Metabolic SyndromeNCT02012842
Metabolic Syndrome and Periodontitis
A study testing Non surgical periodontal treatment in people with Metabolic Syndrome and Periodontal Disease, run by Federal University of Rio Grande do Sul at 2 sites in Brazil.
Trial summary
The aim of this study is to evaluate the effect of periodontal treatment on systemic inflammation and quality of life of individuals with metabolic syndrome. There will be a randomized clinical trial with patients from the clinic of Endocrinology - Prediabetes (Hospital de Clinicas de Porto Alegre) and outpatient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Periodontal Disease, Inflammatory Response
- What is being tested?
- Non surgical periodontal treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 2 sitesBrazil
- Study dates
- May 2014to Dec 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than or equal to 18
- at least 10 teeth
- diagnosis of periodontitis ( > 2 interproximal sites with PD> 5 mm in distinct teeth or > 2 interproximal sites with PI > 4mm in different teeth of according to Page and Eke , 2007)
- have metabolic syndrome (The patient must present at least among the following three criteria: (a ) waist circumference greater than 90 inches for men and for women over 80 , (b) triglycerides ≥ 150 mg / dl ( 1.7 mmol / L ) or as a treatment for hypertriglyceridemia (c ) HDL cholesterol less than 40 mg / dL for men and less than 50 mg / dl for women or being treated for dyslipidemia ; ( d ) hypertension at examination ( systolic ≥ 130 mm Hg and diastolic blood pressure ≥ 85 mm Hg ) or hypertension diagnosis or past history or treatment for hypertension , (e ) plasma glucose ≥ 100 mg / dl or a diagnosis of diabetes or use of medication for glycemic control)
Who cannot join
- have periodontal treatment performed in the last six months
- have used antibiotics in the last 3 months
- have indication of antibiotic prophylaxis for dental care
- be pregnant
- chronic use of systemic corticosteroids
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Faculty of Dentistry, Federal University of Rio Grande do Sul and Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
Faculdade de Odontologia da UFRGS
Porto Alegre, Rio Grande do Sul, 90035003
About this study
Official title: The Effect of Periodontal Treatment on Quality of Life in Patients With Metabolic Syndrome
The aim of this study is to evaluate the effect of periodontal treatment on systemic inflammation and quality of life of individuals with metabolic syndrome. There will be a randomized clinical trial with patients from the clinic of Endocrinology - Prediabetes (Hospital de Clinicas de Porto Alegre) and outpatient dental clinic of the Faculty of Dentistry, Federal University of Rio Grande do Sul (UFRGS), who have a diagnosis of metabolic syndrome and diagnosis of periodontitis. The clinical trial will consist of an arm where it will be immediately periodontal treatment (test group) and another arm which will be held later periodontal treatment (control group). The study will last six months , and after this period, the control group will receive the same treatment to the test group . A socio-demographic questionnaire will be applied by a trained interviewer , so that data on income, education , behavioral habits , medical and dental history . Complete periodontal examination will be conducted at 6 sites per tooth for all teeth present at baseline and 3 and 6 months after periodontal treatment . In addition to the tests required for the diagnosis of metabolic syndrome , will be asked the same blood tests at 3 and 6 months after periodontal treatment (total cholesterol , LDL and HDL , fasting glucose , triglycerides , C-reactive protein). Aliquots of plasma from blood collected in each experimental point are stored at -80 ° C for analysis of interleukin- 6, Tumor Necrosis Factor- α (TNF-α) , Glucagon Like Peptide-1 (GLP-1) and adiponectin. At each clinical examination will be collected gingival crevicular fluid , supra and subgingival biofilm . Versions of the questionnaires validated in Brazil (OHIP-14)and WHOQoL Bref will be applied to assess quality of life at baseline and after 6 months of the study . The primary outcome will be change in glycated hemoglobin and secondary outcomes will be changes in serum fibrinogen and C-reactive protein.The hypothesis of this study considers that periodontal treatment can alter the serum levels of C-reactive protein, fibrinogen and glycosylated hemoglobin in patients with metabolic syndrome and thereby contribute to improved quality of life. The objective of this study is to evaluate the effect of periodontal treatment on systemic inflammation and quality of life of individuals with metabolic syndrome.
Read the detailed description
There will be a randomized clinical trial with patients from the outpatient clinic of Endocrinology - Prediabetes and outpatient dental clinic of the Faculty of Dentistry, UFRGS who have a diagnosis of metabolic syndrome and diagnosis of periodontitis. The clinical trial will consist of an arm where it will be immediately periodontal treatment (test group) and another arm which will be held later periodontal treatment (control group). The study will last for six months , and after this period, the control group will receive the same treatment to the test group .
