PeriodontitisEsCAPENCT02493270
Effect of Smoking Cessation on Non-surgical Periodontal Therapy
A study testing Smoking cessation therapy and Non-surgical periodontal therapy in people with Periodontitis, run by University of Sao Paulo.
Trial summary
The aim of this prospective study is to verify the efficacy of smoking cessation on non-surgical periodontal therapy in adult subjects with chronic periodontitis. Smokers that were 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 therapy and Non-surgical periodontal 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
- 177 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Jun 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
- subjects were willing to stop smoking
- >10 teeth
- periodontitis (30% or more of their teeth with proximal CAL ≥ 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 study is to verify the efficacy of smoking cessation on non-surgical periodontal therapy in adult subjects with chronic periodontitis.
Smokers that were willing to quit received periodontal treatment and concurrent smoking cessation therapy. Periodontal maintenance was performed every 3 months. A calibrated examiner, blinded to smoking status, assessed periodontal status, gathered demographic and behavioural information with a structured questionnaire and measured air carbon monoxide concentration measurements.
- Conditions
- Periodontitis
- Being tested
- Smoking cessation therapy, Non-surgical periodontal therapy
- Keywords
- smoking cessation, tobacco, dental, periodontal
- 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 therapyBehavioural
Multidisciplinary smoking cessation therapy, performed by a team comprising physicians, nurses, a psychologist and dentists. It consisted of four 1-h counselling lectures, psychologist-assisted cognitive behavioural 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
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
| Study group | Role | What they receive |
|---|---|---|
| Adjunctive smoking cessation | Experimental | non-surgical periodontal therapy and concurrent smoking cessation therapy Receives: Behavioral: Smoking cessation therapy; Procedure: Non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Attachment Level (millimeters) after 24 months
Measured: baseline and 24 months
Secondary outcomes (4)
Change in Gingival recession (millimeters) after 24 months
Measured: baseline and 24 months
Change in Pocket depth (millimeters) after 24 months
Measured: baseline and 24 months
Change in bleeding on probing (percentage of sites with bleeding) after 24 months
Measured: baseline and 24 months
Change in visible plaque (percentage of sites with visible plaque) after 24 months
Measured: baseline and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startMay 2007
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT02493270
- Sponsor's protocol ID
- EsCAPE
- Acronym
- EsCAPE
- Status last verified
- Apr 2016
- First submitted
- 2 Jul 2015
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosa EF, Corraini P, Inoue G, Gomes EF, Guglielmetti MR, Sanda SR, Lotufo JP, Romito GA, Pannuti CM. Effect of smoking cessation on non-surgical periodontal therapy: results after 24 months. J Clin Periodontol. 2014 Dec;41(12):1145-53. doi: 10.1111/jcpe.12313. Epub 2014 Nov 21.
PubMed 25265872Rosa EF, Corraini P, de Carvalho VF, Inoue G, Gomes EF, Lotufo JP, De Micheli G, Pannuti CM. A prospective 12-month study of the effect of smoking cessation on periodontal clinical parameters. J Clin Periodontol. 2011 Jun;38(6):562-71. doi: 10.1111/j.1600-051X.2011.01723.x. Epub 2011 Apr 13.
PubMed 21488933
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking Cessation on Non-surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT02493270
- Acronym / sponsor ID
- EsCAPE / EsCAPE
- Conditions
- Periodontitis
- Keywords
- smoking cessation, tobacco, dental, periodontal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Jul 2015 (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 study is to verify the efficacy of smoking cessation on non-surgical periodontal therapy in adult subjects with chronic periodontitis.
Smokers that were willing to quit received periodontal treatment and concurrent smoking cessation therapy. Periodontal maintenance was performed every 3 months. A calibrated examiner, blinded to smoking status, assessed periodontal status, gathered demographic and behavioural information with a structured questionnaire and measured air carbon monoxide concentration measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjunctive smoking cessation | Experimental | Behavioral: Smoking cessation therapy, Procedure: Non-surgical periodontal therapynon-surgical periodontal therapy and concurrent smoking cessation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects were willing to stop smoking
- >10 teeth
- periodontitis (30% or more of their teeth with proximal CAL ≥ 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 therapyMultidisciplinary smoking cessation therapy, performed by a team comprising physicians, nurses, a psychologist and dentists. It consisted of four 1-h counselling lectures, psychologist-assisted cognitive behavioural 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 | Behavioural | Adjunctive smoking cessation |
| 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 | Adjunctive smoking cessation |
Primary outcome
Change in Clinical Attachment Level (millimeters) after 24 months
Time frame: baseline and 24 months
4 secondary outcomes
Change in Gingival recession (millimeters) after 24 months
Time frame: baseline and 24 months
Change in Pocket depth (millimeters) after 24 months
Time frame: baseline and 24 months
Change in bleeding on probing (percentage of sites with bleeding) after 24 months
Time frame: baseline and 24 months
Change in visible plaque (percentage of sites with visible plaque) after 24 months
Time frame: baseline and 24 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 15 Apr 2016.
- Results publication: PubMed 25265872Rosa EF, Corraini P, Inoue G, Gomes EF, Guglielmetti MR, Sanda SR, Lotufo JP, Romito GA, Pannuti CM. Effect of smoking cessation on non-surgical periodontal therapy: results after 24 months. J Clin Periodontol. 2014 Dec;41(12):1145-53. doi: 10.1111/jcpe.12313. Epub 2014 Nov 21.
- Results publication: PubMed 21488933Rosa EF, Corraini P, de Carvalho VF, Inoue G, Gomes EF, Lotufo JP, De Micheli G, Pannuti CM. A prospective 12-month study of the effect of smoking cessation on periodontal clinical parameters. J Clin Periodontol. 2011 Jun;38(6):562-71. doi: 10.1111/j.1600-051X.2011.01723.x. Epub 2011 Apr 13.
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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 therapy and Non-surgical periodontal therapy in people with Periodontitis, run by University of Sao Paulo.
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 15 Apr 2016. 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 (millimeters) after 24 months (time frame: baseline and 24 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 NCT02493270, which also lists 2 linked publications.
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 15 Apr 2016.