Chronic PeriodontitisEarly Phase 1NCT02879903
Prevalence of Porphyromonas Gingivalis Fimbrial Subunit Genotype in Smokers and Nonsmokers After Periodontal Therapy
A Early Phase 1 study testing Periodontal treatment, Microbiological collect and Questionnaire in people with Chronic Periodontitis, run by Universidade Federal Fluminense.
Trial summary
The aims of the present study will be identify 5 types of fimbrial subunit genotype strains in smokers and nonsmokers with periodontitis, before and after periodontal therapy. Third two periodontitis patients will be selected to these study, 16 nonsmokers and 16 smokers. Read more about this study
- Who is it for?
- Ages 27 to 70 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Periodontal treatment, Microbiological collect and Questionnaire
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2016
- Phase
- Early Phase 1
- 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 27 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic periodontitis Consumption of 10 or more cigarettes/day.
Who cannot join
- Diabetes mellitus Osteoporosis Pregnant and lactating females Immune suppressive medication Phenytoin Cyclosporine Calcium channel blockers Immunotherapy or diagnosed as HIV+
About this study
The aims of the present study will be identify 5 types of fimbrial subunit genotype strains in smokers and nonsmokers with periodontitis, before and after periodontal therapy. Third two periodontitis patients will be selected to these study, 16 nonsmokers and 16 smokers. Clinical and microbiological parameters were evaluated at baseline and 3 months after periodontal treatment: Plaque Index, Bleeding On Probe, Probing Depth, Gingival Recession and Clinical Attachment Level. The prevalence of P. gingivalis and fimbrial subunit gene strains will be determined by Polymerase Chain Reaction.
Read the detailed description
Porphyromonas gingivalis is one of the most prevalent periodontopathogens present in red complex that is considered to be infectious agent causing several types of periodontal diseases. P. gingivalis has ability to invade gingival epithelial cells and can survive for extended periods of time. Fimbriae have been characterized to be key factors in adhesion, invasion, and colonization. Fimbriae are also responsible for invasion of membrane vesicles into host cells. Long fimbriae (FimA), also known as major fimbriae, are long, peritrichous, filamentous components. They have a role in initial attachment and organization of biofilms, as they act as adhesins that mediate invasion and colonization of host cells contributing to P. gingivalis virulence.
Fimbrillin (FimA; structural subunit protein of fimbriae) is classified into 5 variants (types I to V) based on their nucleotide sequences. P. gingivalis strains possessing type II fimA are correlated with P. gingivalis-positive patients, and its occurrence was significantly increased with the more severe forms of periodontitis. Previous studies evaluated the differences among the prevalence of fimA genotypes and periodontal health status in adults. P. gingivalis was detected in 36.8% of the healthy subjects and in 87.1% periodontitis patients. Among the P. gingivalis-positive healthy adults, the most prevalent fimA type was type I (76.1%), followed by type V (29.7%). In contrast, a majority of the periodontitis patients carried type II fimA organisms (66.1%), followed by type IV (28.9%). These findings indicate that there are both disease-associated and non-disease-associated strains of P. gingivalis, and that their infectious traits influencing periodontal health status could be differentiated based on the clonal variation of fimA genes.
Tobacco consumption is a risk factor for periodontal disease. Several studies have been reported that smoker habit is associated with greater clinical attachment loss, recession and tooth loss and reduced bone height and density. However, controversial report has been discussed about the differences between smokers and non-smokers periodontopathogens. P. gingivalis have been report 52.2% prevalence in non-smokers and 66.7% in smokers (pocket depth 3-5 mm) , and are associated with high levels in sites with periodontitis.
The mechanism that tobacco affects the periodontal tissue is related with nicotine that has been associated with various cellular changes that may contribute to the initiation and subsequent progression of periodontal disease. It is promote local effect like the reduction of the gingival blood flow, what can be due to long-term effects on the inflammatory lesions, higher incidence of gingival recession and others clinical parameters in smokers is correlated with cytotoxic and vasoactive substances present in tobacco, including nicotine, carbon monoxide and reactive oxidant substances and systemic effect is that smoking is responsible for 90% of cases of lung cancer, type deadliest cancer for men and women smokers, as well as being associated with various lung diseases. Furthermore, they promote oxidative stress and alterations in the immunoinflammatory responses, reducing functional activity of leucocytes, macrophages, lymphocytes and other immune cells, impaired wound healing and microbial recognition.
Nonsurgical therapy using scaling and root planning is the most usual periodontal therapy, well-recognized by the improvement in clinical and microbiological parameters. Fewer studies evaluated longitudinal clinical and microbiological status of smokers undergoing periodontal maintenance therapy and controversial results were found with absence of difference in disease progression in comparison with nonsmokers. P. gingivalis has been reduced after periodontal treatment. Previous report related reduction of 93 % to P.gingivalis for non-smokers and 88 % for smokers after periodontal treatment.