A socio-demographic questionnaire will be applied by a trained interviewer , so that data on income, education , behavioral habits , medical and dental history. A questionnaire with some key questions will be repeated in 10 % of the sample within seven days after the first application in order to check the reproducibility of the instrument.
Complete periodontal examination will be conducted at 6 sites per tooth for all teeth present at baseline and 3 and 6 months after periodontal treatment. The examination will be conducted by two examiners trained and calibrated. There will be measured Probing Depth , Bleeding On Probing, Periodontal Attachment Loss , Gingival Bleeding Index , Visible Plaque Index and the retentive factors of plaque.
In addition to the tests required for the diagnosis of metabolic syndrome , will be did the same blood tests at 3 and 6 months after periodontal treatment (total cholesterol , LDL and HDL , fasting glucose , triglycerides , C-reactive protein) . Aliquots of plasma from blood collected in each experimental point are stored at -80 ° C for analysis of interleukin- 6, TNF- α , GLP-1 and adiponectin .
At each clinical examination will be collected gingival crevicular fluid , and subgingival biofilm above 4 sites randomized among those with higher probing depth at baseline. The sites of fluid collection will be properly insulated with cotton rolls and / or gauze and dried with air jets . From the introduction of rectangles of absorbent paper (Periopaper ) for 30 seconds will be held in the gingival sulcus fluid collection . Periopaper strips are analyzed for volume (Periotron 8000) and stored in sterile plastic tube at -80 ° C until analysis. The presence of Il- 1β , IL-6 and TNF- α in the gingival fluid will be identified by flow cytometry .
The supragingival plaque will be collected with sterile spoon dentin and subgingival plaque will be collected with a sterile paper cone inserted in selected sites for 30 seconds , after drying the surface and careful removal of supragingival plaque . The cones are stored in sterile plastic tube at -80 ° C until analysis. The identification of total bacterial load and microbial periodontal ( Porphyromonas gingivalis , Fusobacterium nucleatum , Prevotella intermedia and Streptpcoccus mitis ) will be performed using the technique of real -time PCR and T - RFLP .
Dental treatment will be performed by two periodontists who either ignore the data for examination of patients . The test group will receive nonsurgical periodontal treatment in 4 weeks. The treatment will include caries removal and sealing of cavities or caries restoration , removal of restorations maladaptive , extraction of residual roots , removal of supragingival calculus and subgingival scaling and root planing under local anesthesia . Instruction, training and motivation for oral hygiene will be addressed throughout treatment. Completed treatment , patients return to fortnightly visits to the 3 month and monthly until month 6 , where it will be professional removal of supra and subgingival biofilm , and oral hygiene instruction . In 3 and 6 months will also be repeated full mouth examination for both test and control groups .
The control group will receive information about periodontal disease, as well as an oral hygiene kit consisting of multicerdas toothbrush , toothpaste and interdental brush . The same treatment given to the test group will be held in the control group immediately after the 6-month assessment . The period of six months waiting for dental treatment for individuals in the control group is supported in the literature
- Being tested
- Non surgical periodontal treatment
- Keywords
- Metabolic Syndrome, Periodontal Disease, Periodontal therapy, inflammatory markers, C reactive protein, serum fibrinogen, glycated hemoglobin
- Medical subject headings
- Metabolic Syndrome, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical periodontal treatmentOther
Also called strict supragingival plaque control, non surgical periodontal therapy, scaling and root planning
Treatment of gingivitis: excavation and sealing of cavities, removal of overhanging restorations, extraction of hopeless teeth, supragingival calculus removal. Oral hygiene instruction, training and motivation will be given at each appointment. Treatment of periodontitis: subgingival scaling and root planing under local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Immediate periodontal treatment | Active comparator | Strict supragingival plaque control and non surgical periodontal treatment immediately after the baseline examination(test group). Receives: Other: Non surgical periodontal treatment |
| Delayed periodontal treatment | Other | Strict plaque control and non surgical periodontal treatment 6 months after the baseline examination (control group). Receives: Other: Non surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes at glycated hemoglobin.
Glycated hemoglobin will be measured by collecting blood tests at 0, 3 and 6 months after the periodontal treatment (test and control)
Measured: This measure will be measured in 0 (baseline), 3 and 6 months after periodontal treatment.
Secondary outcomes (1)
Changes at Protein C reactive and serum fibrinogen.
Protein C reactive and serum fibrinogen will be measured by collecting blood tests at 0, 3 and 6 months after the periodontal treatment (test and control).
