Periodontal DiseaseNCT02581319
Clinical Conditions and Prevalence of Periodontopathogens in Smokers and Non-smokers After Periodontal Therapy
A study testing Periodontal treatment in people with Periodontal Disease and Smoking, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Smoking has been considered the most important risk factor for periodontitis among all lifestyle factors. Fewer studies evaluated longitudinal clinical and microbiological status of smokers undergoing periodontal maintenance therapy and controversial results were found. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Smoking
- What is being tested?
- Periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Apr 2016
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- presence of periodontal disease in unirradicular teeth
- bleeding on probing in sites where probing depth was ≥5 mm in a minimum of two teeth in different arch;
- radiographic bone loss ranging from 30% to 50%.
Who cannot join
- patients with systemic diseases, diabetes; osteoporosis;
- pregnant lactating females;
- use of immune suppressive medication, phenytoin, cyclosporine, calcium channel blockers or any use of antibiotics or nonsteroidal anti-inflammatory drugs in the past 3 months;
- any medical conditions requiring immunotherapy or diagnosed as HIV+ or with AIDS, that could interfere with the periodontium status.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal Fluminense University
Nova Friburgo, Rio de Janeiro, 28625-650
Gabriela AC Camargo, PhD, +55 22 2528-7168, gaby.3003@hotmail.com
About this study
Smoking has been considered the most important risk factor for periodontitis among all lifestyle factors. Fewer studies evaluated longitudinal clinical and microbiological status of smokers undergoing periodontal maintenance therapy and controversial results were found. This study will evaluate clinical conditions and prevalence of putative periodontopathogens and Candida spp. in smokers and non-smokers at baseline and after 3 and 6 months of nonsurgical periodontal therapy. Clinical parameters, including oral status assessed using Plaque Index (PI), Bleeding On Probe (BOP), Pocket Probing Depth (PPD), Gingival Recession (GR), Clinical Attachment Level (CAL) will be measured in smokers and non-smokers patients with chronic periodontitis. Samples of subgingival biofilm will be obtained from the periodontal pockets and furcation sites and submitted to phenol-chloroform DNA extraction and Polymerase Chain Reaction (PCR) analysis using specific primers for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Campylobacter rectus, Candida albicans, Candida glabrata, Candida tropicalis and Candida dublinienses.
Read the detailed description
Sixty patients (30 smokers (SM) and 30 non-smokers (NS) will be selected to participate of this study. All subjects will be recruited from the Department of Periodontology, School of Dentistry, Fluminense Federal University, Nova Friburgo, Rio de Janeiro State, Brazil. The study protocol was approved (protocol number: CAAE - 0070.0.258.000-10) by the Ethics Committee of the School of Medicine, Fluminense Federal University. Prior to participation, the purpose and procedures will be fully explained to all patients, who consequently gave written informed consent in accordance with the Helsinki Declaration. Medical and dental histories will be taken and patients will receive clinical evaluation at prescreening visits.
Clinical examination, microbiological collects and periodontal therapy Previous clinical examination, information about years of consumption of cigars and quantity of daily consumption will be recorded to select smokers and non- smokers subjects for the study. An experienced periodontist will perform clinical periodontal parameters in teeth for the protocol procedure. Each selected tooth selected will be measured for: Plaque Index (PI), Bleeding On Probe (BOP), Pocket Probing Depth (PPD), Gingival Recession (GR), Clinical Attachment Level (CAL) using a periodontal probe PCP15 (PCP-UNC15, Hu-Friedy, Chicago, IL), six sites (mesio-buccal, mediobuccal, disto-buccal, mesio-lingual, medio-lingual, disto-lingual) will be recorded. Sites with probing depth (PPD) > 5mm will be selected for microbiological analysis. After clinical measurements, the supragingival biofilm will be removed with sterile gauze. Gingival crevicular samples will be taken from 4 sites with the deepest PPD (>5mm) in each patient using a sterile paper point from the deepest pocket for 30s. Pooled biofilms from each site will be separated in two microtubes containing Tris -EDTA buffer (10 mM Tris-Hcl, 0.1 mM EDTA, pH 7.5) and were stored at -20°C. The samples will be analyzed microbiologically by Polymerase Chain Reaction - PCR. Periodontal treatment will be consisted of scaling and planning root, 4 times in first month and after that once a month until complete 1 year. Patients will be clinically evaluated and microbiological collects will be made at baseline, 3 months, 6 months and 1 year after periodontal treatment.
