The Effect of Smoking and Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Cyclophilin A and EMMPRIN Levels
1 other identifier
interventional
58
0 countries
N/A
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.
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 Oct 2014
Shorter than P25 for not_applicable
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
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedJune 12, 2020
June 1, 2020
10 months
June 9, 2020
June 11, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change in gingival crevicular fluid CypA total amounts
GCF CyPA levels were analyzed by ELISA
Baseline, 1 week, 1., 3. months
Change in gingival crevicular fluid EMMPRIN total amounts
GCF EMMPRIN levels were analyzed by ELISA
Baseline, 1 week, 1., 3. months
Secondary Outcomes (2)
Change in probing depth
Baseline, 1., 3. months
Change in bleeding on probing
Baseline, 1., 3. months
Study Arms (2)
smoker
EXPERIMENTALnon-smoker
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ege Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 12, 2020
Study Start
October 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
June 12, 2020
Record last verified: 2020-06