PeriodontitisEsCAPE2NCT02744417
Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy
A study testing Smoking cessation counseling, Non-surgical periodontal therapy and Nicotine replacement therapy in people with Periodontitis, run by Claudio Mendes Pannuti.
Trial summary
The aim of this prospective interventional study is to verify the efficacy of smoking cessation on clinical and microbiological outcomes of non-surgical periodontal therapy of chronic periodontitis patients. Smokers willing to quit received periodontal treatment and concurrent smoking cessation therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Smoking cessation counseling, Non-surgical periodontal therapy and Nicotine replacement therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Mar 2014
- Phase
- Interventional
- 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
Who may be able to join
- smokers willing to stop smoking
- >10 teeth
- periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm)
Who cannot join
- systemic conditions considered as risk factors for periodontal disease,
- periodontal therapy in the last 6 months
- continuous systemic use of anti-inflammatory or steroidal drugs
About this study
The aim of this prospective interventional study is to verify the efficacy of smoking cessation on clinical and microbiological outcomes of non-surgical periodontal therapy of chronic periodontitis patients. Smokers willing to quit received periodontal treatment and concurrent smoking cessation therapy. Periodontal maintenance was performed every 3 months. A single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes and applied a structured questionnaire in order to collect demographic and behavioural information. Further, expired carbon monoxide concentration were measured with a monoximeter. A pooled subgingival plaque sample was collected from the deepest periodontal pocket from each participant. The presence and quantification of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola were determined using (RT-PCR).
Read the detailed description
Smokers willing to quit, with 10 teeth or more, and with periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm) were enrolled in the study. All subjects received periodontal treatment and concurrent smoking cessation therapy. Smoking cessation therapy was performed by a team comprising physicians, nurses, a psychologist and dentists, and consisted of four 1-h counselling lectures, psychologist-assisted cognitive behavioral therapy, nicotine replacement therapy and medication (bupropion or varenicline). Smoking cessation motivation was reinforced by dentists at the maintenance sessions, by means of motivational interviewing techniques. Periodontal therapy consisted in full-mouth supra and subgingival scaling and root planing (with curettes and ultrasonic scaler); oral hygiene instruction and motivation and removal of intra-oral plaque retentive factors. Further, periodontal maintenance was performed every 3 months.
A single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes (recession, pocket depth, clinical attachment level, plaque index and bleeding on probing). A structured questionnaire was applied in order to collect demographic and behavioral information. Expired carbon monoxide concentration was measured with a monoximeter, in order to validate smoking status. A pooled subgingival plaque sample was collected from the deepest periodontal pocket from each participant. The presence and quantification of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola were determined using real time - PCR (RT-PCR).
- Conditions
- Periodontitis
- Being tested
- Smoking cessation counseling, Non-surgical periodontal therapy, Nicotine replacement therapy, bupropion hydrochloride, Varenicline
- Keywords
- smoking cessation, tobacco, periodontal, subgingival microorganisms
- Medical subject headings
- Periodontitis, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation counselingBehavioural
Multidisciplinary smoking cessation counseling, performed by a team comprising physicians, nurses, a psychologist and dentists. It consisted of four 1-h counselling lectures delivered by physicians, psychologist-assisted cognitive behavioural therapy, and counseling provided by dentists during the active phase of the treatment and maintenance session, using motivational interviewing techniques
Non-surgical periodontal therapyProcedure or surgery
Full-mouth supra and subgingival scaling and root planing (with curettes and ultrasonic scaler); oral hygiene instruction and motivation and removal of intra-oral plaque retentive factors
Nicotine replacement therapyDrug
Also called Nicorette
Nicotine replacement therapy: chewing gum (Nicorette chewing gum 2-4mg) and patches (Nicorette patches 15-25mg)
bupropion hydrochlorideDrug
Also called Zyban
bupropion hydrochloride 150mg
VareniclineDrug
Also called Champix
Varenicline 0,5mg
| Study group | Role | What they receive |
|---|---|---|
| Smoking cessation therapy | Experimental | Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline Receives: Behavioral: Smoking cessation counseling; Procedure: Non-surgical periodontal therapy; Drug: Nicotine replacement therapy; Drug: bupropion hydrochloride; Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Attachment Level
Change in Clinical Attachment Level (millimeters) after 12 months
Measured: baseline - 12 months
Secondary outcomes (8)
Change in Gingival recession
Change in Gingival recession (millimeters) after 12 months
Measured: baseline - 12 months
Change in Pocket depth
Change in Pocket depth (millimeters) after 12 months
Measured: baseline - 12 months
Change in bleeding on probing
Change in bleeding on probing (percentage of sites with bleeding) after 12 months
Measured: baseline - 12 months
Change in visible plaque
Change in visible plaque (percentage of sites with visible plaque) after 12 months
Measured: baseline - 12 months
Prevalence and levels of Aggregatibacter actinomycetemcomitans
Prevalence and levels of Aggregatibacter actinomycetemcomitans determined by means of (RT-PCR).
