Evaluation of Bone Metabolism Biomarkers in Periodontal Diseases

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

ELISA

About this trial

This is an interventional diagnostic trial for Periodontal Diseases focused on measuring periodontitis, saliva, sclerostin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Necmettin Erbakan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

periodontitis

gingivitis

periodontal healthy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT05702892

First Posted

January 9, 2023

Last Updated

January 18, 2023

Sponsor

Necmettin Erbakan University

1. Study Identification

Unique Protocol Identification Number

NCT05702892

Brief Title

Evaluation of Bone Metabolism Biomarkers in Periodontal Diseases

Official Title

Evaluation Of Biomarkers Associated With Bone Metabolism İn Patients With Different Periodontal Status

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

November 5, 2020 (Actual)

Primary Completion Date

May 5, 2021 (Actual)

Study Completion Date

November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Diseases

Keywords

periodontitis, saliva, sclerostin

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

periodontitis

Arm Type

Experimental

Arm Title

gingivitis

Arm Type

Experimental

Arm Title

periodontal healthy

Arm Type

Experimental

Intervention Type

Diagnostic Test

Intervention Name(s)

ELISA

Intervention Description

ELISA(enzyme-linked immunosorbent assay)

Primary Outcome Measure Information:

Title

Evaluation of bone metabolism biomarkers in different periodontal conditions

Description

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.

Time Frame

baseline

Secondary Outcome Measure Information:

Title

Probing pocket depth

Description

Probing pocket depth(PPD) was measured for determining the severity of the disease and clinical outcome. High probing depth shows more severe periodontal disease.

Time Frame

baseline

Title

Gingival index

Description

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.

Time Frame

baseline

Title

Plaque index

Description

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.

Time Frame

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Necmettin Erbakan University

City

Konya

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

No

Periodontal Diseases

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial