NCT05702892

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

January 9, 2023

Last Update Submit

January 18, 2023

Conditions

Keywords

periodontitissalivasclerostin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Probing pocket depth

    baseline

  • Gingival index

    baseline

  • Plaque index

    baseline

Study Arms (3)

periodontitis

EXPERIMENTAL
Diagnostic Test: ELISA

gingivitis

EXPERIMENTAL
Diagnostic Test: ELISA

periodontal healthy

EXPERIMENTAL
Diagnostic Test: ELISA

Interventions

ELISADIAGNOSTIC_TEST

ELISA(enzyme-linked immunosorbent assay)

gingivitisperiodontal healthyperiodontitis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old.
  • not having any systemic disease that may affect periodontal status
  • not smoking and alcohol use
  • volunteer to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitisSclerosteosis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master in science

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 27, 2023

Study Start

November 5, 2020

Primary Completion

May 5, 2021

Study Completion

November 5, 2021

Last Updated

January 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations