Retinoic Acid Therapy and Regulation of Salivary and Serum IL-1β, IL-8 and MCP-1 Levels

NCT06879795 | Completed

• 1 other identifier: 1108
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acne Vulgaris; Gingivitis and Periodontal Diseases; Saliva Collection; Inflammation Biomarkers; Vitamin A

Keywords

chemokines; inflammation; periodontal health; retinoic acid; saliva

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36440958 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

saliva and serum samples

MeSH Terms

Conditions

Acne Vulgaris; Gingivitis; Periodontal Diseases; Inflammation

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Dental Surgery, PhD Student

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 17, 2025
• Study Start: September 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)