PeriodontitisNCT05722613
Diagnostic Potential of the Salivary Biomarkers to Differentiate Statuses of Periodontitis
An observational study of Periodontitis, run by University of Baghdad at 1 site in Iraq.
Trial summary
Periodontitis is a chronic inflammatory disease characterized by both dysbiosis of oral microbiota and proinflammatory events involving both cells and mediators from innate and adaptive immunity. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- How many people
- 120 participants
- Where
- 1 siteIraq
- Study dates
- 1 May 2022to 1 Jun 2023
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients will be recruited from the Department of Periodontics, College of Dentistry, University of Baghdad.
Who may be able to join
- Male and female systemically healthy patients.
- Body mass index ≤ 30.
- Have a minimum of 20 teeth with facial and lingual scorable surfaces.
- Clinical criteria for periodontal health and periodontitis will be as follows :
- 1. Healthy periodontium (Group A): BOP <10%, PPD ≤ 3mm, intact periodontium (no probing attachment loss).
- 2. Periodontitis groups are defined as : i. Interdental CAL is detectable at ≥2 non-adjacent teeth, or ii. Buccal or oral CAL ≥3 mm with pocketing >3mm is detectable at ≥2teeth
Who cannot join
- Patients who refused to participate in the study.
- Individuals with dental implants.
- Previous history of extensive periodontal therapy preceding 6 months or currently under active periodontal treatment.
- Patients receiving antibiotic treatment or immunosuppressant medication within the last 3 months
- Pregnant or lactating mothers.
- Any symptoms of recent acute illness, e.g., COVID-19.
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- Tobacco use.
- Active orthodontic therapy
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Potential of the Salivary (miRNAs - 146-a, 186, IL-1ß, and IL- 10) to Differentiate Statuses of Periodontitis: A Case-Control Study
Periodontitis is a chronic inflammatory disease characterized by both dysbiosis of oral microbiota and proinflammatory events involving both cells and mediators from innate and adaptive immunity. These events lead to chronic inflammation of periodontal soft and hard tissues sharing many features with other chronic inflammatory diseases. These events lead to chronic inflammation of periodontal soft and hard tissues sharing many features with other chronic inflammatory diseases. Chronic inflammation is driven by various mediators, of which a significant part is attributed to the interactions within cytokine networks. While proinflammatory cytokines, including interleukin (IL) -1α, IL-1β, TNF-α, IL-6, and IL-17, contribute to acute and chronic inflammation and tissue injury, a second group with antagonist effects is formed by cytokines such as IL-10
Read the detailed description
Diagnosis of Periodontitis represents the backbone of a successful periodontal treatment since the entire treatment plan, prognosis, and maintenance directly depend on the quality and precision of periodontal diagnosis. Since periodontal diagnostics is still based on clinical and radiological parameters providing limited therapeutic guidance, biomarkers have been introduced for the first time within the new classification of periodontal and peri-implant conditions as a first step towards the adoption of precision medicine concepts in periodontology. Saliva, as part of oral fluids, is an optimal biological fluid that contains locally and systemically derived mediators of periodontal disease (proteins, genetic/genomic biomarkers such as DNA and mRNA, and various metabolites that originate from the host and the bacteria) to serve as the diagnostic tool for periodontitis. The collection of saliva is safe, non-invasive, and simple, and saliva can be collected repeatedly with minimum discomfort to the patient. Single biomarker detection may not be effective enough for accurate diagnoses without false-positive or false-negative results. Periodontitis is a disease that involves complex interactions between bacteria and the host immune system. The combination of the host and bacteria-derived biomarkers, which reflect inflammation, soft tissue destruction, and bone destruction together, may be helpful in the diagnosis
- Conditions
- Periodontitis
- Keywords
- periodontitis, saliva, case control
- Medical subject headings
- Periodontitis
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 |
|---|---|---|
| (Group A) periodontally healthy as a control | BOP <10%, PPD ≤ 3mm, intact periodontium (no probing attachment loss). | |
| (Group B) periodontitis currently unstable | Generalized periodontitis, currently unstable (PPD ≥ 5mm or PPD at ≥ 4mm with BOP). | |
| (Group C)periodontitis currently stable . | Generalized periodontitis, currently stable (BOP < 10 % PPD ≤4 mm and no BOP at 4mm sites) |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis
The primary outcomes will be determining salivary levels of (miRNAs 146-a, 186, IL-1β, and IL-10
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 May 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Jalil Raheem, University of Baghdad
- Investigators
- zainab J Raheem, MSc, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722613
- Sponsor's protocol ID
- 527622
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Raheem ZJ, Abdulbaqi HR. Diagnostic Potential of Salivary Interleukin-1beta and IL-10 for Distinguishing Periodontal Health From Periodontitis and Stable From Unstable Periodontitis: A Case-Control Study. Int J Dent. 2024 Oct 15;2024:8006278. doi: 10.1155/2024/8006278. eCollection 2024.
