Determination of the Levels of Lipocalin-2 and Semaphorin3A
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2019
CompletedFirst Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2021
CompletedFebruary 10, 2021
February 1, 2021
1.1 years
May 13, 2020
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The level of Lipocalin-2
Investigating the concentrations of Lipocalin-2 level in gingival crevicular fluid in subjects with different periodontal diseases.
18 months
The level of Semaphorin 3A
Investigating the concentrations of Semaphorin 3A leves in gingival crevicular fluid in subjects with different periodontal diseases.
18 months
Secondary Outcomes (1)
Effects of non-surgical periodontal treatment on the levels of Lipocalin-2 and Semaphorin3A
18 months
Study Arms (3)
Periodontally Healthy
NO INTERVENTION20 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
Gingivitis
NO INTERVENTION20 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
Periodontitis
OTHER20 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.
Interventions
Non-surgical periodontal treatment includes scaling and root planning by using curettes and ultrasonic devices only in the periodontitis group.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Izmir Katip Celebi University, Faculty of Dentistry
Izmir, Cigli, 35640, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 18, 2020
Study Start
November 15, 2019
Primary Completion
December 15, 2020
Study Completion
January 15, 2021
Last Updated
February 10, 2021
Record last verified: 2021-02