Back to resultsThe Effect of Smoking and Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Cyclophilin A and EMMPRIN Levels
Primary Purpose
Smoking, Periodontitis, Non-surgical Periodontal Treatment
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
non-surgical periodontal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Smoking
Eligibility Criteria
Inclusion Criteria:
- generalized periodontitis with stage III-IV & Grade B
- no systemic and periodontal diseases
- smokers (minimum 10 cigarettes per day for at least ten years)
- non-smokers (never smoked)
Exclusion Criteria:
- Systemic diseases
- Infectious diseases
- Pregnancy or lactating
- Having periodontal treatment during the last 6 months
- Having antibiotic treatment within the past 3 months
- Former smokers
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
smoker
non-smoker
Arm Description
Outcomes
Primary Outcome Measures
Change in gingival crevicular fluid CypA total amounts
GCF CyPA levels were analyzed by ELISA
Change in gingival crevicular fluid EMMPRIN total amounts
GCF EMMPRIN levels were analyzed by ELISA
Secondary Outcome Measures
Change in probing depth
Probing depth was measured with Williams periodontal probe.
Change in bleeding on probing
Bleeding on probing was evaluated the presence or absense following bleeding upon probing.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04430764
Brief Title
The Effect of Smoking and Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Cyclophilin A and EMMPRIN Levels
Official Title
The Effect of Smoking and Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Cyclophilin A and EMMPRIN Levels
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
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
This study aimed to investigate the effect of smoking and non-surgical periodontal treatment on gingival crevicular fluid CyPA and EMMPRIN levels in patients with periodontitis. Twenty-eight patients with periodontitis (14 non-smoker and 14 smoker) and 30 control subjects (15 non-smoker and 15 smoker) were included into the study. Non-surgical periodontal treatment was applied to all periodontitis patients. Periodontal parameters and GCF CyPA and EMMPRIN levels were evaluated during 3 months following non-surgical periodontal treatment. GCF CyPA and EMMPRIN levels were analyzed by ELISA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Periodontitis, Non-surgical Periodontal Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
smoker
Arm Type
Experimental
Arm Title
non-smoker
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
non-surgical periodontal treatment
Intervention Description
Non-surgical periodontal treatment program was as following: First, motivation and oral hygiene instructions were given to all participants with periodontitis. The modified-Bass tooth brushing technique with a given dentifrice and toothbrush twice a day, and dental flossing/ interdental brushing once a day was advised to all patients with periodontitis. Second, scaling using an ultrasonic device and root planning by hand instruments under local anesthesia was performed.
Primary Outcome Measure Information:
Title
Change in gingival crevicular fluid CypA total amounts
Description
GCF CyPA levels were analyzed by ELISA
Time Frame
Baseline, 1 week, 1., 3. months
Title
Change in gingival crevicular fluid EMMPRIN total amounts
Description
GCF EMMPRIN levels were analyzed by ELISA
Time Frame
Baseline, 1 week, 1., 3. months
Secondary Outcome Measure Information:
Title
Change in probing depth
Description
Probing depth was measured with Williams periodontal probe.
Time Frame
Baseline, 1., 3. months
Title
Change in bleeding on probing
Description
Bleeding on probing was evaluated the presence or absense following bleeding upon probing.
Time Frame
Baseline, 1., 3. months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
generalized periodontitis with stage III-IV & Grade B
no systemic and periodontal diseases
smokers (minimum 10 cigarettes per day for at least ten years)
non-smokers (never smoked)
Exclusion Criteria:
Systemic diseases
Infectious diseases
Pregnancy or lactating
Having periodontal treatment during the last 6 months
Having antibiotic treatment within the past 3 months
Former smokers
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Smoking and Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Cyclophilin A and EMMPRIN Levels
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