Measured: These outcomes will be measured at 0, 3 and 6 months after periodontal treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startMay 2014
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Patricia Weidlich, Federal University of Rio Grande do Sul
- Investigators
- Rui V Oppermann, PhD, Principal investigator, Federal University of Rio Grande do SulFernando Gerchman, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012842
- Sponsor's protocol ID
- 060173
- Status last verified
- May 2017
- First submitted
- 30 Oct 2013
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Periodontal Treatment on Quality of Life in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02012842
- Acronym / sponsor ID
- 060173
- Keywords
- Metabolic Syndrome, Periodontal Disease, Periodontal therapy, inflammatory markers, C reactive protein, serum fibrinogen, glycated hemoglobin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- May 2014
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Dec 2013 (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 study is to evaluate the effect of periodontal treatment on systemic inflammation and quality of life of individuals with metabolic syndrome. There will be a randomized clinical trial with patients from the clinic of Endocrinology - Prediabetes (Hospital de Clinicas de Porto Alegre) and outpatient dental clinic of the Faculty of Dentistry, Federal University of Rio Grande do Sul (UFRGS), who have a diagnosis of metabolic syndrome and diagnosis of periodontitis. The clinical trial will consist of an arm where it will be immediately periodontal treatment (test group) and another arm which will be held later periodontal treatment (control group). The study will last six months , and after this period, the control group will receive the same treatment to the test group . A socio-demographic questionnaire will be applied by a trained interviewer , so that data on income, education , behavioral habits , medical and dental history . Complete periodontal examination will be conducted at 6 sites per tooth for all teeth present at baseline and 3 and 6 months after periodontal treatment . In addition to the tests required for the diagnosis of metabolic syndrome , will be asked the same blood tests at 3 and 6 months after periodontal treatment (total cholesterol , LDL and HDL , fasting glucose , triglycerides , C-reactive protein). Aliquots of plasma from blood collected in each experimental point are stored at -80 ° C for analysis of interleukin- 6, Tumor Necrosis Factor- α (TNF-α) , Glucagon Like Peptide-1 (GLP-1) and adiponectin. At each clinical examination will be collected gingival crevicular fluid , supra and subgingival biofilm . Versions of the questionnaires validated in Brazil (OHIP-14)and WHOQoL Bref will be applied to assess quality of life at baseline and after 6 months of the study . The primary outcome will be change in glycated hemoglobin and secondary outcomes will be changes in serum fibrinogen and C-reactive protein.The hypothesis of this study considers that periodontal treatment can alter the serum levels of C-reactive protein, fibrinogen and glycosylated hemoglobin in patients with metabolic syndrome and thereby contribute to improved quality of life. The objective of this study is to evaluate the effect of periodontal treatment on systemic inflammation and quality of life of individuals with metabolic syndrome.
Detailed description
There will be a randomized clinical trial with patients from the outpatient clinic of Endocrinology - Prediabetes and outpatient dental clinic of the Faculty of Dentistry, UFRGS who have a diagnosis of metabolic syndrome and diagnosis of periodontitis. The clinical trial will consist of an arm where it will be immediately periodontal treatment (test group) and another arm which will be held later periodontal treatment (control group). The study will last for six months , and after this period, the control group will receive the same treatment to the test group .
A socio-demographic questionnaire will be applied by a trained interviewer , so that data on income, education , behavioral habits , medical and dental history. A questionnaire with some key questions will be repeated in 10 % of the sample within seven days after the first application in order to check the reproducibility of the instrument.
Complete periodontal examination will be conducted at 6 sites per tooth for all teeth present at baseline and 3 and 6 months after periodontal treatment. The examination will be conducted by two examiners trained and calibrated. There will be measured Probing Depth , Bleeding On Probing, Periodontal Attachment Loss , Gingival Bleeding Index , Visible Plaque Index and the retentive factors of plaque.
In addition to the tests required for the diagnosis of metabolic syndrome , will be did the same blood tests at 3 and 6 months after periodontal treatment (total cholesterol , LDL and HDL , fasting glucose , triglycerides , C-reactive protein) . Aliquots of plasma from blood collected in each experimental point are stored at -80 ° C for analysis of interleukin- 6, TNF- α , GLP-1 and adiponectin .
At each clinical examination will be collected gingival crevicular fluid , and subgingival biofilm above 4 sites randomized among those with higher probing depth at baseline. The sites of fluid collection will be properly insulated with cotton rolls and / or gauze and dried with air jets . From the introduction of rectangles of absorbent paper (Periopaper ) for 30 seconds will be held in the gingival sulcus fluid collection . Periopaper strips are analyzed for volume (Periotron 8000) and stored in sterile plastic tube at -80 ° C until analysis. The presence of Il- 1β , IL-6 and TNF- α in the gingival fluid will be identified by flow cytometry .