- Conditions
- Chronic Periodontitis
- Being tested
- Periodontal treatment, Microbiological collect, Questionnaire
- Keywords
- Porphyromonas gingivalis, Periodontal treatment, Smokers
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal treatmentProcedure or surgery
An experienced periodontist will be performed clinical periodontal parameters, including Plaque Index, Bleeding On Probe, Pocket Probing Depth, Gingival Recession, Clinical Attachment Level using a periodontal probe, at six sites per tooth at all teeth, excluding third molars.
Quadrant scaling and root planning will be weekly performed on each patient under local anesthesia using periodontal curettes and ultrasonic scalers. The maintenance therapy will be included professional plaque control and Scaling and root planing in recurrent periodontal pockets.
Microbiological collectProcedure or surgery
Biofilm will be collected with the paper point to analyse presence of Porphyromonas gingivalis fimbrial subunit gene type I, II, III, IV and V.
QuestionnaireProcedure or surgery
Age will be expressed in years Sex -female and male, will be expressed in percentage. Time of cigarette consumption - will be expressed in years
| Study group | Role | What they receive |
|---|---|---|
| biofilm tobacco effect | Experimental | Group smokers - patients will receive periodontal treatment and biofilm will be collected. Receives: Procedure: Periodontal treatment; Procedure: Microbiological collect; Procedure: Questionnaire |
| biofilm non smoker effect | Experimental | Group Non Smokers - patients will receive periodontal treatment and biofilm will be collected. Receives: Procedure: Periodontal treatment; Procedure: Microbiological collect; Procedure: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Bleeding on Probe to 3 months
Bleeding On Probe will be expressed in percentage per individual to evaluate presence of bleeding on probe.
Measured: 3 months
Change from Baseline Plaque Index to 3 months
Plaque Index will be expressed in percentage per individual to evaluate presence of plaque.
Measured: 3 months
Change from Baseline Pocket Probing Depth to 3 months
Pocket Probing Depth will be evaluated in millimeter. The measure will be performed at six sites per tooth using a periodontal probe.
Measured: 3 months
Change from Baseline Gingival Recession to 3months
Gingival Recession will be evaluated in millimeter. The measure will be performed at six sites per tooth, from cementoenamel junction to gingival margin, using a periodontal probe.
Measured: 3 months
Change from Baseline Clinical Attachment level to 3 months
Clinical Attachment Level will be evaluated in millimeter. The measure will be performed at six sites per tooth, from cementoenamel junction to the end of periodontal pocket, using a periodontal probe.
Measured: 3 months
Change from Baseline Biofilm to 3 months
Pooled biofilms from each site with Probe Depth >5mm will be collected and checked for the presence of fimbrial subunit genotype of Porphyromonas gingivalis I, II, III, IV and V by Polymerase Chain Reaction analysis. The results will be expressed by percentage of frequency of each type of fim A.
Measured: 3 months
Change from baseline Age to 3 months
Age will be expressed in years.
Measured: 3 months
Change from Baseline Cigarette consumption to 3 months
Time of cigarette consumption - will be expressed in years.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Alessandra da Cruz Galhardo Camargo, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879903
- Sponsor's protocol ID
- CAAE: 53022216.0.0000.5626
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The result will be communicated verbally for each participant.
Publications
Lin X, Wu J, Xie H. Porphyromonas gingivalis minor fimbriae are required for cell-cell interactions. Infect Immun. 2006 Oct;74(10):6011-5. doi: 10.1128/IAI.00797-06.
PubMed 16988281Zhao L, Wu YF, Meng S, Yang H, OuYang YL, Zhou XD. Prevalence of fimA genotypes of Porphyromonas gingivalis and periodontal health status in Chinese adults. J Periodontal Res. 2007 Dec;42(6):511-7. doi: 10.1111/j.1600-0765.2007.00975.x.
PubMed 17956463Amano A, Kuboniwa M, Nakagawa I, Akiyama S, Morisaki I, Hamada S. Prevalence of specific genotypes of Porphyromonas gingivalis fimA and periodontal health status. J Dent Res. 2000 Sep;79(9):1664-8. doi: 10.1177/00220345000790090501.
PubMed 11023261Zeller I, Hutcherson JA, Lamont RJ, Demuth DR, Gumus P, Nizam N, Buduneli N, Scott DA. Altered antigenic profiling and infectivity of Porphyromonas gingivalis in smokers and non-smokers with periodontitis. J Periodontol. 2014 Jun;85(6):837-44. doi: 10.1902/jop.2013.130336. Epub 2013 Oct 23.
