- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03901066
Smoking Dependence and Periodontitis
Smoking Dependence (Fagerström) as a Relevant Indicator for Tobacco Related Studies in Periodontology.
Study Overview
Status
Conditions
Detailed Description
The present study was designed as a, single-center, prospective cohort study focusing on the relationship between smoking status and the severity of periodontitis.
The research question was " How the Fagerström for nicotine dependence (FTND) and the number of cigarette cunsuption (NNC) are correlated to the severity of chronic periodontitis"? Thirty-four consecutive smoker patients presenting a chronic periodontitis were included in the study, and the smoking status was defined both by NCC and FTND.
Periodontal clinical parameters were correlated with NCC and FTND.
All the clinical periodontal parameters were recorded by a single periodontist (L.S). Periodontal assessments included: probing depth (PD), gingival recession (RD), clinical attachment level (CAL), bleeding on probing (BOP), plaque score index (PI), Furcation (Furc), tooth mobility and the percentage of sites of PD ≥ 6mm. A graduated manual periodontal probe was used to take measurements at the 6 sites of each tooth. BOP (%) and plaque score (%).
All the participants of the study respected the following inclusion criteria: 1/ smoker patients aged of minimum 18 years old, 2/ chronic periodontitis, 3/ presence of a minimum of 6 teeth at each arch, 4/ a minimum of 6 teeth with pocket depth of 5 mm, 5/ signed the informed consent. The exclusion criteria were: 1/ aggressive periodontitis, 2/ diabetes, 3/ connective tissue disease, 4/ pregnancy, 5/ radio-therapy, 6/ chemotherapy, 7/ psychological disease, 8/ previous periodontal therapy.
The patient smoking status was defined by FTND and NCC FTND scores were categorized in 3 groups
- scores < 4 for low nicotine dependence,
- scores = 4-5 for moderate nicotine dependence
- scores > 5 for high nicotine dependence.
The NCC s was classified in three levels of smokers as described in most of the periodontal studies:
- Number of cigarette smoking ≤ 10 per day for low consumption
- Number of cigarette smoking from 10 to 20 per day for moderate consumption
- Number of cigarette smoking > 20 per day for high cigarette consumption
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- smoker patients aged of minimum 18 years old
- chronic periodontitis
- presence of a minimum of 6 teeth at each arch
- a minimum of 6 teeth with pocket depth of 5 mm
- signed the informed consent
Exclusion Criteria:
- aggressive periodontitis
- diabetes
- connective tissue disease
- pregnancy
- radio-therapy
- chemotherapy
- psychological disease
- previous periodontal therapy.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effect of nicotine dependence level on periodontal outcomes
Time Frame: 1 day
|
effect of nicotine dependence score on pocket depth (PD)
|
1 day
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- File number: B707201419816
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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