Diabetes Mellitus Type 2Early Phase 1NCT01475435
Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients
A Early Phase 1 study testing non- surgical periodontal treatment and Prophylaxis in people with Diabetes Mellitus Type 2, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Abstract Diabetes mellitus and periodontal diseases are both chronic inflammatory disorders that have a major impact on the health and well being of millions of individuals worldwide. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- non- surgical periodontal treatment and Prophylaxis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Aug 2013
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes and chronic periodontitis(more than 30% of the sites involved, AAP, 1999)
- Patients with type 2 diabetes and periodontally healthy (AAP, 1999)
- Patients systemically healthy with chronic periodontitis (more than 30% of the sites involved)
- Patients systemically and periodontally healthy
- Patients with at least 15 natural teeth (excluding 3rd molars).
- At least 30% of sites with probing pocket depth (PD)> 5 mm and a maximum of 60% sites with PS <7 mm
Show all 9Show fewer
- Clinical attachment level (CAL)> 4 mm
- Visible plaque and bleeding on probing (BOP)
- Patients with type 2 diabetes have to bear the disease for at least five years and have to show a blood percentage of glycated hemoglobin between 6.5% to 8% (UKPDS 1998) at baseline
Who cannot join
- Individuals with periodontal pockets deeper than 7 mm
- Patients with any other systemic disease (except diabetes type 2)
- Patients who have used medications such as anticoagulants, contraceptives or antidepressants in the past 6 months
- Patients who have used antibiotic and anti-inflammatory drugs in the last 3 months before the of the study
- Smoking
- Pregnancy
- Patients who have received periodontal treatment in the last six months before the start of this study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo
São Paulo, São Paulo, 05508-000
Luiz Antônio Pugliesi Alves de Lima, PhD, 55-11-30917833, lapalima@usp.br
Ana Paula Sassá Benedete, 55-11-30917833, abenedete@gmail.com
About this study
Official title: Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients With Generalized Chronic Periodontitis and Healthy Periodontium
Abstract Diabetes mellitus and periodontal diseases are both chronic inflammatory disorders that have a major impact on the health and well being of millions of individuals worldwide. Periodontal diseases are among the most common diseases in humans, therefore, if the presence of periodontal diseases plays any role in overall systemic health, the public health impact may be substantial. An important factor that can be involved in the progression of the periodontal disease is the production of Reactive Oxygen Species (ROS). The imbalance between oxidative stress induced by ROS and the concentrations (or activity) of the antioxidant may result in tissue damage. The ROS induce the activity of lipid peroxidation-Tbars, myeloperoxidase (MPO), peroxidase and arginase, whose mechanisms reflect the severity of the periodontal disease and it may offer the basis for a patient specific diagnostic test for periodontitis and could have therapeutic significance. The aim of this study is to investigate quantitatively the levels of oxidative stress markers (Myeloperoxidase, Peroxidase, Lipid Peroxidation and Arginase) in saliva and in gingival crevicular fluid (GCF) of diabetes type 2 subjects with generalized chronic periodontitis and periodontally healthy individuals, and systematically healthy individuals with generalized chronic periodontitis and periodontally healthy individuals, before and after periodontal treatment. Unstimulated whole saliva will be collected for 5 min as well as GCF of 25 diabetes type 2 with generalized chronic periodontitis, 25 diabetes type 2 periodontally healthy individuals as controls, 25 systematically healthy individuals with generalized chronic periodontitis and 25 periodontally healthy individuals before and after treatment. The following clinical parameters will be evaluated: probing pocket depth, probing attachment level, plaque index and the gingival index. The activity of stress markers in saliva and GFC will be analyzed by spectrophotometry. Adequate statistical analysis will be carried out with a p-value set at p < 0.05.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- non- surgical periodontal treatment, Prophylaxis
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non- surgical periodontal treatmentProcedure or surgery
scaling and root planning
ProphylaxisProcedure or surgery
Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| chronic periodontitis | Active comparator | Saliva and GCF samples will be evaluated before and after treatment from patients treated of chronic periodontitis. Receives: Procedure: non- surgical periodontal treatment |
| periodontally healthy individuals | Placebo comparator | Saliva and GCF samples will be evaluated from periodontally healthy individuals at baseline. Receives: Procedure: Prophylaxis |
| chronic periodontitis with diabetes type 2 | Active comparator | Saliva and GCF samples will be evaluated before and after treatment from patients with diabetes type 2 treated of chronic periodontitis Receives: Procedure: non- surgical periodontal treatment |
| periodontally healthy individuals with diabetes type 2 | Placebo comparator | Saliva and GCF samples will be evaluated from periodontally healthy individuals with diabetes type 2 at baseline Receives: Procedure: Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate level change of oxidative stress biomarkers in crevicular gingival fluid and whole saliva on diabetes type 2 individuals
The participants will be followed for an expected average of 4 weeks after periodontal treatment. The samples of saliva and crevicular gingival fluid will be evaluated at baseline and four weeks after periodontal treatment.
