- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06933797
Evaluation of the Potential Effects of LRP5 and Tph1 in the Pathogenesis of Periodontal Disease Individuals With Stage III Grade B Periodontitis
Evaluation of the Changes in LRP5 and TPH1 Levels Due to Periodontal Inflammation
Objectives: The aim of this study was to determine the changes in LRP5 and TPH1 levels in serum and saliva samples due to periodontal inflammation and to evaluate the relationship between these values and clinical periodontal parameters.
Methods: Saliva and serum samples were collected from 20 systemically healthy patients with Stage III periodontitis and 20 periodontally healthy control individuals. Salivary and serum LRP5 and TPH1 levels were analyzed using enzyme-linked immunosorbent assay (ELISA). Clinical periodontal parameters, including plaque index (PI), probing pocket depth (PPD), bleeding on probing (BOP), and clinical attachment level (CAL), were recorded.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Yenimahalle
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Ankara, Yenimahalle, Turkey, 06500
- Ankara University, Faculty of Dentistry,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- >18 years old,
- At least 16 permanent teeth except 3rd molars,
- Individuals who do not use orthodontic appliances,
- Individuals who are not pregnant or lactating,
- Individuals without any systemic disease that may affect periodontal health,
- Systemically healthy individuals,
- Individuals who have not used anti-inflammatory and/or anti-microbial drugs in the last 6 months,
- Individuals who have not received periodontal treatment in the last 1 year
Exclusion Criteria:
- Pregnant/lactating individuals,
- Individuals who have used anti-inflammatory and/or anti-microbial drugs in the last 6 months,
- Individuals who have undergone periodontal treatment in the last 1 year,
- Individuals with psychiatric illness,
- Individuals with any oral infection,
- Individuals with <16 teeth, excluding molars,
- Individuals with alcohol dependence,
- Individuals with active infectious disease (acute hepatitis, AIDS, tuberculosis), cancer or any systemic condition that may affect periodontal tissues,
- Individuals receiving treatment with drugs known to affect periodontal tissues (phenytoin, cyclosporine A, calcium channel blockers)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Stage III periodontitis
Individuals exhibiting pocket depths of >3 mm in at least two non-adjacent teeth, radiographic evidence of alveolar bone loss extending to the middle or apical third of the root, and tooth loss of ≤4 due to periodontitis were classified as having Stage III periodontitis.
The additional criterion for Grade B classification was defined as a % bone loss/age ratio of 0.25-1.
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Periodontally healthy
Individuals with no signs of alveolar bone loss and an overall oral bleeding score <10% were categorized as periodontally healthy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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LRP5
Time Frame: 1 month
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Low-density lipoprotein (LDL) receptor-related protein 5 (LRP5) is a WNT coreceptor in the LRP superfamily involved in a wide range of biological processes including endocytosis, cellular communication, lipid homeostasis and embryonic development.
The levels of LRP5 in both serum and saliva samples were determined using commercially available ELISA kits.
All assays were conducted according to the manufacturers' instructions.
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1 month
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TPH1
Time Frame: 1 month
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The inhibitory, irreversible enzyme of serotonin synthesis from intestinal cells is tryptophan hydroxylase 1 (TPH1).
The levels of TPH1 in both serum and saliva samples were determined using commercially available ELISA kits.
All assays were conducted according to the manufacturers' instructions.
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1 month
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Yadav VK, Ryu JH, Suda N, Tanaka KF, Gingrich JA, Schutz G, Glorieux FH, Chiang CY, Zajac JD, Insogna KL, Mann JJ, Hen R, Ducy P, Karsenty G. Lrp5 controls bone formation by inhibiting serotonin synthesis in the duodenum. Cell. 2008 Nov 28;135(5):825-37. doi: 10.1016/j.cell.2008.09.059.
- Jiang H, Xi Y, Jiang Q, Dai W, Qin X, Zhang J, Jiang Z, Yang G, Chen Q. LRP5 Down-Regulation Exacerbates Inflammation and Alveolar Bone Loss in Periodontitis by Inhibiting PI3K/c-FOS Signalling. J Clin Periodontol. 2025 Jan 21. doi: 10.1111/jcpe.14112. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36290600/03/2024
- 1919B012319473 (Other Grant/Funding Number: The Scientific and Technological Research Council of Türkiye (TÜBİTAK))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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