Periodontal DiseasesNCT07142070
Effect of Systemic Retinoic Acid Use on Micro Ribonucleic Acid (mRNA) Expression
A study testing Saliva, serum sampling and oral isotretinoin in people with Periodontal Diseases and Inflammation, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Ribonucleic acids (RNA) are molecules that transfer genetic information from the nucleus to the cytoplasm for protein translation. A subgroup of non-coding or non-messenger RNAs, known as microRNAs (miRNAs), regulates the expression of complementary mRNAs without coding for proteins. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Inflammation
- What is being tested?
- Saliva, serum sampling and oral isotretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- systemically healthy
- over 18 and under 45 years of age
- have at least 20 natural permanent teeth in occlusion excluding third molars,
- not be pregnant,
- have not used any antimicrobial and/or anti-inflammatory drugs in the past 3 months,
- have not received periodontal treatment in the past 6 months,
- have not undergone surgical periodontal treatment within the past year.
Who cannot join
- history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)
- nonsurgical periodontal treatment (previous 6 months)
- surgical periodontal treatment (previous 12 months)
- current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Medipol University, School of Dentistry
Istanbul, Fatih
About this study
Official title: Evaluation of the Effect of Systemic Retinoic Acid Use on Micro Ribonucleic Acid (mRNA) Expression in Saliva and Serum
Ribonucleic acids (RNA) are molecules that transfer genetic information from the nucleus to the cytoplasm for protein translation. A subgroup of non-coding or non-messenger RNAs, known as microRNAs (miRNAs), regulates the expression of complementary mRNAs without coding for proteins. In this study, the investigators aimed to evaluate the effect of systemically administered oral isotretinoin on gingival health in terms of microRNA (miRNA), a molecule of interest in periodontal research, before, during, and after treatment.
Read the detailed description
Healthy participants (n:25) enrolled for this study. Samples will be collected for each patient at the following time points: immediately before the initiation of retinoic acid treatment, during treatment at week 5 (T1), during treatment at month 5 (T2), and three months after the end of treatment (T3).
- Conditions
- Periodontal Diseases, Inflammation
- Being tested
- Saliva, serum sampling, oral isotretinoin
- Keywords
- periodontal disease, miRNA
- Medical subject headings
- Periodontal Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva, serum samplingOther
Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff from each participant (Periopaper, Oraflow Inc., Plainview, NY, USA). Saliva, serum were then stored at -80 °C until analysis.
oral isotretinoinDrug
oral isotretinoin
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Salivary, serum, miRNA, TNF-a observation Saliva, serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for TNF-a using commercial ELISA kits (Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions. Receives: Other: Saliva, serum sampling; Drug: oral isotretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket probing depth
Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
Measured: 6 months
Clinical attachment level
Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ.
To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth.
In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)
Measured: 6 months
Bleeding on probing
referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.
Measured: 6 months
Secondary outcomes (1)
Saliva, serum samples processing and analyses
Saliva, serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for TNF-a using commercial ELISA kits. RT-qPCR-based miRNA gene expression analyses will be performed using Two-Step qRT-PCR Kits (Thermo Fisher Scientific, MA, USA).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Saliva, serum collected for analyzing tnf-a, miRNA
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melis Yilmaz, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142070
- Sponsor's protocol ID
- 1386
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Systemic Retinoic Acid Use on Micro Ribonucleic Acid (mRNA) Expression in Saliva and Serum
- ClinicalTrials.gov ID
- NCT07142070
- Acronym / sponsor ID
- 1386
- Conditions
- Periodontal Diseases, Inflammation
- Keywords
- periodontal disease, miRNA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 26 Aug 2025 (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.
Ribonucleic acids (RNA) are molecules that transfer genetic information from the nucleus to the cytoplasm for protein translation. A subgroup of non-coding or non-messenger RNAs, known as microRNAs (miRNAs), regulates the expression of complementary mRNAs without coding for proteins. In this study, the investigators aimed to evaluate the effect of systemically administered oral isotretinoin on gingival health in terms of microRNA (miRNA), a molecule of interest in periodontal research, before, during, and after treatment.
Detailed description
Healthy participants (n:25) enrolled for this study. Samples will be collected for each patient at the following time points: immediately before the initiation of retinoic acid treatment, during treatment at week 5 (T1), during treatment at month 5 (T2), and three months after the end of treatment (T3).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Saliva, serum collected for analyzing tnf-a, miRNA
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Saliva, serum sampling, Drug: oral isotretinoinSalivary, serum, miRNA, TNF-a observation Saliva, serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for TNF-a using commercial ELISA kits (Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- systemically healthy
- over 18 and under 45 years of age
- have at least 20 natural permanent teeth in occlusion excluding third molars,
- not be pregnant,
- have not used any antimicrobial and/or anti-inflammatory drugs in the past 3 months,
Key exclusion criteria (5 listed)
- history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)
- nonsurgical periodontal treatment (previous 6 months)
- surgical periodontal treatment (previous 12 months)
- current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
- pregnancy
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 |
|---|---|---|
| Saliva, serum samplingSaliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff from each participant (Periopaper, Oraflow Inc., Plainview, NY, USA). Saliva, serum were then stored at -80 °C until analysis. | Other | Experimental |
| oral isotretinoinoral isotretinoin | Drug | Experimental |
Primary outcome
Pocket probing depth
Time frame: 6 months
Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
Clinical attachment level
Time frame: 6 months
Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ. To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth. In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)
Bleeding on probing
Time frame: 6 months
referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.
1 secondary outcome
Saliva, serum samples processing and analyses
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Saliva, serum sampling and oral isotretinoin in people with Periodontal Diseases and Inflammation, run by Medipol University 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pocket probing depth (time frame: 6 months). 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 26 Aug 2025.