Effect of Systemic Retinoic Acid Use on Micro Ribonucleic Acid (mRNA) Expression

NCT ID: NCT07142070

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-02-01

Brief 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. 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).

Conditions

Periodontal Diseases; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Saliva, serum sampling

Intervention Type: OTHER

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 isotretinoin

Intervention Type: DRUG

oral isotretinoin

Interventions

Saliva, serum sampling

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.

Intervention Type: OTHER

oral isotretinoin

oral isotretinoin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Melis Yilmaz

Assistant Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medipol University, School of Dentistry

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1386

Identifier Type: -

Identifier Source: org_study_id