PubMed 24147843
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Porphyromonas Gingivalis Fimbrial Subunit Genotype in Smokers and Nonsmokers After Periodontal Therapy
- ClinicalTrials.gov ID
- NCT02879903
- Acronym / sponsor ID
- CAAE: 53022216.0.0000.5626
- Conditions
- Chronic Periodontitis
- Keywords
- Porphyromonas gingivalis, Periodontal treatment, Smokers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Aug 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 aims of the present study will be identify 5 types of fimbrial subunit genotype strains in smokers and nonsmokers with periodontitis, before and after periodontal therapy. Third two periodontitis patients will be selected to these study, 16 nonsmokers and 16 smokers. Clinical and microbiological parameters were evaluated at baseline and 3 months after periodontal treatment: Plaque Index, Bleeding On Probe, Probing Depth, Gingival Recession and Clinical Attachment Level. The prevalence of P. gingivalis and fimbrial subunit gene strains will be determined by Polymerase Chain Reaction.
Detailed description
Porphyromonas gingivalis is one of the most prevalent periodontopathogens present in red complex that is considered to be infectious agent causing several types of periodontal diseases. P. gingivalis has ability to invade gingival epithelial cells and can survive for extended periods of time. Fimbriae have been characterized to be key factors in adhesion, invasion, and colonization. Fimbriae are also responsible for invasion of membrane vesicles into host cells. Long fimbriae (FimA), also known as major fimbriae, are long, peritrichous, filamentous components. They have a role in initial attachment and organization of biofilms, as they act as adhesins that mediate invasion and colonization of host cells contributing to P. gingivalis virulence.
Fimbrillin (FimA; structural subunit protein of fimbriae) is classified into 5 variants (types I to V) based on their nucleotide sequences. P. gingivalis strains possessing type II fimA are correlated with P. gingivalis-positive patients, and its occurrence was significantly increased with the more severe forms of periodontitis. Previous studies evaluated the differences among the prevalence of fimA genotypes and periodontal health status in adults. P. gingivalis was detected in 36.8% of the healthy subjects and in 87.1% periodontitis patients. Among the P. gingivalis-positive healthy adults, the most prevalent fimA type was type I (76.1%), followed by type V (29.7%). In contrast, a majority of the periodontitis patients carried type II fimA organisms (66.1%), followed by type IV (28.9%). These findings indicate that there are both disease-associated and non-disease-associated strains of P. gingivalis, and that their infectious traits influencing periodontal health status could be differentiated based on the clonal variation of fimA genes.
Tobacco consumption is a risk factor for periodontal disease. Several studies have been reported that smoker habit is associated with greater clinical attachment loss, recession and tooth loss and reduced bone height and density. However, controversial report has been discussed about the differences between smokers and non-smokers periodontopathogens. P. gingivalis have been report 52.2% prevalence in non-smokers and 66.7% in smokers (pocket depth 3-5 mm) , and are associated with high levels in sites with periodontitis.
The mechanism that tobacco affects the periodontal tissue is related with nicotine that has been associated with various cellular changes that may contribute to the initiation and subsequent progression of periodontal disease. It is promote local effect like the reduction of the gingival blood flow, what can be due to long-term effects on the inflammatory lesions, higher incidence of gingival recession and others clinical parameters in smokers is correlated with cytotoxic and vasoactive substances present in tobacco, including nicotine, carbon monoxide and reactive oxidant substances and systemic effect is that smoking is responsible for 90% of cases of lung cancer, type deadliest cancer for men and women smokers, as well as being associated with various lung diseases. Furthermore, they promote oxidative stress and alterations in the immunoinflammatory responses, reducing functional activity of leucocytes, macrophages, lymphocytes and other immune cells, impaired wound healing and microbial recognition.
Nonsurgical therapy using scaling and root planning is the most usual periodontal therapy, well-recognized by the improvement in clinical and microbiological parameters. Fewer studies evaluated longitudinal clinical and microbiological status of smokers undergoing periodontal maintenance therapy and controversial results were found with absence of difference in disease progression in comparison with nonsmokers. P. gingivalis has been reduced after periodontal treatment. Previous report related reduction of 93 % to P.gingivalis for non-smokers and 88 % for smokers after periodontal treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biofilm tobacco effect | Experimental | Procedure: Periodontal treatment, Procedure: Microbiological collect, Procedure: QuestionnaireGroup smokers - patients will receive periodontal treatment and biofilm will be collected. |
| biofilm non smoker effect | Experimental | Procedure: Periodontal treatment, Procedure: Microbiological collect, Procedure: QuestionnaireGroup Non Smokers - patients will receive periodontal treatment and biofilm will be collected. |
Who may qualify
- Ages
- 27 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic periodontitis Consumption of 10 or more cigarettes/day.
