Evaluation of Bone Metabolism Biomarkers in Periodontal Diseases

Sponsor
Necmettin Erbakan University (Other)
Overall Status
Completed
CT.gov ID
NCT05702892
Collaborator
(none)
60
1
3
12
5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ELISA
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation Of Biomarkers Associated With Bone Metabolism İn Patients With Different Periodontal Status
Actual Study Start Date :
Nov 5, 2020
Actual Primary Completion Date :
May 5, 2021
Actual Study Completion Date :
Nov 5, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Necmettin Erbakan University Konya Turkey

Sponsors and Collaborators

  • Necmettin Erbakan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ummuhan Tekin Atay, master in science, Necmettin Erbakan University
ClinicalTrials.gov Identifier:
NCT05702892
Other Study ID Numbers:
  • Ummuhan.tekinatay
First Posted:
Jan 27, 2023
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ummuhan Tekin Atay, master in science, Necmettin Erbakan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2023