Measured: baseline - 12 months
Prevalence and levels of Porphyromonas gingivalis
Prevalence and levels of Porphyromonas gingivalis, determined by means of (RT-PCR).
Measured: baseline - 12 months
Prevalence and levels of Tannerella forsythia
Prevalence and levels of Tanerella forsythia, determined by means of RT-PCR
Measured: baseline - 12 months
Prevalence and levels of Treponema denticola
Prevalence and levels of Treponema denticola, determined by means of RT-PCR
Measured: baseline - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startAug 2010
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudio Mendes Pannuti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudio Mendes Pannuti, University of Sao Paulo
- Investigators
- Claudio M Pannuti, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744417
- Sponsor's protocol ID
- EsCAPE2
- Acronym
- EsCAPE2
- Status last verified
- Nov 2018
- First submitted
- 13 Apr 2016
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Guglielmetti MR, Rosa EF, Lourencao DS, Inoue G, Gomes EF, De Micheli G, Mendes FM, Hirata RD, Hirata MH, Pannuti CM. Detection and quantification of periodontal pathogens in smokers and never-smokers with chronic periodontitis by real-time polymerase chain reaction. J Periodontol. 2014 Oct;85(10):1450-7. doi: 10.1902/jop.2014.140048. Epub 2014 May 2.
PubMed 24794687
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT02744417
- Acronym / sponsor ID
- EsCAPE2 / EsCAPE2
- Conditions
- Periodontitis
- Keywords
- smoking cessation, tobacco, periodontal, subgingival microorganisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Claudio Mendes PannutiUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Apr 2016 (estimated)
- 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 aim of this prospective interventional study is to verify the efficacy of smoking cessation on clinical and microbiological outcomes of non-surgical periodontal therapy of chronic periodontitis patients. Smokers willing to quit received periodontal treatment and concurrent smoking cessation therapy. Periodontal maintenance was performed every 3 months. A single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes and applied a structured questionnaire in order to collect demographic and behavioural information. Further, expired carbon monoxide concentration were measured with a monoximeter. A pooled subgingival plaque sample was collected from the deepest periodontal pocket from each participant. The presence and quantification of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola were determined using (RT-PCR).
Detailed description
Smokers willing to quit, with 10 teeth or more, and with periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm) were enrolled in the study. All subjects received periodontal treatment and concurrent smoking cessation therapy. Smoking cessation therapy was performed by a team comprising physicians, nurses, a psychologist and dentists, and consisted of four 1-h counselling lectures, psychologist-assisted cognitive behavioral therapy, nicotine replacement therapy and medication (bupropion or varenicline). Smoking cessation motivation was reinforced by dentists at the maintenance sessions, by means of motivational interviewing techniques. Periodontal therapy consisted in full-mouth supra and subgingival scaling and root planing (with curettes and ultrasonic scaler); oral hygiene instruction and motivation and removal of intra-oral plaque retentive factors. Further, periodontal maintenance was performed every 3 months.
