Acne VulgarisNCT06879795
Retinoic Acid Therapy and Regulation of Salivary and Serum IL-1β, IL-8 and MCP-1 Levels
An observational study of Acne Vulgaris and Gingivitis and Periodontal Diseases, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This prospective cohort study analysed the effects of systemic retinoic acid use on periodontal status, salivary flow rate (SFR), and salivary and serum levels of interleukin (IL)-1β, IL-8 and monocyte chemoattractant protein (MCP)-1. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris, Gingivitis and Periodontal Diseases, Saliva Collection
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Jul 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patient recruitment, data collection, and sample acquisition were conducted at Istanbul Medipol University, Faculty of Dentistry, and Istanbul Medipol University Mega Hospital, Dermatology Clinic, Turkey, between September 2023 and July 2024.
Who may be able to join
- Directed to use isotretinoin 0,5 to 1 mg/kg/day for 6 months for the treatment of moderate and severe acne vulgaris or nodular acne according to the global acne rating by dermatologist
- Being at the age range of 18-30 years old
- Willing to participate to the study
- Periodontally Healthy
Who cannot join
- Systemic diseases other than acne vulgaris or nodular acne
- Use of antibiotics, anti-inflammatory drugs, nonsteroidal anti-inflammatory drugs, steroids, immunosuppressants, beta-blockers, calcium channel blockers, anticoagulants, or hormonal contraceptives within 6 months prior to the initiation of the study
- Pregnancy or being lactating
- Excessive use of alcohol
- Smoking
- Received nonsurgical periodontal therapy during preceding 6 months or surgical periodontal therapy during preceding 12 months
- Have fewer than 20 natural teeth excluding third molars
- Have orthodontic appliances.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Systemic Retinoic Acid Use on Periodontium-Related T Cell Differentiation
This prospective cohort study analysed the effects of systemic retinoic acid use on periodontal status, salivary flow rate (SFR), and salivary and serum levels of interleukin (IL)-1β, IL-8 and monocyte chemoattractant protein (MCP)-1.
Read the detailed description
Vitamin A (isotretinoin, 13-cis-retinoic acid) and its metabolites are essential for various biological processes, including vision, development, and immune regulation. The periodontium, which consists of tissues supporting the teeth, can transition from health to disease due to multiple factors. The impact of retinoic acid (RA) on periodontal tissues has primarily been investigated in vitro; however, evidence suggests that it may reduce alveolar bone destruction and modulate cytokine expression, indicating potential anti-inflammatory properties. Nevertheless, there is a lack of studies examining the relationship between RA and periodontal health.
This study aims to evaluate the potential association between systemic RA use and the periodontal tissue response in terms of inflammatory markers (cytokines: IL-1β, IL-8; chemokines: MCP-1) and to assess dental/periodontal status at different time intervals. The study hypothesizes that RA use will enhance the periodontal tissue response independently of the existing bacterial biofilm and its quantity in the oral cavity, thereby negatively affecting the maintenance of periodontal health through alterations in the periodontium's defense mechanisms.
Saliva and serum samples from 24 participants were collected to assess inflammatory responses. The samples were obtained and stored at Istanbul Medipol University Mega Hospital, Turkey, and subsequently transferred to the University of Turku, Finland, for laboratory analyses. Serum and saliva samples were analyzed for inflammatory markers (IL-1β, IL-8, MCP-1) using multiplex immunoassay kits (Millipore; MILLIPLEX® Human Cytokine/Chemokine/Growth Factor Panel A-Immunology Multiplex Assay, #HCYTA-60K, Merck Millipore, Massachusetts, MA). Additionally, sociodemographic, dental, and periodontal data of each participant were analyzed.
This study will contribute to understanding the potential relationship between RA and periodontal status, as well as the effects of RA on the inflammatory response of periodontal tissues.