The supragingival plaque will be collected with sterile spoon dentin and subgingival plaque will be collected with a sterile paper cone inserted in selected sites for 30 seconds , after drying the surface and careful removal of supragingival plaque . The cones are stored in sterile plastic tube at -80 ° C until analysis. The identification of total bacterial load and microbial periodontal ( Porphyromonas gingivalis , Fusobacterium nucleatum , Prevotella intermedia and Streptpcoccus mitis ) will be performed using the technique of real -time PCR and T - RFLP .
Dental treatment will be performed by two periodontists who either ignore the data for examination of patients . The test group will receive nonsurgical periodontal treatment in 4 weeks. The treatment will include caries removal and sealing of cavities or caries restoration , removal of restorations maladaptive , extraction of residual roots , removal of supragingival calculus and subgingival scaling and root planing under local anesthesia . Instruction, training and motivation for oral hygiene will be addressed throughout treatment. Completed treatment , patients return to fortnightly visits to the 3 month and monthly until month 6 , where it will be professional removal of supra and subgingival biofilm , and oral hygiene instruction . In 3 and 6 months will also be repeated full mouth examination for both test and control groups .
The control group will receive information about periodontal disease, as well as an oral hygiene kit consisting of multicerdas toothbrush , toothpaste and interdental brush . The same treatment given to the test group will be held in the control group immediately after the 6-month assessment . The period of six months waiting for dental treatment for individuals in the control group is supported in the literature
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate periodontal treatment | Active comparator | Other: Non surgical periodontal treatmentStrict supragingival plaque control and non surgical periodontal treatment immediately after the baseline examination(test group). |
| Delayed periodontal treatment | Other | Other: Non surgical periodontal treatmentStrict plaque control and non surgical periodontal treatment 6 months after the baseline examination (control group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- older than or equal to 18
- at least 10 teeth
- diagnosis of periodontitis ( > 2 interproximal sites with PD> 5 mm in distinct teeth or > 2 interproximal sites with PI > 4mm in different teeth of according to Page and Eke , 2007)
- have metabolic syndrome (The patient must present at least among the following three criteria: (a ) waist circumference greater than 90 inches for men and for women over 80 , (b) triglycerides ≥ 150 mg / dl ( 1.7 mmol / L ) or as a treatment for hypertriglyceridemia (c ) HDL cholesterol less than 40 mg / dL for men and less than 50 mg / dl for women or being treated for dyslipidemia ; ( d ) hypertension at examination ( systolic ≥ 130 mm Hg and diastolic blood pressure ≥ 85 mm Hg ) or hypertension diagnosis or past history or treatment for hypertension , (e ) plasma glucose ≥ 100 mg / dl or a diagnosis of diabetes or use of medication for glycemic control)
Key exclusion criteria (5 listed)
- have periodontal treatment performed in the last six months
- have used antibiotics in the last 3 months
- have indication of antibiotic prophylaxis for dental care
- be pregnant
- chronic use of systemic corticosteroids
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 |
|---|---|---|
| Non surgical periodontal treatmentAlso: strict supragingival plaque control, non surgical periodontal therapy, scaling and root planningTreatment of gingivitis: excavation and sealing of cavities, removal of overhanging restorations, extraction of hopeless teeth, supragingival calculus removal. Oral hygiene instruction, training and motivation will be given at each appointment. Treatment of periodontitis: subgingival scaling and root planing under local anesthesia. | Other | Delayed periodontal treatment, Immediate periodontal treatment |
Primary outcome
Changes at glycated hemoglobin.
Time frame: This measure will be measured in 0 (baseline), 3 and 6 months after periodontal treatment.
Glycated hemoglobin will be measured by collecting blood tests at 0, 3 and 6 months after the periodontal treatment (test and control)
1 secondary outcome
Changes at Protein C reactive and serum fibrinogen.
Time frame: These outcomes will be measured at 0, 3 and 6 months 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 31 May 2017.
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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.
Rui V Oppermann, PhD principal investigator
Federal University of Rio Grande do Sul
Fernando Gerchman, PhD principal investigator
Hospital de Clinicas de Porto Alegre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non surgical periodontal treatment in people with Metabolic Syndrome and Periodontal Disease, run by Federal University of Rio Grande do Sul at 2 sites 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 4 inclusion and 5 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Changes at glycated hemoglobin. (time frame: This measure will be measured in 0 (baseline), 3 and 6 months after periodontal treatment.). 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 31 May 2017.