Evaluation of Bone Metabolism Biomarkers in Periodontal Diseases
January 18, 2023 updated by: Ummuhan Tekin Atay, Necmettin Erbakan University
Evaluation Of Biomarkers Associated With Bone Metabolism İn Patients With Different Periodontal Status
This study evaluates the levels of biomarkers associated with bone metabolism in patients with different periodontal conditions.
Study Overview
Detailed Description
Background: In this study, the levels of bone metabolism markers found in the saliva of individuals with different periodontal conditions were compared and the relationship of these markers with periodontal status was examined.
Method: A total of 60 individuals, 20 with periodontitis (P), 20 with gingivitis (G), and 20 with periodontal healthy (S), were included in the study. Periodontal clinical parameters (plaque index, gingival index, bleeding on probing, clinical attachment level and probing pocket depth) and saliva samples were obtained from the individuals. Bone metabolism biomarker (necrotizing factor (TNF)-α, osteoprotegerin (OPG), nuclear factor kappa-β receptor activator ligand (RANKL) and sclerostin) levels in saliva samples were evaluated by enzyme-linked immunosorbent assay (ELISA).
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Konya, Turkey
- Necmettin Erbakan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-65 years old.
- not having any systemic disease that may affect periodontal status
- not smoking and alcohol use
- volunteer to participate in the study
Exclusion Criteria:
- periapical pathologies;
- resulting from orthodontics and occlusion extreme forces, including mechanical forces;
- chronic high-dose steroid therapy;
- radiation or immunosuppressive therapy;
- pregnancy;
- breastfeeding;
- allergy or sensitivity to any medication.
- Periodontal therapy or drug therapy for at least 6 months of study participants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: periodontitis
|
ELISA(enzyme-linked immunosorbent assay)
|
|
Experimental: gingivitis
|
ELISA(enzyme-linked immunosorbent assay)
|
|
Experimental: periodontal healthy
|
ELISA(enzyme-linked immunosorbent assay)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of bone metabolism biomarkers in different periodontal conditions
Time Frame: baseline
|
The levels of bone metabolism markers in the saliva of individuals with different periodontal status were compared and the relationship of these markers with periodontal status was examined.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Probing pocket depth
Time Frame: baseline
|
Probing pocket depth(PPD) was measured for determining the severity of the disease and clinical outcome.
High probing depth shows more severe periodontal disease.
|
baseline
|
|
Gingival index
Time Frame: baseline
|
The differences in gingival index scores between periodontally healthy and periodontitis.The gingival index was recorded for determining and classifying gingival status.
The gingival index (Gİ) scores each site on a 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling and spontaneous bleeding.
|
baseline
|
|
Plaque index
Time Frame: baseline
|
The differences in plaque index scores between periodontally healthy and periodontitis.
Plaque index (PI) was recorded for determining and classifying oral hygiene status.
The plaque index (PI) scores each site on a with 0 being no plaque in gingival area and 3 abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 5, 2020
Primary Completion (Actual)
May 5, 2021
Study Completion (Actual)
November 5, 2021
Study Registration Dates
First Submitted
January 9, 2023
First Submitted That Met QC Criteria
January 18, 2023
First Posted (Actual)
January 27, 2023
Study Record Updates
Last Update Posted (Actual)
January 27, 2023
Last Update Submitted That Met QC Criteria
January 18, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ummuhan.tekinatay
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.