Back to resultsResolvin D1 Levels in Patients With Periodontitis
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
periodontal therapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Periodontitis focused on measuring gingival crevicular fluid, resolvin D1
Eligibility Criteria
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.
Sites / Locations
- Ordu University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Periodontitis patients
Healthy individuals
Arm Description
gingival crevicular fluid and saliva collection were taken before and after nonsurgical periodontal treatment
gingival crevicular fluid and saliva collection were taken at baseline after oral hygiene instructions
Outcomes
Primary Outcome Measures
Biochemical parameter (resolvin D1)
The changes in levels of resolvin D1 after periodontal treatment determined by ELISA.
Secondary Outcome Measures
Probing pocket depth
The changes in probing pocket depth after periodontal treatment were evaluated
Clinical attachment level (CAL)
The changes in CAL after periodontal treatment were evaluated
Plaque index (PI)
The changes in PI after periodontal treatment were evaluated
Gingival index (GI)
The changes in GI after periodontal treatment were evaluated
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04496570
Brief Title
Resolvin D1 Levels in Patients With Periodontitis
Official Title
The Role of Resolvin D1 in Maintaining Oral Health
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
T.C. ORDU ÜNİVERSİTESİ
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
gingival crevicular fluid, resolvin D1
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Periodontitis patients
Arm Type
Active Comparator
Arm Description
gingival crevicular fluid and saliva collection were taken before and after nonsurgical periodontal treatment
Arm Title
Healthy individuals
Arm Type
No Intervention
Arm Description
gingival crevicular fluid and saliva collection were taken at baseline after oral hygiene instructions
Intervention Type
Procedure
Intervention Name(s)
periodontal therapy
Intervention Description
Non surgical periodontal therapy was performed to patients with peridontitis
Primary Outcome Measure Information:
Title
Biochemical parameter (resolvin D1)
Description
The changes in levels of resolvin D1 after periodontal treatment determined by ELISA.
Time Frame
Baseline and 1 month after NSPT
Secondary Outcome Measure Information:
Title
Probing pocket depth
Description
The changes in probing pocket depth after periodontal treatment were evaluated
Time Frame
Baseline and 1 month after NSPT
Title
Clinical attachment level (CAL)
Description
The changes in CAL after periodontal treatment were evaluated
Time Frame
Baseline and 1 month after NSPT
Title
Plaque index (PI)
Description
The changes in PI after periodontal treatment were evaluated
Time Frame
Baseline and 1 month after NSPT
Title
Gingival index (GI)
Description
The changes in GI after periodontal treatment were evaluated
Time Frame
Baseline and 1 month after NSPT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ordu University
City
Ordu
ZIP/Postal Code
52200
Country
Turkey
12. IPD Sharing Statement
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Resolvin D1 Levels in Patients With Periodontitis
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