Determination of the Levels of Lipocalin-2 and Semaphorin3A

• Sponsor: Izmir Katip Celebi University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04390997
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Actual Duration (Months): 14
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gingivitis; Periodontitis; Periodontal Diseases	Procedure: Non-surgical Periodontal Treatment	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Determination of the Levels of Lipocalin-2 and Semaphorin3A in Gingival Crevicular Fluid in Subjects With Different Periodontal Diseases
• Actual Study Start Date: Nov 15, 2019
• Actual Primary Completion Date: Dec 15, 2020
• Actual Study Completion Date: Jan 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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
No Intervention: 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
Other: 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.	Procedure: Non-surgical Periodontal Treatment; Non-surgical periodontal treatment includes scaling and root planning by using curettes and ultrasonic devices only in the periodontitis group.

Outcome Measures

Primary Outcome Measures

1. The level of Lipocalin-2 [18 months]

   Investigating the concentrations of Lipocalin-2 level in gingival crevicular fluid in subjects with different periodontal diseases.

2. The level of Semaphorin 3A [18 months]

   Investigating the concentrations of Semaphorin 3A leves in gingival crevicular fluid in subjects with different periodontal diseases.

Secondary Outcome Measures

1. Effects of non-surgical periodontal treatment on the levels of Lipocalin-2 and Semaphorin3A [18 months]

   Analyzing the correlation of Lipocalin-2 and Semaphorin3A with clinical parameters at the first and third months after the nonsurgical periodontal treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Izmir Katip Celebi University, Faculty of Dentistry	Izmir	Cigli	Turkey	35640

Sponsors and Collaborators

• Izmir Katip Celebi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merve Ceylan, Research Assistant, Izmir Katip Celebi University
• ClinicalTrials.gov Identifier: NCT04390997
• Other Study ID Numbers: 2019-TDU-DİSF-0009
• First Posted: May 18, 2020
• Last Update Posted: Feb 10, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Merve Ceylan, Research Assistant, Izmir Katip Celebi University: Periodontal Disease, Non-surgical Periodontal Treatment, GCF
• Additional relevant MeSH terms: Gingivitis; Periodontitis; Periodontal Diseases

Study Results

No Results Posted as of Feb 10, 2021