Periodontitis, AdultNCT06064799
GCF miRNA-223 , -214 Levels in Smokers and Nonsmokers Periodontitis Patients
An observational study of Periodontitis, Adult, run by Fayoum University at 1 site in Egypt.
Trial summary
Objective: Periodontitis is a multifactorial disease that affects a wide range of populations. However, its pathogenesis remains unclear. miRNAs are now considered potential diagnostic markers for many inflammatory diseases. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- miRNA-223 & -214 detection
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: individuals were recruited from the outpatient clinic of the department of periodontology
Who may be able to join
- both genders
- age from 20 to 60 years
- no more than 4 teeth lost due to periodontitis
- systemically free participants
Who cannot join
- Pregnant or lactating female
- participants with a history of an inflammatory or immunological disease
- history of any current medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expression of microRNA-223 and microRNA-214 in Gingival Crevicular Fluid of Smoker and Nonsmoker Periodontitis Patients, an Observational Diagnostic Accuracy Study
Objective: Periodontitis is a multifactorial disease that affects a wide range of populations. However, its pathogenesis remains unclear. miRNAs are now considered potential diagnostic markers for many inflammatory diseases. Thus, the aim of this study was to assess the expression of microRNA-223(miRNA-223) and microRNA-214 (miRNA-214) in gingival crevicular fluid (GCF) of smoker and nonsmoker with periodontitis.
Materials and Methods: We conducted a prospective study among 42 participants: 14 healthy controls, 14 nonsmoker periodontitis participants, and 14 smoker with periodontitis. Eligibility criteria for inclusion were consecutive adults, aged 20-60 years, with stage III periodontitis grade B/C and no systemic diseases. All consenting participants had gingival crevicular fluid samples collected after diagnosis to assess miRNA-214 and -223 by quantitative real-time polymerase chain reaction assay.
- Conditions
- Periodontitis, Adult
- Being tested
- miRNA-223 & -214 detection
- Keywords
- Periodontitis, microRNA, smoking, GCF, biofluids
- Medical subject headings
- Chronic Periodontitis, Periodontitis, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNA-223 & -214 detectionDiagnostic test
miRNA-223 \& -214 detection in GCF samples by PCR kits
| Study group | Role | What they receive |
|---|---|---|
| Group I | 14 healthy volunteers Receives: Diagnostic Test: miRNA-223 & -214 detection | |
| Group II | 14 periodontitis participants with stage III grade B Periodontitis Receives: Diagnostic Test: miRNA-223 & -214 detection | |
| Group III | 14 periodontitis participants with stage III grade C Periodontitis Receives: Diagnostic Test: miRNA-223 & -214 detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of miRNA-223 & -214 levels in GCF samples in all groups
PCR kits are used for assessment of miRNA-223 \& -214 levels in GCF samples in all groups
Measured: level of miR-223 & -214 are measured at baseline after the completion of all GCF sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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 Periodontitis, AdultStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe 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
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayroz Tarrad, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064799
- Sponsor's protocol ID
- REC-FDBSU/05012023-04/AM
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
AbdelKawy M, Tarrad NAF, Shaker OG, Hassan S. Expression of microRNA-223 and microRNA-214 in gingival crevicular fluid of smoker and nonsmoker periodontitis patients, an observational diagnostic accuracy study. Clin Oral Investig. 2024 Aug 10;28(9):480. doi: 10.1007/s00784-024-05844-7.
PubMed 39126506
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of microRNA-223 and microRNA-214 in Gingival Crevicular Fluid of Smoker and Nonsmoker Periodontitis Patients, an Observational Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT06064799
- Acronym / sponsor ID
- REC-FDBSU/05012023-04/AM
- Conditions
- Periodontitis, Adult
- Keywords
- Periodontitis, microRNA, smoking, GCF, biofluids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 3 Oct 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.
Objective: Periodontitis is a multifactorial disease that affects a wide range of populations. However, its pathogenesis remains unclear. miRNAs are now considered potential diagnostic markers for many inflammatory diseases. Thus, the aim of this study was to assess the expression of microRNA-223(miRNA-223) and microRNA-214 (miRNA-214) in gingival crevicular fluid (GCF) of smoker and nonsmoker with periodontitis.
Materials and Methods: We conducted a prospective study among 42 participants: 14 healthy controls, 14 nonsmoker periodontitis participants, and 14 smoker with periodontitis. Eligibility criteria for inclusion were consecutive adults, aged 20-60 years, with stage III periodontitis grade B/C and no systemic diseases. All consenting participants had gingival crevicular fluid samples collected after diagnosis to assess miRNA-214 and -223 by quantitative real-time polymerase chain reaction assay.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: miRNA-223 & -214 detection14 healthy volunteers |
| Group II | – | Diagnostic Test: miRNA-223 & -214 detection14 periodontitis participants with stage III grade B Periodontitis |
| Group III | – | Diagnostic Test: miRNA-223 & -214 detection14 periodontitis participants with stage III grade C Periodontitis |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- individuals were recruited from the outpatient clinic of the department of periodontology
Key inclusion criteria (4 listed)
- both genders
- age from 20 to 60 years
- no more than 4 teeth lost due to periodontitis
- systemically free participants
Key exclusion criteria (3 listed)
- Pregnant or lactating female
- participants with a history of an inflammatory or immunological disease
- history of any current medication
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 |
|---|---|---|
| miRNA-223 & -214 detectionmiRNA-223 \& -214 detection in GCF samples by PCR kits | Diagnostic test | Group I, Group II, Group III |
Primary outcome
assessment of miRNA-223 & -214 levels in GCF samples in all groups
Time frame: level of miR-223 & -214 are measured at baseline after the completion of all GCF sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation
PCR kits are used for assessment of miRNA-223 \& -214 levels in GCF samples in all groups
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 2023.
- Derived from this study: PubMed 39126506AbdelKawy M, Tarrad NAF, Shaker OG, Hassan S. Expression of microRNA-223 and microRNA-214 in gingival crevicular fluid of smoker and nonsmoker periodontitis patients, an observational diagnostic accuracy study. Clin Oral Investig. 2024 Aug 10;28(9):480. doi: 10.1007/s00784-024-05844-7.
Related trials for Periodontitis, Adult
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Not yet recruitingObservational study
Evaluation of Changes in Oral Health-related Quality of Life During the Treatment of Periodontitis.
Periodontitis, Adult, Periodontitis
Recruiting
HbA1c Screening in Dental Care and Primary Care Referral in Patients With Advanced Periodontitis
Periodontitis, Adult, Prediabetes / Type 2 Diabetes
RecruitingObservational study
Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement
Edentulous Mouth, Periodontal Diseases
Not yet recruiting
Profiling Gingival Crevicular Fluid β-Catenin Level With 8-OHdG and Total Antioxidants Capacity During Healing of Periodontal Pockets: A 3-month Clinical Trial
Periodontitis, Adult, Periodontal Diseases
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 Periodontitis, Adult, run by Fayoum University at 1 site in Egypt.
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 4 inclusion and 3 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 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 Egypt. 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?
assessment of miRNA-223 & -214 levels in GCF samples in all groups (time frame: level of miR-223 & -214 are measured at baseline after the completion of all GCF sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation). 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 NCT06064799, 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 3 Oct 2023.