A single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes (recession, pocket depth, clinical attachment level, plaque index and bleeding on probing). A structured questionnaire was applied in order to collect demographic and behavioral information. Expired carbon monoxide concentration was measured with a monoximeter, in order to validate smoking status. A pooled subgingival plaque sample was collected from the deepest periodontal pocket from each participant. The presence and quantification of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola were determined using real time - PCR (RT-PCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking cessation therapy | Experimental | Behavioral: Smoking cessation counseling, Procedure: Non-surgical periodontal therapy, Drug: Nicotine replacement therapy, Drug: bupropion hydrochloride, Drug: VareniclineNon-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- smokers willing to stop smoking
- >10 teeth
- periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm)
Key exclusion criteria (3 listed)
- systemic conditions considered as risk factors for periodontal disease,
- periodontal therapy in the last 6 months
- continuous systemic use of anti-inflammatory or steroidal drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation counselingMultidisciplinary smoking cessation counseling, performed by a team comprising physicians, nurses, a psychologist and dentists. It consisted of four 1-h counselling lectures delivered by physicians, psychologist-assisted cognitive behavioural therapy, and counseling provided by dentists during the active phase of the treatment and maintenance session, using motivational interviewing techniques | Behavioural | Smoking cessation therapy |
| Non-surgical periodontal therapyFull-mouth supra and subgingival scaling and root planing (with curettes and ultrasonic scaler); oral hygiene instruction and motivation and removal of intra-oral plaque retentive factors | Procedure or surgery | Smoking cessation therapy |
| Nicotine replacement therapyAlso: NicoretteNicotine replacement therapy: chewing gum (Nicorette chewing gum 2-4mg) and patches (Nicorette patches 15-25mg) | Drug | Smoking cessation therapy |
| bupropion hydrochlorideAlso: Zybanbupropion hydrochloride 150mg | Drug | Smoking cessation therapy |
| VareniclineAlso: ChampixVarenicline 0,5mg | Drug | Smoking cessation therapy |
Primary outcome
Change in Clinical Attachment Level
Time frame: baseline - 12 months
Change in Clinical Attachment Level (millimeters) after 12 months
8 secondary outcomes
Change in Gingival recession
Time frame: baseline - 12 months
Change in Pocket depth
Time frame: baseline - 12 months
Change in bleeding on probing
Time frame: baseline - 12 months
Change in visible plaque
Time frame: baseline - 12 months
Prevalence and levels of Aggregatibacter actinomycetemcomitans
Time frame: baseline - 12 months
Prevalence and levels of Porphyromonas gingivalis
Time frame: baseline - 12 months
Prevalence and levels of Tannerella forsythia
Time frame: baseline - 12 months
Prevalence and levels of Treponema denticola
Time frame: baseline - 12 months
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 6 Nov 2018.
- Results publication: PubMed 24794687Guglielmetti MR, Rosa EF, Lourencao DS, Inoue G, Gomes EF, De Micheli G, Mendes FM, Hirata RD, Hirata MH, Pannuti CM. Detection and quantification of periodontal pathogens in smokers and never-smokers with chronic periodontitis by real-time polymerase chain reaction. J Periodontol. 2014 Oct;85(10):1450-7. doi: 10.1902/jop.2014.140048. Epub 2014 May 2.
- Individual participant dataSharing planned: No
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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.
Claudio M Pannuti, PhD principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation counseling, Non-surgical periodontal therapy and Nicotine replacement therapy in people with Periodontitis, run by Claudio Mendes Pannuti.
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 3 inclusion and 3 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 6 Nov 2018. 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?
Change in Clinical Attachment Level (time frame: baseline - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744417, which also lists 1 linked publication.
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 6 Nov 2018.