Microbiological evaluation - PCR assays DNA will be extracted and quantified in a spectrophotometer at 260 nm (Genesys 10UV, Rochester, NY, USA), in order to obtain a standard concentration of 100 ng/mL and stored at -20 °C for subsequent PCR reactions. Briefly, samples will be submitted to a lise solution (extraction buffer and proteinase K) and then purified using chloroform:isoamil-alcohol, followed by DNA precipitation with isopropanol and 70% ethanol. The DNA will be resuspended in TE buffer (10 mM Tris-HCl, 0.1 mM EDTA, pH 7.5, with 10 μg/mL RNAse). Microbial molecular identification will be carried out by PCR with specific primers for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Campylobacter rectus, Candida albicans, Candida glabrata, Candida tropicalis and Candida dublinienses. PCR amplification will be performed with a GeneAmp PCR system 2400 (Perkin-Elmer - Applied Biosystems) for TGradient 96 (Biometra, Germany) under thermal conditions specific for each pair of primers. The PCR products will be separated by electrophoresis in 2% agarose gels and Tris-borate-EDTA running buffer (pH 8.0). The molecular mass ladder (100 bp DNA ladder, Gibco, Grand Island, NY, USA) will be included for running in the agarose gel. The DNA will be stained with 0.1µl of Sybr Safe/mL (Invitrogen, CA, USA) and visualized under UV illumination (Pharmacia LKB-MacroVue, San Gabriel, CA, USA). Photographs of the images will be taken (Image Mater - LISCAP, VDS, Pharmacia Biotech Piscataway, NJ, USA) and analyzed.
- Conditions
- Periodontal Disease, Smoking
- Being tested
- Periodontal treatment
- Medical subject headings
- Periodontal Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal treatmentProcedure or surgery
Also called Scaling and planning root
Periodontal treatment will consist of scaling and planning root, 4 times in the first month and after that once a month until complete one year. Patients will be clinically evaluated and microbiological collects were made at baseline, 3 months, 6 months and 1 year after periodontal treatment.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal treatment | Other | Both groups of patients (smokers and non-smokers) will receive periodontal treatment consisting of scaling and planning root, 4 times in the first month and after that once a month until complete one year. Patients will be clinically evaluated and microbiological collects will be made at baseline, 3 months, 6 months and 1 year after periodontal treatment. Receives: Procedure: Periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of periodontal status represented by means/standard deviations of the percentage of high scores of PI and BOP and levels (mm) of PPD, GR and CAL in smokers and non-smokers patients before and after periodontal treatment
An experienced periodontist will perform clinical periodontal analysis and periodontal treatment. Six sites (mesio-buccal, mediobuccal, disto-buccal, mesio-lingual, medio-lingual, disto-lingual) of each selected tooth (at least six teeth) will be measured using standard scores for the following periodontal markers: Plaque Index (PI) and Bleeding On Probe (BOP) and determined the levels (mm) of Pocket Probing Depth (PPD), Gingival Recession (GR) and Clinical Attachment Level (CAL) using a periodontal probe PCP15 (PCP-UNC15, Hu-Friedy, Chicago, IL). Means/standard deviations will be calculated from the percentage of high scores of PI and BOP and levels (mm) of PPD, GR and CAL for each patient and after that for each group: smokers and non-smokers. All patients with periodontal disease (high scores of periodontal markers) will be submitted to periodontal treatment and clinically evaluated at baseline, 3 months, 6 months and 1 year after treatment.
Measured: Up to one year
Prevalence of periodontopathogens calculated in percentage of sites containing the species tested for PCR, comparing smokers and non-smokers
Gingival crevicular samples will be taken from 4 sites with the deepest PPD (>5mm) in each patient. DNA from these samples will be extracted using phenol-chloroform method and quantified in a spectrophotometer at 260 nm and stored at -20 °C. Microbial molecular identification will be carried out by PCR with specific primers for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Campylobacter rectus, Candida albicans, Candida glabrata, Candida tropicalis and Candida dublinienses. PCR amplification will be performed with a GeneAmp PCR system 2400 (Perkin-Elmer - Applied Biosystems) for TGradient 96 (Biometra, Germany) under thermal conditions specific for each pair of primers. The prevalence of periodontopathogens will be calculated in percentage of sites containing the species tested for PCR, comparing smokers and non-smokers at baseline, 3 months, 6 months and 1 year after periodontal treatment.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Cristiane Duque, University of Sao Paulo
- Investigators
- Cristiane Duque, PhD, Principal investigator, University of Sao PauloGabriela AC Camargo, PhD, Study director, Federal Fluminense University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581319
- Sponsor's protocol ID
- E-26/103.243/2012
- Status last verified
- Oct 2015
- First submitted
- 13 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Conditions and Prevalence of Periodontopathogens in Smokers and Non-smokers After Periodontal Therapy
- ClinicalTrials.gov ID
- NCT02581319
- Acronym / sponsor ID
- E-26/103.243/2012
- Conditions
- Periodontal Disease, Smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 20 Oct 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.
