Evaluation of Bone Metabolism Biomarkers in Periodontal Diseases

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Diagnostic Test: ELISA

• Registration Number: NCT05702892
• Lead Sponsor: Necmettin Erbakan University

Brief Summary

This study evaluates the levels of biomarkers associated with bone metabolism in patients with different periodontal conditions.

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 Timeline

• Study Start: 2020-11-05
• Primary Completion: 2021-05-05
• Study Completion: 2021-11-05
• Status Verified: 2023-01
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-18
• Last Update Submitted: 2023-01-18
• Study First Posted: 2023-01-27
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
periodontal healthy	ELISA	-
gingivitis	ELISA	-
periodontitis	ELISA	-

Primary Outcome Measures

Name	Time	Method
Evaluation of bone metabolism biomarkers in different periodontal conditions	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.

Secondary Outcome Measures

Name	Time	Method
Probing pocket depth	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.
Plaque index	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.
Gingival index	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.

Trial Locations

Locations (1)

Necmettin Erbakan University; 🇹🇷 Konya, Turkey