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

NCT07142070 | Not Yet Recruiting

• 1 other identifier: 1386
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases; Inflammation

Keywords

periodontal disease; miRNA

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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.

  6 months

Secondary Outcomes (1)

• Saliva, serum samples processing and analyses

  1 month

Study Arms (1)

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.

Other: Saliva, serum sampling; Drug: oral isotretinoin

Interventions

Saliva, serum sampling 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.

Experimental

oral isotretinoin DRUG

oral isotretinoin

Experimental

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University, School of Dentistry

Istanbul, Fatih, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Inflammation

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof Dr

Model Details: Saliva, serum collected for analyzing tnf-a, miRNA

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 26, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)