Smoking has been considered the most important risk factor for periodontitis among all lifestyle factors. Fewer studies evaluated longitudinal clinical and microbiological status of smokers undergoing periodontal maintenance therapy and controversial results were found. This study will evaluate clinical conditions and prevalence of putative periodontopathogens and Candida spp. in smokers and non-smokers at baseline and after 3 and 6 months of nonsurgical periodontal therapy. Clinical parameters, including oral status assessed using Plaque Index (PI), Bleeding On Probe (BOP), Pocket Probing Depth (PPD), Gingival Recession (GR), Clinical Attachment Level (CAL) will be measured in smokers and non-smokers patients with chronic periodontitis. Samples of subgingival biofilm will be obtained from the periodontal pockets and furcation sites and submitted to phenol-chloroform DNA extraction and Polymerase Chain Reaction (PCR) analysis using specific primers for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Campylobacter rectus, Candida albicans, Candida glabrata, Candida tropicalis and Candida dublinienses.
Detailed description
Sixty patients (30 smokers (SM) and 30 non-smokers (NS) will be selected to participate of this study. All subjects will be recruited from the Department of Periodontology, School of Dentistry, Fluminense Federal University, Nova Friburgo, Rio de Janeiro State, Brazil. The study protocol was approved (protocol number: CAAE - 0070.0.258.000-10) by the Ethics Committee of the School of Medicine, Fluminense Federal University. Prior to participation, the purpose and procedures will be fully explained to all patients, who consequently gave written informed consent in accordance with the Helsinki Declaration. Medical and dental histories will be taken and patients will receive clinical evaluation at prescreening visits.
Clinical examination, microbiological collects and periodontal therapy Previous clinical examination, information about years of consumption of cigars and quantity of daily consumption will be recorded to select smokers and non- smokers subjects for the study. An experienced periodontist will perform clinical periodontal parameters in teeth for the protocol procedure. Each selected tooth selected will be measured for: Plaque Index (PI), Bleeding On Probe (BOP), Pocket Probing Depth (PPD), Gingival Recession (GR), Clinical Attachment Level (CAL) using a periodontal probe PCP15 (PCP-UNC15, Hu-Friedy, Chicago, IL), six sites (mesio-buccal, mediobuccal, disto-buccal, mesio-lingual, medio-lingual, disto-lingual) will be recorded. Sites with probing depth (PPD) > 5mm will be selected for microbiological analysis. After clinical measurements, the supragingival biofilm will be removed with sterile gauze. Gingival crevicular samples will be taken from 4 sites with the deepest PPD (>5mm) in each patient using a sterile paper point from the deepest pocket for 30s. Pooled biofilms from each site will be separated in two microtubes containing Tris -EDTA buffer (10 mM Tris-Hcl, 0.1 mM EDTA, pH 7.5) and were stored at -20°C. The samples will be analyzed microbiologically by Polymerase Chain Reaction - PCR. Periodontal treatment will be consisted of scaling and planning root, 4 times in first month and after that once a month until complete 1 year. Patients will be clinically evaluated and microbiological collects will be made at baseline, 3 months, 6 months and 1 year after periodontal treatment.
Microbiological evaluation - PCR assays DNA will be extracted and quantified in a spectrophotometer at 260 nm (Genesys 10UV, Rochester, NY, USA), in order to obtain a standard concentration of 100 ng/mL and stored at -20 °C for subsequent PCR reactions. Briefly, samples will be submitted to a lise solution (extraction buffer and proteinase K) and then purified using chloroform:isoamil-alcohol, followed by DNA precipitation with isopropanol and 70% ethanol. The DNA will be resuspended in TE buffer (10 mM Tris-HCl, 0.1 mM EDTA, pH 7.5, with 10 μg/mL RNAse). Microbial molecular identification will be carried out by PCR with specific primers for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Campylobacter rectus, Candida albicans, Candida glabrata, Candida tropicalis and Candida dublinienses. PCR amplification will be performed with a GeneAmp PCR system 2400 (Perkin-Elmer - Applied Biosystems) for TGradient 96 (Biometra, Germany) under thermal conditions specific for each pair of primers. The PCR products will be separated by electrophoresis in 2% agarose gels and Tris-borate-EDTA running buffer (pH 8.0). The molecular mass ladder (100 bp DNA ladder, Gibco, Grand Island, NY, USA) will be included for running in the agarose gel. The DNA will be stained with 0.1µl of Sybr Safe/mL (Invitrogen, CA, USA) and visualized under UV illumination (Pharmacia LKB-MacroVue, San Gabriel, CA, USA). Photographs of the images will be taken (Image Mater - LISCAP, VDS, Pharmacia Biotech Piscataway, NJ, USA) and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periodontal treatment | Other | Procedure: Periodontal treatmentBoth groups of patients (smokers and non-smokers) will receive periodontal treatment consisting of scaling and planning root, 4 times in the first month and after that once a month until complete one year. Patients will be clinically evaluated and microbiological collects will be made at baseline, 3 months, 6 months and 1 year after periodontal treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presence of periodontal disease in unirradicular teeth
- bleeding on probing in sites where probing depth was ≥5 mm in a minimum of two teeth in different arch;
- radiographic bone loss ranging from 30% to 50%.
