An interventional study of Saliva, serum sampling and oral isotretinoin in Periodontal Diseases and Inflammation, sponsored by Medipol University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Medipol University · Not applicable, Interventional, and Prevention
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.
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).
830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.
This study's planned enrollment of 25 is below the median of 45 across 530 interventional studies indexed under Periodontal Diseases.
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Exclusion Criteria:
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
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
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.
Time frame: 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)
Time frame: 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.
Time frame: 6 months
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).
Time frame: 1 month
Plan to share: No
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