- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07598942
Gingival TrxR1 Expression in Periodontal Health and Periodontitis
14 maj 2026 uppdaterad av: Fuat Cetinkaya, Ataturk University
Thioredoxin Reductase 1 Levels in Gingival Tissue as an Oxidative Stress Biomarker in Periodontitis
This study aims to investigate the role of the thioredoxin system in the development and progression of periodontitis.
Researchers will examine the levels of specific antioxidant markers, such as thioredoxin reductase 1 (TrxR1), glutathione (GSH), and malondialdehyde (MDA), in gingival tissue samples collected from healthy individuals and patients with different stages of periodontal disease.
The goal is to determine if TrxR1 levels can serve as a potential biomarker for diagnosing the severity and activity of periodontitis.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
60
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Erzurum, Turkiet (Türkiye), 25240
- Ataturk University Faculty of Dentistry
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients visiting the Department of Periodontology at Atatürk University Faculty of Dentistry who meet the clinical criteria for health or periodontitis.
Beskrivning
Inclusion Criteria:
- Being between the ages of 18 and 70.
- Having no known systemic disease.
- Non-smokers.
- No history of medication or supplement use in the last 3 months.
- For the Periodontitis groups: Interdental clinical attachment loss (CAL), probing pocket depth (PPD), and radiographic bone loss according to 2017 World Workshop criteria.
Exclusion Criteria:
- Smoking.
- Pregnancy or breastfeeding.
- Presence of a systemic disease (e.g., diabetes mellitus, hypertension, rheumatoid arthritis, cancer, thyroid disorders, kidney or lung diseases).
- History of any periodontal surgical procedure within the last 6 months.
- Use of medication or supplements within the last 3 months.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Healthy Control Group
Systemically and periodontally healthy individuals with no history of bone loss, probing depths ≤ 3 mm, and bleeding on probing < 10%.
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Gingival tissue samples are collected from all participants.
These samples are analyzed for Glutathione (GSH) and Malondialdehyde (MDA) levels using spectroscopic methods.
Additionally, the expression of thioredoxin reductase 1 (TrxR1), thioredoxin (TXN), and thioredoxin-interacting protein (TXNIP) is determined through quantitative real-time PCR, western blot, and enzyme activity assays.
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Stage 1-2 Periodontitis Group
Patients diagnosed with Stage 1 or Stage 2 periodontitis according to the 2017 World Workshop classification, characterized by interdental clinical attachment loss and radiographic bone loss.
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Gingival tissue samples are collected from all participants.
These samples are analyzed for Glutathione (GSH) and Malondialdehyde (MDA) levels using spectroscopic methods.
Additionally, the expression of thioredoxin reductase 1 (TrxR1), thioredoxin (TXN), and thioredoxin-interacting protein (TXNIP) is determined through quantitative real-time PCR, western blot, and enzyme activity assays.
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Stage 3-4 Periodontitis Group
Patients diagnosed with Stage 3 or Stage 4 periodontitis, characterized by severe clinical attachment loss, deep probing depths, and significant radiographic bone loss potentially leading to tooth loss.
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Gingival tissue samples are collected from all participants.
These samples are analyzed for Glutathione (GSH) and Malondialdehyde (MDA) levels using spectroscopic methods.
Additionally, the expression of thioredoxin reductase 1 (TrxR1), thioredoxin (TXN), and thioredoxin-interacting protein (TXNIP) is determined through quantitative real-time PCR, western blot, and enzyme activity assays.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Thioredoxin Reductase 1 (TrxR1) mRNA Expression Levels
Tidsram: Baseline (at the time of tissue collection)
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The expression levels of TrxR1 in gingival tissue are determined by quantitative real-time PCR (qPCR).
This measure evaluates the potential of TrxR1 as a biomarker for periodontitis severity.
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Baseline (at the time of tissue collection)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Thioredoxin (TXN) mRNA Expression Levels
Tidsram: Baseline (at the time of tissue collection)
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Evaluation of TXN gene expression levels in gingival tissue samples using quantitative real-time PCR (qPCR) normalized to β-actin.
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Baseline (at the time of tissue collection)
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Thioredoxin-Interacting Protein (TXNIP) mRNA Expression Levels
Tidsram: Baseline (at the time of tissue collection)
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Evaluation of TXNIP gene expression levels in gingival tissue samples using quantitative real-time PCR (qPCR) normalized to β-actin. Time Frame: Baseline (at the time of tissue collection) |
Baseline (at the time of tissue collection)
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Malondialdehyde (MDA) Levels.
Tidsram: Baseline (at the time of tissue collection).
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MDA levels in gingival tissue homogenates measured using the thiobarbituric acid reactive substances (TBARS) assay to evaluate lipid peroxidation.
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Baseline (at the time of tissue collection).
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Glutathione (GSH) Levels.
Tidsram: Baseline (at the time of tissue collection).
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GSH levels in gingival tissue homogenates measured using spectroscopic methods to evaluate antioxidant status.
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Baseline (at the time of tissue collection).
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 augusti 2023
Primärt slutförande (Faktisk)
10 augusti 2025
Avslutad studie (Faktisk)
15 oktober 2025
Studieregistreringsdatum
Först inskickad
14 maj 2026
Först inskickad som uppfyllde QC-kriterierna
14 maj 2026
Första postat (Faktisk)
20 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B.30.2.ATA.0.01.00/163
- TDK-2023-13289 (Annan identifierare: Atatürk University Scientific Research Projects)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Individual participant data that underlie the results reported in this article, after de-identification, will be made available upon request.
Tidsram för IPD-delning
Data will be available beginning 6 months and ending 36 months following article publication.
Kriterier för IPD Sharing Access
Proposals should be directed to turgdemir@hotmail.com.
To gain access, data requestors will need to sign a data access agreement.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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