.
Measured: Baseline serum levels of selected pro-diabetes inflammation markers in control group and AP group.
Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
Dosage of TNF-α, IL-1β, IL-6, IL-8 (pg/mL) in serum by ELISA assay.
Measured: Serum levels of selected pro-diabetes inflammation markers at 6 months after endodontic treatment and in control group.
Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
Dosage of TNF-α, IL-1β, IL-6, IL-8 (pg/mL) in serum by ELISA assay.
Measured: Serum levels of selected pro-diabetes inflammation markers at 12 months after endodontic treatment and in control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start9 Feb 2021
- Primary completion30 Apr 2022
- Study completion25 Apr 2023
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
- 27 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damiano Pasqualini, DDS Ass Pro, Principal investigator, Endodontics, Department of Surgical Sciences - Univeristy of Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824209
- Sponsor's protocol ID
- 0094485
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2021
- Last updated
- 28 Apr 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 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Markers of Pro-diabetes Inflammation in Patients With Chronic Apical Periodontitis Before and After Endodontic Treatment.
- ClinicalTrials.gov ID
- NCT04824209
- Acronym / sponsor ID
- 0094485
- Keywords
- Endodontics, Apical Periodontitis, Insulin Resistance, Diabetes, Pro-Diabetes Inflammation Markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 1 Apr 2021 (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.
Inflammation is a common factor of chronic periodontitis and diabetes. However, to date, there is no scientific evidence supporting a causal effect of the inflammation created by apical periodontitis on the onset of insulin resistance and on metabolic derangement in the condition of pre-diabetes or diabetes.
A case control study has been designed in order to evaluate serum levels of pro-diabetes inflammation factors in a sample of healthy patients between 25 and 55 years of age, with or without apical periodontitis,before endodontic treatment and at 6 and 12 months post-treatment. The aim of the study is to evaluate any relation between the presence of chronic endodontic lesions and pro-diabetes inflammation factors that can promote the onset of insulin resistance, and whether endodontic treatment can reduce these factors, thus preventing a pro-diabetes status.
Detailed description
Healthy, consenting and informed patients of both gender under 55 years of age with apical periodontitis will be enrolled as cases. Healthy, consenting and informed patients of both gender under 55 years of age without apical periodontitis will be enrolled as control subjects. The study has been designed to assess the serum level of TNF-α, IL-1β, IL-6, IL-8 by ELISA assay.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP group | – | –Healthy patients between 25-55 years with Apical Periodontitis |
| Control Group | – | –Healthy patients between 25-55 years without Apical Periodontitis |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Dental Hospital
Key inclusion criteria (1 listed)
- 25-55 years, healthy
Key exclusion criteria (1 listed)
- under 25 years, over 55 years, patients with systemic or oral diseases or patients who underwent other dental treatments in the previous 6 months
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
Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
Time frame: Baseline serum levels of selected pro-diabetes inflammation markers in control group and AP group.
Dosage of TNF-α, IL-1β, IL-6, IL-8 (pg/mL) in serum(ng/10^6 platelets) by ELISA assay.
Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
Time frame: Serum levels of selected pro-diabetes inflammation markers at 6 months after endodontic treatment and in control group.
Dosage of TNF-α, IL-1β, IL-6, IL-8 (pg/mL) in serum by ELISA assay.
Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
Time frame: Serum levels of selected pro-diabetes inflammation markers at 12 months after endodontic treatment and in control group.
Dosage of TNF-α, IL-1β, IL-6, IL-8 (pg/mL) in serum by ELISA assay.
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 28 Apr 2023.
Related trials for Apical Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
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.
Damiano Pasqualini, DDS Ass Pro principal investigator
Endodontics, Department of Surgical Sciences - Univeristy of Turin
2 sites 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 and Insulin Resistance, run by University of Turin, Italy at 2 sites in Italy.
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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Variation in pro-diabetes inflammation markers over time upon endodontic intervention. (time frame: Baseline serum levels of selected pro-diabetes inflammation markers in control group and AP group.). 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?
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 28 Apr 2023.