Key exclusion criteria (1 listed)
- Diabetes mellitus Osteoporosis Pregnant and lactating females Immune suppressive medication Phenytoin Cyclosporine Calcium channel blockers Immunotherapy or diagnosed as HIV+
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 treatmentAn experienced periodontist will be performed clinical periodontal parameters, including Plaque Index, Bleeding On Probe, Pocket Probing Depth, Gingival Recession, Clinical Attachment Level using a periodontal probe, at six sites per tooth at all teeth, excluding third molars. Quadrant scaling and root planning will be weekly performed on each patient under local anesthesia using periodontal curettes and ultrasonic scalers. The maintenance therapy will be included professional plaque control and Scaling and root planing in recurrent periodontal pockets. | Procedure or surgery | biofilm non smoker effect, biofilm tobacco effect |
| Microbiological collectBiofilm will be collected with the paper point to analyse presence of Porphyromonas gingivalis fimbrial subunit gene type I, II, III, IV and V. | Procedure or surgery | biofilm non smoker effect, biofilm tobacco effect |
| QuestionnaireAge will be expressed in years Sex -female and male, will be expressed in percentage. Time of cigarette consumption - will be expressed in years | Procedure or surgery | biofilm non smoker effect, biofilm tobacco effect |
Primary outcome
Change from baseline Bleeding on Probe to 3 months
Time frame: 3 months
Bleeding On Probe will be expressed in percentage per individual to evaluate presence of bleeding on probe.
Change from Baseline Plaque Index to 3 months
Time frame: 3 months
Plaque Index will be expressed in percentage per individual to evaluate presence of plaque.
Change from Baseline Pocket Probing Depth to 3 months
Time frame: 3 months
Pocket Probing Depth will be evaluated in millimeter. The measure will be performed at six sites per tooth using a periodontal probe.
Change from Baseline Gingival Recession to 3months
Time frame: 3 months
Gingival Recession will be evaluated in millimeter. The measure will be performed at six sites per tooth, from cementoenamel junction to gingival margin, using a periodontal probe.
Change from Baseline Clinical Attachment level to 3 months
Time frame: 3 months
Clinical Attachment Level will be evaluated in millimeter. The measure will be performed at six sites per tooth, from cementoenamel junction to the end of periodontal pocket, using a periodontal probe.
Change from Baseline Biofilm to 3 months
Time frame: 3 months
Pooled biofilms from each site with Probe Depth >5mm will be collected and checked for the presence of fimbrial subunit genotype of Porphyromonas gingivalis I, II, III, IV and V by Polymerase Chain Reaction analysis. The results will be expressed by percentage of frequency of each type of fim A.
Change from baseline Age to 3 months
Time frame: 3 months
Age will be expressed in years.
Change from Baseline Cigarette consumption to 3 months
Time frame: 3 months
Time of cigarette consumption - will be expressed in years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Results publication: PubMed 16988281Lin X, Wu J, Xie H. Porphyromonas gingivalis minor fimbriae are required for cell-cell interactions. Infect Immun. 2006 Oct;74(10):6011-5. doi: 10.1128/IAI.00797-06.
- Results publication: PubMed 17956463Zhao L, Wu YF, Meng S, Yang H, OuYang YL, Zhou XD. Prevalence of fimA genotypes of Porphyromonas gingivalis and periodontal health status in Chinese adults. J Periodontal Res. 2007 Dec;42(6):511-7. doi: 10.1111/j.1600-0765.2007.00975.x.
- Results publication: PubMed 11023261Amano A, Kuboniwa M, Nakagawa I, Akiyama S, Morisaki I, Hamada S. Prevalence of specific genotypes of Porphyromonas gingivalis fimA and periodontal health status. J Dent Res. 2000 Sep;79(9):1664-8. doi: 10.1177/00220345000790090501.
- Results publication: PubMed 24147843Zeller I, Hutcherson JA, Lamont RJ, Demuth DR, Gumus P, Nizam N, Buduneli N, Scott DA. Altered antigenic profiling and infectivity of Porphyromonas gingivalis in smokers and non-smokers with periodontitis. J Periodontol. 2014 Jun;85(6):837-44. doi: 10.1902/jop.2013.130336. Epub 2013 Oct 23.
- Individual participant dataSharing planned: Yes. The result will be communicated verbally for each participant.
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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?
A Early Phase 1 study testing Periodontal treatment, Microbiological collect and Questionnaire in people with Chronic Periodontitis, run by Universidade Federal Fluminense.
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 1 inclusion and 1 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 30 Aug 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 from baseline Bleeding on Probe to 3 months (time frame: 3 months). The study lists 8 primary outcomes in all. 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 NCT02879903, which also lists 4 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 30 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.