PubMed 39445112
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Potential of the Salivary (miRNAs - 146-a, 186, IL-1ß, and IL- 10) to Differentiate Statuses of Periodontitis: A Case-Control Study
- ClinicalTrials.gov ID
- NCT05722613
- Acronym / sponsor ID
- 527622
- Conditions
- Periodontitis
- Keywords
- periodontitis, saliva, case control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 10 Feb 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.
Periodontitis is a chronic inflammatory disease characterized by both dysbiosis of oral microbiota and proinflammatory events involving both cells and mediators from innate and adaptive immunity. These events lead to chronic inflammation of periodontal soft and hard tissues sharing many features with other chronic inflammatory diseases. These events lead to chronic inflammation of periodontal soft and hard tissues sharing many features with other chronic inflammatory diseases. Chronic inflammation is driven by various mediators, of which a significant part is attributed to the interactions within cytokine networks. While proinflammatory cytokines, including interleukin (IL) -1α, IL-1β, TNF-α, IL-6, and IL-17, contribute to acute and chronic inflammation and tissue injury, a second group with antagonist effects is formed by cytokines such as IL-10
Detailed description
Diagnosis of Periodontitis represents the backbone of a successful periodontal treatment since the entire treatment plan, prognosis, and maintenance directly depend on the quality and precision of periodontal diagnosis. Since periodontal diagnostics is still based on clinical and radiological parameters providing limited therapeutic guidance, biomarkers have been introduced for the first time within the new classification of periodontal and peri-implant conditions as a first step towards the adoption of precision medicine concepts in periodontology. Saliva, as part of oral fluids, is an optimal biological fluid that contains locally and systemically derived mediators of periodontal disease (proteins, genetic/genomic biomarkers such as DNA and mRNA, and various metabolites that originate from the host and the bacteria) to serve as the diagnostic tool for periodontitis. The collection of saliva is safe, non-invasive, and simple, and saliva can be collected repeatedly with minimum discomfort to the patient. Single biomarker detection may not be effective enough for accurate diagnoses without false-positive or false-negative results. Periodontitis is a disease that involves complex interactions between bacteria and the host immune system. The combination of the host and bacteria-derived biomarkers, which reflect inflammation, soft tissue destruction, and bone destruction together, may be helpful in the diagnosis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| (Group A) periodontally healthy as a control | – | –BOP <10%, PPD ≤ 3mm, intact periodontium (no probing attachment loss). |
| (Group B) periodontitis currently unstable | – | –Generalized periodontitis, currently unstable (PPD ≥ 5mm or PPD at ≥ 4mm with BOP). |
| (Group C)periodontitis currently stable . | – | –Generalized periodontitis, currently stable (BOP < 10 % PPD ≤4 mm and no BOP at 4mm sites) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be recruited from the Department of Periodontics, College of Dentistry, University of Baghdad.
Key inclusion criteria (6 listed)
- Male and female systemically healthy patients.
- Body mass index ≤ 30.
- Have a minimum of 20 teeth with facial and lingual scorable surfaces.
- Clinical criteria for periodontal health and periodontitis will be as follows :
- 1. Healthy periodontium (Group A): BOP <10%, PPD ≤ 3mm, intact periodontium (no probing attachment loss).
Key exclusion criteria (9 listed)
- Patients who refused to participate in the study.
- Individuals with dental implants.
- Previous history of extensive periodontal therapy preceding 6 months or currently under active periodontal treatment.
- Patients receiving antibiotic treatment or immunosuppressant medication within the last 3 months
- Pregnant or lactating mothers.
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
diagnosis
Time frame: base line
The primary outcomes will be determining salivary levels of (miRNAs 146-a, 186, IL-1β, and IL-10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Derived from this study: PubMed 39445112Raheem ZJ, Abdulbaqi HR. Diagnostic Potential of Salivary Interleukin-1beta and IL-10 for Distinguishing Periodontal Health From Periodontitis and Stable From Unstable Periodontitis: A Case-Control Study. Int J Dent. 2024 Oct 15;2024:8006278. doi: 10.1155/2024/8006278. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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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.
zainab J Raheem, MSc principal investigator
University of Baghdad
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 Periodontitis, run by University of Baghdad at 1 site in Iraq.
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 6 inclusion and 9 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 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 Iraq. 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?
Results are not available in the source record.
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?
diagnosis (time frame: base line). 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 NCT05722613, which also lists 1 linked publication.
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 2023.