- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04496570
Resolvin D1 Levels in Patients With Periodontitis
The Role of Resolvin D1 in Maintaining Oral Health
The purpose of the study was to determine the levels of Resolvin D1 (RVD1) in the gingival crevicular fluid (GCF) and saliva of the patients with periodontitis (P) and also to investigate the effects of non-surgical periodontal treatments (NSPTs) on its levels.
A total of 26 subjects (15 P, 11 healthy) were included. Clinical periodontal measurements, GCF and saliva samples were collected from each individual at baseline and 1 month after NSPTs in P group. RVD1 levels were determined by enzyme-linked immunosorbent assay (ELISA) method.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ordu, Turkey, 52200
- Ordu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Stage 3, Grade B and generalized periodontitis patients
Exclusion Criteria:
- excessive forces;
- presence of systemic diseases
- administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies within the previous 6 months
- having received non-surgical periodontal treatment within the past 6 months
- allergy or sensitivity to any drug,
- pregnancy, lactation
- current and former use of tobacco.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Periodontitis patients
gingival crevicular fluid and saliva collection were taken before and after nonsurgical periodontal treatment
|
Non surgical periodontal therapy was performed to patients with peridontitis
|
NO_INTERVENTION: Healthy individuals
gingival crevicular fluid and saliva collection were taken at baseline after oral hygiene instructions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical parameter (resolvin D1)
Time Frame: Baseline and 1 month after NSPT
|
The changes in levels of resolvin D1 after periodontal treatment determined by ELISA.
|
Baseline and 1 month after NSPT
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing pocket depth
Time Frame: Baseline and 1 month after NSPT
|
The changes in probing pocket depth after periodontal treatment were evaluated
|
Baseline and 1 month after NSPT
|
Clinical attachment level (CAL)
Time Frame: Baseline and 1 month after NSPT
|
The changes in CAL after periodontal treatment were evaluated
|
Baseline and 1 month after NSPT
|
Plaque index (PI)
Time Frame: Baseline and 1 month after NSPT
|
The changes in PI after periodontal treatment were evaluated
|
Baseline and 1 month after NSPT
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Gingival index (GI)
Time Frame: Baseline and 1 month after NSPT
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The changes in GI after periodontal treatment were evaluated
|
Baseline and 1 month after NSPT
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ordu University Dental Faculty
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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