NCT05862311

Brief Summary

In this study, it was concluded that sclerostin and irisin may be alternative markers for evaluating the effectiveness of periodontal treatment and healing of periodontal tissues by affecting bone metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 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

March 12, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

April 16, 2023

Last Update Submit

May 7, 2023

Conditions

Periodontal Diseases

Keywords

Gingival Crevicular FluidIrisinPeriodontitisSclerostin

Outcome Measures

Primary Outcomes (1)

  • Evaluation of bone metabolism biomarkers in different periodontal conditions

    The levels of bone metabolism markers (such as sclerostin, irisin, IL-6, TNF-a, RANKL/OPG) in the gingival crevicular fluid of individuals with different periodontal conditions were compared using the ELISA (Enzyme Linked İmmünosorbent Assay) test, 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 (2)

systemically healthy and periodontitis

EXPERIMENTAL
Diagnostic Test: ELISA

type 2 diabetes and periodontitis

EXPERIMENTAL
Diagnostic Test: ELISA

Interventions

ELISADIAGNOSTIC_TEST

ELISA(enzyme-linked immunosorbent assay)

systemically healthy and periodontitistype 2 diabetes and periodontitis

Eligibility Criteria

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

You may qualify if:

  • Having at least 20 teeth in the mouth, excluding the third molars,
  • Individuals between the ages of 18-65
  • Diagnosed as stage 2 or stage 3 periodontitis as a result of periodontal examination
  • Those who do not have predisposing factors (restoration, caries, etc.)

You may not qualify if:

  • Smoking or using alcohol,
  • Any periodontal treatment performed in the last 6 months,
  • Being in pregnancy and/or lactation period,
  • Individuals who had received any anti-inflammatory, antibiotic, antioxidant or corticosteroid treatment in the last 6 months and refused to participate in the study were excluded from the study.

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
principal investigator

Study Record Dates

First Submitted

April 16, 2023

First Posted

May 17, 2023

Study Start

March 12, 2020

Primary Completion

September 12, 2020

Study Completion

March 12, 2021

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)