NCT06727929

Brief Summary

Periodontitis is a condition that is defined by microbial-associated, host-induced inflammation, which ultimately results in the loss of periodontal attachment.Periodontal clinical parameters are the most reliable indicators of periodontal disease; however, they provide information about past tissue destruction and are insufficient for predicting future periodontal disease activity. Therefore, evaluation of Dickkopf-1 (Dkk-1) and secreted Frizzled related protein 5 (sFRP5), which are Wnt signaling pathway antagonists, in periodontal inflammation may be a focus of interest. A total of 99 individuals, 44 male and 55 female, participated in our study and were divided into three groups as periodontally healthy, gingivitis and periodontitis. Non-surgical periodontal treatment was applied to the disease groups. Dkk-1 and sFRP5 were evaluated in gingival crevicular fluid (GCF) at the baseline and after periodontal treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

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 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

December 4, 2024

Last Update Submit

March 17, 2026

Conditions

Keywords

Dickkopf-1secreted Frizzled Related Protein 5Gingival crevicular fluid

Outcome Measures

Primary Outcomes (1)

  • Dkk-1 and sFRP5 levels at baseline and after periodontal treatment

    Dkk-1 and sFRP5 levels assessed by ELISA in GCF at baseline and after non-surgical periodontal treatment were the primary outcome measures.Dkk-1 and sFRP5 will be measured by ELISA technique according to the manufacturer's instructions. The sensitivity value for Dkk-1 and sFRP5 is 0.056 ng/mL and 0.059 ng/mL, respectively. Optical densities will be taken at 450 nm wavelength, and standard concentrations and corresponding optical density values and sample optical density values will be recorded. The standard curve will be drawn according to the optical densities and concentrations of standards, and the concentrations of all samples will be calculated by the linear regression equation of the obtained standard curve.Dkk-1 and sFRP5 total amount will be given in ng unit.

    6-8 weeks

Secondary Outcomes (6)

  • Gingival Crevicular Fluid (GCF)Volume at baseline and after periodontal treatment

    6-8 weeks

  • Gingival index (GI) at baseline and after periodontal treatment

    6-8 weeks

  • Bleeding on probing (BOP) percentage at baseline and after periodontal treatment

    6-8 weeks

  • Probing depth (PD)at baseline and after periodontal treatment

    6-8 weeks

  • Plaque index (PI) at baseline and after periodontal treatment

    6-8 weeks

  • +1 more secondary outcomes

Study Arms (3)

Periodontally Healthy

PD ≤3 mm, fullmouth bleeding scores (BOP) % \<10, no CAL and radiologic bone loss

Diagnostic Test: Collection of gingival crevicular fluid, ELISA

Gingivitis

PD ≤3 mm, % BOP \>30, no CAL(due to periodontal disease) and radiologic bone loss

Diagnostic Test: Collection of gingival crevicular fluid, ELISA

Periodontitis

These individuals had a minimum of two non-adjacent teeth with sites with PD ≥6 mm, CAL ≥5 mm, BOP ≥30%, tooth loss due to periodontitis ≤4 teeth, the alveolar bone loss at radiographs extending to middle or apical third of the root, the presence of consistent amounts of plaque biofilm/calculus deposits commensurate with the severity of periodontal tissue breakdown, the proportion of percentage bone loss to age values were between 0.25 and 1

Diagnostic Test: Collection of gingival crevicular fluid, ELISA

Interventions

GCF samples were collected at baseline and at the 6-8 -week follow-up appointment after non-surgical periodontal treatment . After removing the supragingival plaque from the interproximal surfaces with sterile curettes, these sample surfaces were isolated with cotton rolls and slightly air-dried to avoid contamination. Standardized paper strips were inserted 1 to 2 mm into the gingival sulcus and held for 30 seconds to collect GCF. Strips contaminated with blood or saliva were discarded and not evaluated. The paper strips were transferred to a precalibrated Periotron 8000 device to measure the fluid volume. Paper strips were placed in sterile Eppendorf tubes and stored at -80C, until laboratory analysis. The level of GCF Dkk-1 and sFRP5 levels was measured by ELISA using commercial kits.

GingivitisPeriodontally HealthyPeriodontitis

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

A total of 99 patients (44 males and 55 females) between 20-50 years of age were included and were divided into three groups as follows: periodontally healthy, patients with gingivitis, and patients with stage 3 grade B periodontitis. Participants were selected from the patients who presented for periodontal treatment between March 2024 and August 2024 at Department of Periodontology, Faculty of Dentistry, Sivas Cumhuriyet University, Sivas, Turkey.

You may qualify if:

  • Being between 20-50 years old
  • Meeting the criteria for the working groups

You may not qualify if:

  • having any systemic or metabolic diseases or insturition of effected bone metabolism,
  • having bruksizm habits,
  • pregnant or lactating,
  • received periodontal/peri-implant treatment within the last 6 months,
  • the history of antibiotics or antiinflamatuars use regularly within the last 6 months,
  • having \< 20 teeth (except for 3rd molars),
  • smokers or consumed alcohol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alveolar Bone LossPeriodontal Diseases

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyMouth DiseasesStomatognathic Diseases

Study Officials

  • Şükran Acıpınar

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 11, 2024

Study Start

March 1, 2024

Primary Completion

November 1, 2024

Study Completion

January 1, 2025

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

It will be updated and shared upon completion of the study.

Locations