Evaluation of Bone Metabolism Biomarkers in Periodontal Diseases

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

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Diagnostic test: ELISA

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

Study Locations

• Turkey
  • Konya, Turkey
    • Necmettin Erbakan University

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: periodontitis	Diagnostic test: ELISA; ELISA(enzyme-linked immunosorbent assay)
Experimental: gingivitis	Diagnostic test: ELISA; ELISA(enzyme-linked immunosorbent assay)
Experimental: periodontal healthy	Diagnostic test: ELISA; 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	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	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	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	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

• Sponsor: Necmettin Erbakan University

Study record dates

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: periodontitis; saliva; sclerostin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• 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