SmokingNCT03901066
Smoking Dependence and Periodontitis
An observational study of Smoking and Periodontitis, run by University of Liege.
Trial summary
The present study was designed as a, single-center, prospective cohort study focusing on the relationship between smoking status and the severity of periodontitis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Periodontitis
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2014to Jul 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 34 consecutive smoker patients presenting periodontitis were included from the Department of Periodontology and Oral Surgery at the University of Liege, Belgium. All the participants of the study respected the aboveinclusion criteria
Who may be able to join
- 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
Who cannot join
- aggressive periodontitis
- diabetes
- connective tissue disease
- pregnancy
- radio-therapy
- chemotherapy
- psychological disease
- previous periodontal therapy.
About this study
Official title: Smoking Dependence (Fagerström) as a Relevant Indicator for Tobacco Related Studies in Periodontology.
The present study was designed as a, single-center, prospective cohort study focusing on the relationship between smoking status and the severity of periodontitis
Read the 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
- Conditions
- Smoking, Periodontitis
- Medical subject headings
- Smoking, Periodontitis
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of nicotine dependence level on periodontal outcomes
effect of nicotine dependence score on pocket depth (PD)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start3 Sep 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Salhi, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901066
- Sponsor's protocol ID
- File number: B707201419816
- Status last verified
- Apr 2019
- First submitted
- 22 Mar 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Dependence (Fagerström) as a Relevant Indicator for Tobacco Related Studies in Periodontology.
- ClinicalTrials.gov ID
- NCT03901066
- Acronym / sponsor ID
- File number: B707201419816
- Conditions
- Smoking, Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 3 Sep 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study was designed as a, single-center, prospective cohort study focusing on the relationship between smoking status and the severity of periodontitis
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 34 consecutive smoker patients presenting periodontitis were included from the Department of Periodontology and Oral Surgery at the University of Liege, Belgium. All the participants of the study respected the aboveinclusion criteria
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- aggressive periodontitis
- diabetes
- connective tissue disease
- pregnancy
- radio-therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
effect of nicotine dependence level on periodontal outcomes
Time frame: 1 day
effect of nicotine dependence score on pocket depth (PD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Periodontitis, run by University of Liege.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of nicotine dependence level on periodontal outcomes (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.