Measured: baseline and 4 weeks 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 posted21 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Principal investigator, Luiz Antonio Pugliesi Alves de Lima, University of Sao Paulo
- Investigators
- Luiz A Lima, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475435
- Sponsor's protocol ID
- DMSAL2712
- Status last verified
- Aug 2011
- First submitted
- 22 Aug 2011
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients With Generalized Chronic Periodontitis and Healthy Periodontium
- ClinicalTrials.gov ID
- NCT01475435
- Acronym / sponsor ID
- DMSAL2712
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 21 Nov 2011 (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.
Abstract Diabetes mellitus and periodontal diseases are both chronic inflammatory disorders that have a major impact on the health and well being of millions of individuals worldwide. Periodontal diseases are among the most common diseases in humans, therefore, if the presence of periodontal diseases plays any role in overall systemic health, the public health impact may be substantial. An important factor that can be involved in the progression of the periodontal disease is the production of Reactive Oxygen Species (ROS). The imbalance between oxidative stress induced by ROS and the concentrations (or activity) of the antioxidant may result in tissue damage. The ROS induce the activity of lipid peroxidation-Tbars, myeloperoxidase (MPO), peroxidase and arginase, whose mechanisms reflect the severity of the periodontal disease and it may offer the basis for a patient specific diagnostic test for periodontitis and could have therapeutic significance. The aim of this study is to investigate quantitatively the levels of oxidative stress markers (Myeloperoxidase, Peroxidase, Lipid Peroxidation and Arginase) in saliva and in gingival crevicular fluid (GCF) of diabetes type 2 subjects with generalized chronic periodontitis and periodontally healthy individuals, and systematically healthy individuals with generalized chronic periodontitis and periodontally healthy individuals, before and after periodontal treatment. Unstimulated whole saliva will be collected for 5 min as well as GCF of 25 diabetes type 2 with generalized chronic periodontitis, 25 diabetes type 2 periodontally healthy individuals as controls, 25 systematically healthy individuals with generalized chronic periodontitis and 25 periodontally healthy individuals before and after treatment. The following clinical parameters will be evaluated: probing pocket depth, probing attachment level, plaque index and the gingival index. The activity of stress markers in saliva and GFC will be analyzed by spectrophotometry. Adequate statistical analysis will be carried out with a p-value set at p < 0.05.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| chronic periodontitis | Active comparator | Procedure: non- surgical periodontal treatmentSaliva and GCF samples will be evaluated before and after treatment from patients treated of chronic periodontitis. |
| periodontally healthy individuals | Placebo comparator | Procedure: ProphylaxisSaliva and GCF samples will be evaluated from periodontally healthy individuals at baseline. |
| chronic periodontitis with diabetes type 2 | Active comparator | Procedure: non- surgical periodontal treatmentSaliva and GCF samples will be evaluated before and after treatment from patients with diabetes type 2 treated of chronic periodontitis |
| periodontally healthy individuals with diabetes type 2 | Placebo comparator | Procedure: ProphylaxisSaliva and GCF samples will be evaluated from periodontally healthy individuals with diabetes type 2 at baseline |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with type 2 diabetes and chronic periodontitis(more than 30% of the sites involved, AAP, 1999)
- Patients with type 2 diabetes and periodontally healthy (AAP, 1999)
- Patients systemically healthy with chronic periodontitis (more than 30% of the sites involved)
- Patients systemically and periodontally healthy
- Patients with at least 15 natural teeth (excluding 3rd molars).
Key exclusion criteria (7 listed)
- Individuals with periodontal pockets deeper than 7 mm
- Patients with any other systemic disease (except diabetes type 2)
- Patients who have used medications such as anticoagulants, contraceptives or antidepressants in the past 6 months
- Patients who have used antibiotic and anti-inflammatory drugs in the last 3 months before the of the study
- Smoking
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 treatmentscaling and root planning | Procedure or surgery | chronic periodontitis, chronic periodontitis with diabetes type 2 |
| ProphylaxisPeriodontally healthy patients will receive oral hygiene instructions and prophylaxis. | Procedure or surgery | periodontally healthy individuals, periodontally healthy individuals with diabetes type 2 |
Primary outcome
Evaluate level change of oxidative stress biomarkers in crevicular gingival fluid and whole saliva on diabetes type 2 individuals
Time frame: baseline and 4 weeks after periodontal treatment
The participants will be followed for an expected average of 4 weeks after periodontal treatment. The samples of saliva and crevicular gingival fluid will be evaluated at baseline and four weeks 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 Nov 2011.
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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.
Luiz A Lima, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing non- surgical periodontal treatment and Prophylaxis in people with Diabetes Mellitus Type 2, 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 9 inclusion and 7 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 Nov 2011. 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. Some participants in this study may receive a placebo. 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?
Contact Luiz Antônio Pugliesi Alves de Lima, PhD (55-11-30917833, lapalima@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate level change of oxidative stress biomarkers in crevicular gingival fluid and whole saliva on diabetes type 2 individuals (time frame: baseline and 4 weeks 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 21 Nov 2011.