Periodontal Disease, AVDC Stage 3and 4NCT05995067
The Potential Association of Long Non-coding RNA (NEAT1 and MALAT1) in the Process of Epithelial-mesenchymal Transition in Periodontitis
An observational study of Periodontal Disease, AVDC Stage 3and 4 and Epithelial Mesenchymal Transition, run by Ali A Abdulkareem at 1 site in Iraq.
Trial summary
Periodontitis is a polymicrobial, inflammatory condition affecting tooth-supporting tissues. It is characterized by a progressive loss of epithelial attachment and resorption of alveolar bone, which can lead to tooth loss. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, AVDC Stage 3and 4, Epithelial Mesenchymal Transition, Long Noncoding RNA
- What is being tested?
- periodontitis challenge
- How many people
- 48 participants
- Where
- 1 siteIraq
- Study dates
- 14 Feb 2022to 30 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients diagnosed with periodontitis, and healthy periodontal tissues will be recruited at the College of Dentistry/University of Baghdad and Al Sadir specialized dental center/Al-Risafa directorate/ Ministry of Health. No age or gender restriction.
Who may be able to join
- Patients with no history of systemic disease e.g., diabetes.
- Both males and females will be included in the study.
- Control group: patients fit the case definition of gingival health2, and confirmed by Histopathological inflammatory cell infiltration analysis.
- Periodontitis group: patients fit the case definition of periodontal disease referred for periodontal flap surgery (modified Widman's flap).
- Patients radiographically confirmed with infrabony pocket eligible for periodontal flap surgery.
Who cannot join
- Patients not willing to participate or consent.
- Patient taking medications that affect or modify immunity (e.g., corticosteroid), for the last 3 months.
- Patient taking NSAIDs for the last 3 months.
- Active smoker.
Trial locations and contacts
1 site in 1 country.
About this study
Periodontitis is a polymicrobial, inflammatory condition affecting tooth-supporting tissues. It is characterized by a progressive loss of epithelial attachment and resorption of alveolar bone, which can lead to tooth loss. Epithelial-mesenchymal transition (EMT) has been proposed as a reversible process that shifts the cell phenotype from epithelial to mesenchymal-like and may be involved in the process of periodontal inflammation either completely or partially. Long non-coding RNAs (lncRNAs) are a large class of regulatory transcripts longer than 200 nucleotides lacking evident protein-coding potential. Studies have shown that lncRNA dysregulation plays key roles in human diseases, including cancer, by modulating the epithelial-mesenchymal transition (EMT). The involvement of lncRNAs markers in the pathogenesis of periodontal disease induced EMT has not been studied thoroughly and have created a gap in the knowledge.
- Conditions
- Periodontal Disease, AVDC Stage 3and 4, Epithelial Mesenchymal Transition, Long Noncoding RNA
- Being tested
- periodontitis challenge
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontitis challengeOther
control will be compared to diseased group suffering from periodontal disease.
| Study group | Role | What they receive |
|---|---|---|
| control group | -healthy groups/without the condition | |
| study group | -diseased group-/with the condition (periodontitis) Receives: Other: periodontitis challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
determining the relative expression of lncRNAs (NEAT1 and MALAT1) in healthy and diseased periodontal tissue.
reverse transcription real time polymerase chain reaction
Measured: one year
Secondary outcomes (1)
determine the expression of EMT-related genes (E-cadherin, Vimentin, β-catenin, and Snail1), in healthy and diseased tissues, and their correlation with lncRNAs and clinical parameters.
reverse transcription real time polymerase chain reaction
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start14 Feb 2022
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Disease, AVDC Stage 3and 4Studies 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
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ali A Abdulkareem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali A Abdulkareem, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995067
- Sponsor's protocol ID
- lncRNA in periodontal disease
- Status last verified
- Dec 2023
- First submitted
- 8 Aug 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Association of Long Non-coding RNA (NEAT1 and MALAT1) in the Process of Epithelial-mesenchymal Transition in Periodontitis
- ClinicalTrials.gov ID
- NCT05995067
- Acronym / sponsor ID
- lncRNA in periodontal disease
- Conditions
- Periodontal Disease, AVDC Stage 3and 4, Epithelial Mesenchymal Transition, Long Noncoding RNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ali A AbdulkareemUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 16 Aug 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 polymicrobial, inflammatory condition affecting tooth-supporting tissues. It is characterized by a progressive loss of epithelial attachment and resorption of alveolar bone, which can lead to tooth loss. Epithelial-mesenchymal transition (EMT) has been proposed as a reversible process that shifts the cell phenotype from epithelial to mesenchymal-like and may be involved in the process of periodontal inflammation either completely or partially. Long non-coding RNAs (lncRNAs) are a large class of regulatory transcripts longer than 200 nucleotides lacking evident protein-coding potential. Studies have shown that lncRNA dysregulation plays key roles in human diseases, including cancer, by modulating the epithelial-mesenchymal transition (EMT). The involvement of lncRNAs markers in the pathogenesis of periodontal disease induced EMT has not been studied thoroughly and have created a gap in the knowledge.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –-healthy groups/without the condition |
| study group | – | Other: periodontitis challenge-diseased group-/with the condition (periodontitis) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with periodontitis, and healthy periodontal tissues will be recruited at the College of Dentistry/University of Baghdad and Al Sadir specialized dental center/Al-Risafa directorate/ Ministry of Health. No age or gender restriction.
Key inclusion criteria (5 listed)
- Patients with no history of systemic disease e.g., diabetes.
- Both males and females will be included in the study.
- Control group: patients fit the case definition of gingival health2, and confirmed by Histopathological inflammatory cell infiltration analysis.
- Periodontitis group: patients fit the case definition of periodontal disease referred for periodontal flap surgery (modified Widman's flap).
- Patients radiographically confirmed with infrabony pocket eligible for periodontal flap surgery.
Key exclusion criteria (4 listed)
- Patients not willing to participate or consent.
- Patient taking medications that affect or modify immunity (e.g., corticosteroid), for the last 3 months.
- Patient taking NSAIDs for the last 3 months.
- Active smoker.
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 |
|---|---|---|
| periodontitis challengecontrol will be compared to diseased group suffering from periodontal disease. | Other | study group |
Primary outcome
determining the relative expression of lncRNAs (NEAT1 and MALAT1) in healthy and diseased periodontal tissue.
Time frame: one year
reverse transcription real time polymerase chain reaction
1 secondary outcome
determine the expression of EMT-related genes (E-cadherin, Vimentin, β-catenin, and Snail1), in healthy and diseased tissues, and their correlation with lncRNAs and clinical parameters.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontal Disease, AVDC Stage 3and 4 and Epithelial Mesenchymal Transition, run by Ali A Abdulkareem 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 5 inclusion and 4 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 12 Dec 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?
determining the relative expression of lncRNAs (NEAT1 and MALAT1) in healthy and diseased periodontal tissue. (time frame: one year). 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 Dec 2023.