Determination of the Levels of Lipocalin-2 and Semaphorin3A

NCT ID: NCT04390997

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2021-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this clinical trial is to investigate the concentrations of Lipocalin-2 and Semaphorin 3A levels in gingival crevicular fluid in subjects with different periodontal diseases. At the same time for the periodontitis group; the purpose of this study is to analyze the correlation of these proteins with clinical parameters at the first and third months after the nonsurgical periodontal treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In our study, gingival crevicular fluid samples will be taken along with the measurement of all oral clinical parameters from sixty systemically healthy volunteers (20 periodontally healthy, 20 gingivitis, and 20 periodontitis). Gingival crevicular fluid samples will be taken again after the nonsurgical periodontal treatment for the periodontitis group in the first and third months. Lipocalin-2 and Semaphorin 3A levels will be determined by an enzyme-linked immunosorbent assay test (ELISA). Subsequent statistical analyses will be used to interpret protein levels among different groups and peridontitis group after the nonsurgical periodontal treatment.

Possible significant differences may illuminate the future work with Lipocalin-2 and Semaphorin 3A. Also, these glycoproteins may help to develop different diagnostic methods or treatment strategies for future periodontal treatments.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gingivitis Periodontitis Periodontal Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Periodontally Healthy

20 participants with bleeding on probing less than 10%, probing depths less than 4mm, and no clinical attachment loss which was measured by six sites per tooth

Group Type NO_INTERVENTION

No interventions assigned to this group

Gingivitis

20 participants with bleeding on probing greater than 10%, probing depths less than 4mm, and no clinical attachment loss which was measured by six sites per tooth

Group Type NO_INTERVENTION

No interventions assigned to this group

Periodontitis

20 participants with bleeding on probing greater than or equal to 30%, probing depths greater than or equal to 5mm at least non-adjacent two teeth in each quadrant of the dentition, and clinical attachment loss greater than or equal to 4mm which was measured by six sites per tooth, and radiographic bone loss on the coronal third of root or severe (vertical/ horizontal) bone loss.

Group Type OTHER

Non-surgical Periodontal Treatment

Intervention Type PROCEDURE

Non-surgical periodontal treatment includes scaling and root planning by using curettes and ultrasonic devices only in the periodontitis group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-surgical Periodontal Treatment

Non-surgical periodontal treatment includes scaling and root planning by using curettes and ultrasonic devices only in the periodontitis group.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being systemically healthy
* Having at least 20 teeth in the dentition, excluding third molars
* Not using alcohol nor smoking
* Not using medications
* Not taking any antibiotics, anti-inflammatory, nor systemic corticosteroid drugs in the last six months
* Not being in the lactation period nor pregnancy

Exclusion Criteria

* Having any oral or systemic diseases
* Using alcohol or smoking
* Using medications
* Taking any antibiotics, anti-inflammatory, or systemic corticosteroid drugs in the last six months
* Being in the lactation period or pregnancy
* Being treated with periodontal treatment in the last six months
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Izmir Katip Celebi University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Merve Ceylan

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Izmir Katip Celebi University, Faculty of Dentistry

Izmir, Cigli, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-TDU-DİSF-0009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.