Key exclusion criteria (4 listed)
- patients with systemic diseases, diabetes; osteoporosis;
- pregnant lactating females;
- use of immune suppressive medication, phenytoin, cyclosporine, calcium channel blockers or any use of antibiotics or nonsteroidal anti-inflammatory drugs in the past 3 months;
- any medical conditions requiring immunotherapy or diagnosed as HIV+ or with AIDS, that could interfere with the periodontium status.
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 |
|---|---|---|
| Periodontal treatmentAlso: Scaling and planning rootPeriodontal treatment will consist of scaling and planning root, 4 times in the first month and after that once a month until complete one year. Patients will be clinically evaluated and microbiological collects were made at baseline, 3 months, 6 months and 1 year after periodontal treatment. | Procedure or surgery | Periodontal treatment |
Primary outcome
Evaluation of periodontal status represented by means/standard deviations of the percentage of high scores of PI and BOP and levels (mm) of PPD, GR and CAL in smokers and non-smokers patients before and after periodontal treatment
Time frame: Up to one year
An experienced periodontist will perform clinical periodontal analysis and periodontal treatment. Six sites (mesio-buccal, mediobuccal, disto-buccal, mesio-lingual, medio-lingual, disto-lingual) of each selected tooth (at least six teeth) will be measured using standard scores for the following periodontal markers: Plaque Index (PI) and Bleeding On Probe (BOP) and determined the levels (mm) of Pocket Probing Depth (PPD), Gingival Recession (GR) and Clinical Attachment Level (CAL) using a periodontal probe PCP15 (PCP-UNC15, Hu-Friedy, Chicago, IL). Means/standard deviations will be calculated from the percentage of high scores of PI and BOP and levels (mm) of PPD, GR and CAL for each patient and after that for each group: smokers and non-smokers. All patients with periodontal disease (high scores of periodontal markers) will be submitted to periodontal treatment and clinically evaluated at baseline, 3 months, 6 months and 1 year after treatment.
Prevalence of periodontopathogens calculated in percentage of sites containing the species tested for PCR, comparing smokers and non-smokers
Time frame: Up to one year
Gingival crevicular samples will be taken from 4 sites with the deepest PPD (>5mm) in each patient. DNA from these samples will be extracted using phenol-chloroform method and quantified in a spectrophotometer at 260 nm and stored at -20 °C. Microbial molecular identification will be carried out by PCR with specific primers for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Campylobacter rectus, Candida albicans, Candida glabrata, Candida tropicalis and Candida dublinienses. PCR amplification will be performed with a GeneAmp PCR system 2400 (Perkin-Elmer - Applied Biosystems) for TGradient 96 (Biometra, Germany) under thermal conditions specific for each pair of primers. The prevalence of periodontopathogens will be calculated in percentage of sites containing the species tested for PCR, comparing smokers and non-smokers at baseline, 3 months, 6 months and 1 year after periodontal treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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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.
Cristiane Duque, PhD principal investigator
University of Sao Paulo
Gabriela AC Camargo, PhD study director
Federal Fluminense University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal treatment in people with Periodontal Disease and Smoking, run by University of Sao Paulo at 1 site in Brazil.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriela AC Camargo, PhD (:+55 22 2528-7168, gaby.3003@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of periodontal status represented by means/standard deviations of the percentage of high scores of PI and BOP and levels (mm) of PPD, GR and CAL in smokers and non-smokers patients before and after periodontal treatment (time frame: Up to one year). The study lists 2 primary outcomes in all. 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 21 Oct 2015.