- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07666126
Evaluation of the Effect of Hyperuricemia on Alveolar Bone Loss
Evaluation of the Effect of Hyperuricemia on Alveolar Bone Loss and Oxidative Stress
Periodontitis is a multifactorial disease characterized by chronic inflammation of the gum tissue and alveolar bone destruction, and is known to be associated with various systemic diseases. Hyperuricemia, on the other hand, is a metabolic condition characterized by increased serum uric acid levels and can affect inflammation, oxidative stress, and bone metabolism. In recent years, the relationship between hyperuricemia and periodontal diseases has been increasingly investigated, but the biological mechanisms of this relationship have not yet been fully elucidated. Therefore, this study aimed to determine whether there is a relationship between hyperuricemia and periodontitis and to reveal the possible pathophysiological mechanisms of this relationship, which are shaped by inflammation, oxidative stress, and bone metabolism.
A total of 80 individuals aged 18-65 years will be included in this clinical observational study. The periodontal status of the participants will be assessed using clinical periodontal parameters such as probing pocket depth, clinical attachment loss, plaque index, gingival index, and bleeding on probing. Participants will be divided into four groups according to their periodontal status and the presence of hyperuricemia: individuals with periodontitis and hyperuricemia, individuals with periodontally healthy and hyperuricemia, individuals with periodontitis but without hyperuricemia, and individuals with periodontally healthy and without hyperuricemia. Gingival crevicular fluid and serum samples will be taken from the participants. In these samples, receptor-mediated nuclear factor kappa B ligand, osteoprotegerin, total antioxidant status, total oxidant status, oxidative stress index, interleukin-1 beta, interleukin-10, interleukin-18, and nucleotide-binding oligomerization domain-like receptor protein 3 levels will be analyzed. This study is considered unique because it examines the relationship between hyperuricemia and periodontitis by evaluating inflammation, oxidative stress, and bone metabolism parameters together.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hatice Yemenoglu
- Phone Number: +905052977517
- Email: htcymnglu@hotmail.com
Study Locations
-
-
-
Rize, Turkey (Türkiye), 53020
- Recruiting
- Recep Tayyip Erdogan University
-
Contact:
- Hatice Yemenoglu
- Phone Number: +904642220000
- Email: htcymnglu@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being between 18 and 65 years of age
- Being systemically healthy or diagnosed with hyperuricemia
- Having at least 20 natural teeth
- Being periodontally healthy or diagnosed with periodontitis
Exclusion Criteria:
- Diabetes, cardiovascular disease, osteoporosis, chronic kidney disease, metabolic syndrome, and obesity are systemic diseases that may affect purine metabolism.
- Smoking
- Pregnancy or lactation
- Having received periodontal treatment within the last 3-6 months
- Use of antibiotics, anti-inflammatory drugs, or uric acid-lowering drugs
- Presence of systemic diseases that may affect purine metabolism
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1: Individuals with periodontitis and hyperuricemia
|
Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
|
|
Group 2: Periodontally healthy individuals with hyperuricemia
|
Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
|
|
Group 3: Individuals with periodontitis but without hyperuricemia
|
Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
|
|
Group 4: Periodontally healthy individuals without hyperuricemia
|
Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Periodontal pocket depth
Time Frame: at baseline
|
The distance between the gingival margin and the base of the pocket will be measured in millimeters.
|
at baseline
|
|
clinical attachment loss
Time Frame: at baseline
|
The distance between the enamel-cementum junction and the base of the pocket will be measured in millimeters.
|
at baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of interleukin-1 beta
Time Frame: at baseline
|
Interleukin-1 beta levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
|
at baseline
|
|
Level of interleukin-10
Time Frame: at baseline
|
Interleukin-10 levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
|
at baseline
|
|
Level of interleukin-18
Time Frame: at baseline
|
Interleukin-18 levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
|
at baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/302
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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