- Conditions
- Acne Vulgaris, Gingivitis and Periodontal Diseases, Saliva Collection, Inflammation Biomarkers, Vitamin A
- Keywords
- chemokines, inflammation, periodontal health, retinoic acid, saliva
- Medical subject headings
- Acne Vulgaris, Gingivitis, Periodontal Diseases, Inflammation
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 |
|---|---|---|
| retinoic acid users | A total of 24 periodontally healthy participants who were prescribed isotretinoin (Retinoic acid) (0.5-1 mg/kg/day) for six months to treat moderate to severe acne vulgaris or nodular acne, based on the Global Acne Grading System, were included in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding on probing
To assess the inflammatory status of the pocket base and pocket epithelium, bleeding was recorded 30 seconds after probing depth measurement. The presence of bleeding was scored as positive (+), while the absence of bleeding was recorded as negative (-).
The percentage value of the Bleeding on Probing for each patient was calculated using the following formula:
(Number of bleeding surfaces / Total number of tooth surfaces) × 100
Measured: at 4 time point: before retinoic acid treatment, during(6th week and 5th month) retinoic acid treatment and 2nd month after completion of retinoic acid therapy
IL-1beta, IL-8 and MCP-1 levels
Interleukin(IL)-1beta, IL-8 and monocyte chemoattractant protein (MCP)-1 are inflammatory cytokines which show inflamatory changes.
Measured: at 4 time point: before retinoic acid treatment, during(6th week and 5th month) retinoic acid treatment and 2nd month after completion of retinoic acid therapy
salivary flow rate
Salivary flow rate was calculated by the collected saliva volume SFR=Volume of saliva (mL) collected in 10 minutes/10 minutes.
Measured: at 4 time point: before retinoic acid treatment, during(6th week and 5th month) retinoic acid treatment and 2nd month after completion of retinoic acid therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Sep 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bestegül günay, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879795
- Sponsor's protocol ID
- 1108
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atalay N, Balci N, Toygar HU, Yardimci G, Gursoy UK. Serum, saliva, and gingival tissue human beta-defensin levels in relation to retinoic acid use. J Periodontol. 2023 May;94(5):597-605. doi: 10.1002/JPER.22-0466. Epub 2022 Dec 19.
PubMed 36440958Gunay B, Balci N, Toygar H, Balevi A, Gursoy M, Suominen A, Gursoy UK. The effects of retinoic acid therapy on salivary and serum IL-1beta, IL-8 and MCP-1 levels in periodontally healthy individuals: a prospective cohort study. Clin Oral Investig. 2025 Oct 28;29(11):538. doi: 10.1007/s00784-025-06611-y.
PubMed 41148381
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systemic Retinoic Acid Use on Periodontium-Related T Cell Differentiation
- ClinicalTrials.gov ID
- NCT06879795
- Acronym / sponsor ID
- 1108
- Conditions
- Acne Vulgaris, Gingivitis and Periodontal Diseases, Saliva Collection, Inflammation Biomarkers, Vitamin A
- Keywords
- chemokines, inflammation, periodontal health, retinoic acid, saliva
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 17 Mar 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.
This prospective cohort study analysed the effects of systemic retinoic acid use on periodontal status, salivary flow rate (SFR), and salivary and serum levels of interleukin (IL)-1β, IL-8 and monocyte chemoattractant protein (MCP)-1.
Detailed description
Vitamin A (isotretinoin, 13-cis-retinoic acid) and its metabolites are essential for various biological processes, including vision, development, and immune regulation. The periodontium, which consists of tissues supporting the teeth, can transition from health to disease due to multiple factors. The impact of retinoic acid (RA) on periodontal tissues has primarily been investigated in vitro; however, evidence suggests that it may reduce alveolar bone destruction and modulate cytokine expression, indicating potential anti-inflammatory properties. Nevertheless, there is a lack of studies examining the relationship between RA and periodontal health.
This study aims to evaluate the potential association between systemic RA use and the periodontal tissue response in terms of inflammatory markers (cytokines: IL-1β, IL-8; chemokines: MCP-1) and to assess dental/periodontal status at different time intervals. The study hypothesizes that RA use will enhance the periodontal tissue response independently of the existing bacterial biofilm and its quantity in the oral cavity, thereby negatively affecting the maintenance of periodontal health through alterations in the periodontium's defense mechanisms.
Saliva and serum samples from 24 participants were collected to assess inflammatory responses. The samples were obtained and stored at Istanbul Medipol University Mega Hospital, Turkey, and subsequently transferred to the University of Turku, Finland, for laboratory analyses. Serum and saliva samples were analyzed for inflammatory markers (IL-1β, IL-8, MCP-1) using multiplex immunoassay kits (Millipore; MILLIPLEX® Human Cytokine/Chemokine/Growth Factor Panel A-Immunology Multiplex Assay, #HCYTA-60K, Merck Millipore, Massachusetts, MA). Additionally, sociodemographic, dental, and periodontal data of each participant were analyzed.
This study will contribute to understanding the potential relationship between RA and periodontal status, as well as the effects of RA on the inflammatory response of periodontal tissues.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| retinoic acid users | – | –A total of 24 periodontally healthy participants who were prescribed isotretinoin (Retinoic acid) (0.5-1 mg/kg/day) for six months to treat moderate to severe acne vulgaris or nodular acne, based on the Global Acne Grading System, were included in the study. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patient recruitment, data collection, and sample acquisition were conducted at Istanbul Medipol University, Faculty of Dentistry, and Istanbul Medipol University Mega Hospital, Dermatology Clinic, Turkey, between September 2023 and July 2024.
Key inclusion criteria (4 listed)
- Directed to use isotretinoin 0,5 to 1 mg/kg/day for 6 months for the treatment of moderate and severe acne vulgaris or nodular acne according to the global acne rating by dermatologist
- Being at the age range of 18-30 years old
- Willing to participate to the study
- Periodontally Healthy
Key exclusion criteria (8 listed)
- Systemic diseases other than acne vulgaris or nodular acne
- Use of antibiotics, anti-inflammatory drugs, nonsteroidal anti-inflammatory drugs, steroids, immunosuppressants, beta-blockers, calcium channel blockers, anticoagulants, or hormonal contraceptives within 6 months prior to the initiation of the study
- Pregnancy or being lactating
- Excessive use of alcohol
- Smoking
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
bleeding on probing
Time frame: at 4 time point: before retinoic acid treatment, during(6th week and 5th month) retinoic acid treatment and 2nd month after completion of retinoic acid therapy
To assess the inflammatory status of the pocket base and pocket epithelium, bleeding was recorded 30 seconds after probing depth measurement. The presence of bleeding was scored as positive (+), while the absence of bleeding was recorded as negative (-). The percentage value of the Bleeding on Probing for each patient was calculated using the following formula: (Number of bleeding surfaces / Total number of tooth surfaces) × 100
IL-1beta, IL-8 and MCP-1 levels
Time frame: at 4 time point: before retinoic acid treatment, during(6th week and 5th month) retinoic acid treatment and 2nd month after completion of retinoic acid therapy
Interleukin(IL)-1beta, IL-8 and monocyte chemoattractant protein (MCP)-1 are inflammatory cytokines which show inflamatory changes.
salivary flow rate
Time frame: at 4 time point: before retinoic acid treatment, during(6th week and 5th month) retinoic acid treatment and 2nd month after completion of retinoic acid therapy
Salivary flow rate was calculated by the collected saliva volume SFR=Volume of saliva (mL) collected in 10 minutes/10 minutes.
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 17 Mar 2025.
- Background: PubMed 36440958Atalay N, Balci N, Toygar HU, Yardimci G, Gursoy UK. Serum, saliva, and gingival tissue human beta-defensin levels in relation to retinoic acid use. J Periodontol. 2023 May;94(5):597-605. doi: 10.1002/JPER.22-0466. Epub 2022 Dec 19.
- Derived from this study: PubMed 41148381Gunay B, Balci N, Toygar H, Balevi A, Gursoy M, Suominen A, Gursoy UK. The effects of retinoic acid therapy on salivary and serum IL-1beta, IL-8 and MCP-1 levels in periodontally healthy individuals: a prospective cohort study. Clin Oral Investig. 2025 Oct 28;29(11):538. doi: 10.1007/s00784-025-06611-y.
- 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. 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 Acne Vulgaris and Gingivitis and Periodontal Diseases, 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 4 inclusion and 8 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 17 Mar 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?
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?
bleeding on probing (time frame: at 4 time point: before retinoic acid treatment, during(6th week and 5th month) retinoic acid treatment and 2nd month after completion of retinoic acid therapy). 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?
On the ClinicalTrials.gov record for NCT06879795, which also lists 2 linked publications.
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 17 Mar 2025.