Type 2 Diabetes Mellitus With Periodontal DiseaseNCT03198832
oxLDL in Diabetes Mellitus Patients and Disease Periodontal
A study testing Non-surgical periodontal treatment in people with Type 2 Diabetes Mellitus With Periodontal Disease, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus With Periodontal Disease
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2016to 28 Jan 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals older than 35 years with DM2 diagnosed for more than five years and HbA1c between 7% and 11%;
- be diagnosed with generalized chronic periodontitis: present at least 6 sites with periodontal pocket and loss of insertion above 5mm and two more bags with loss of insertion above 6mm;
- present at least 20 teeth;
- agree to participate in the study and sign the informed consent form
Who cannot join
- patients with cardiovascular diseases, cancer, gastrointestinal disorders, skin diseases, pregnancy, lactation, smoking, arthritis, lupus or other diseases of inflammatory origin;
- have undergone periodontal treatment in the last 12 months;
- have made use of antioxidant supplements, anti-inflammatories, or antibiotics within the previous 3 months;
- make use of medications that can alter the marking and concentration of oxLDL, for example, statins;
- have changed the medication for glycemic control in the last 3 months;
- present dental elements with pulpal or periapical inflammation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disease Periodontal Influence on Markers of Cardiovascular in Diabetes Mellitus Patients
Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters.
Read the detailed description
Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters. 44 patients will be divided into 2 groups: Diabetic Patients with Chronic Periodontitis (DM2DP) and Diabetic Patients without Chronic Periodontitis (DM2). The DM2DP group will receive periodontal debridement and DM2 group will be treated with supragingival scaling. Both groups receive board control every 3 months. At baseline, 3 and 6 months after treatment, will be held making the clinical periodontal parameters (plaque index, gingival index, probing depth, gingival recession relative clinical attachment level and Periodontal Inflamed Surface Area (PISA) index) and blood collection for assessment serum inflammatory markers (oxLDL, LDL, HDL, total cholesterol, triglyceride, Interleukin (IL) IL-6, IL-8, IL-10, Tumor Necrosis Factor (TNF-α) and CRP). Biochemical analyzes will be carried out by Z-scan technique. The data obtained before and after periodontal therapy will be analyzed using the Shapiro-Wilk test.
- Being tested
- Non-surgical periodontal treatment
- Keywords
- Periodontal Disease, Type 2 Diabetes Mellitus, Z-scan, Atherosclerosis
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Type 2, Atherosclerosis
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
Debridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment .
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes mellitus and periodontitis | Sham comparator | periodontal debridement in a single session. Receives: Procedure: Non-surgical periodontal treatment |
| Type 2 diabetes mellitus and without periodontitis | No intervention | maintained every three months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth change
The change in the probing depth will be measure in millimeters before and after the treatment.
Measured: baseline, 90 and 180 days
Secondary outcomes (6)
oxLDL concentration Change
Change in concentration of oxLDL will be measured before and treatment.
Measured: baseline and 180 days
LDL, HDL, Total cholesterol, Triacylglycerol
Blood concentration (g/ml) will be measured before and after periodontal therapy.
Measured: baseline and 180 days
Plaque index
Number of teeth affected before and after periodontal treatment
Measured: baseline, 90 and 180 days
Gingival index
number of teeth affected before and after periodontal treatment
Measured: baseline, 90 and 180 days
Gingival Recession
Evaluated in millimeters before and after the treatment.
Measured: baseline, 90 and 180 days
Clinical Attachment Level
Evaluated in millimeters before and after the treatment.
Measured: baseline, 90 and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start2 May 2016
- Primary completion26 Aug 2016
- Study completion28 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus With Periodontal DiseaseStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective double-blind controlled clinical study with a 6-month follow-up.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Collaborators
- LabviVale
- Responsible party
- Principal investigator, Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Maria Jardini, PhD, Study director, Universidade Estadual Paulista Julio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198832
- Sponsor's protocol ID
- CAAE:53785516.6.0000.0077
- Status last verified
- Nov 2018
- First submitted
- 6 Feb 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Periodontal Influence on Markers of Cardiovascular in Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT03198832
- Acronym / sponsor ID
- CAAE:53785516.6.0000.0077
- Keywords
- Periodontal Disease, Type 2 Diabetes Mellitus, Z-scan, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Collaborators
- LabviVale
- Study start
- 2 May 2016 (actual)
- Primary completion
- 26 Aug 2016 (actual)
- Study completion
- 28 Jan 2017 (actual)
- First posted
- 26 Jun 2017 (actual)
- 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.
Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters.
Detailed description
Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters. 44 patients will be divided into 2 groups: Diabetic Patients with Chronic Periodontitis (DM2DP) and Diabetic Patients without Chronic Periodontitis (DM2). The DM2DP group will receive periodontal debridement and DM2 group will be treated with supragingival scaling. Both groups receive board control every 3 months. At baseline, 3 and 6 months after treatment, will be held making the clinical periodontal parameters (plaque index, gingival index, probing depth, gingival recession relative clinical attachment level and Periodontal Inflamed Surface Area (PISA) index) and blood collection for assessment serum inflammatory markers (oxLDL, LDL, HDL, total cholesterol, triglyceride, Interleukin (IL) IL-6, IL-8, IL-10, Tumor Necrosis Factor (TNF-α) and CRP). Biochemical analyzes will be carried out by Z-scan technique. The data obtained before and after periodontal therapy will be analyzed using the Shapiro-Wilk test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective double-blind controlled clinical study with a 6-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes mellitus and periodontitis | Sham comparator | Procedure: Non-surgical periodontal treatmentperiodontal debridement in a single session. |
| Type 2 diabetes mellitus and without periodontitis | No intervention | –maintained every three months. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- individuals older than 35 years with DM2 diagnosed for more than five years and HbA1c between 7% and 11%;
- be diagnosed with generalized chronic periodontitis: present at least 6 sites with periodontal pocket and loss of insertion above 5mm and two more bags with loss of insertion above 6mm;
- present at least 20 teeth;
- agree to participate in the study and sign the informed consent form
Key exclusion criteria (6 listed)
- patients with cardiovascular diseases, cancer, gastrointestinal disorders, skin diseases, pregnancy, lactation, smoking, arthritis, lupus or other diseases of inflammatory origin;
- have undergone periodontal treatment in the last 12 months;
- have made use of antioxidant supplements, anti-inflammatories, or antibiotics within the previous 3 months;
- make use of medications that can alter the marking and concentration of oxLDL, for example, statins;
- have changed the medication for glycemic control in the last 3 months;
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 treatmentDebridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment . | Procedure or surgery | Type 2 diabetes mellitus and periodontitis |
Primary outcome
Probing depth change
Time frame: baseline, 90 and 180 days
The change in the probing depth will be measure in millimeters before and after the treatment.
6 secondary outcomes
oxLDL concentration Change
Time frame: baseline and 180 days
LDL, HDL, Total cholesterol, Triacylglycerol
Time frame: baseline and 180 days
Plaque index
Time frame: baseline, 90 and 180 days
Gingival index
Time frame: baseline, 90 and 180 days
Gingival Recession
Time frame: baseline, 90 and 180 days
Clinical Attachment Level
Time frame: baseline, 90 and 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Maria Jardini, PhD study director
Universidade Estadual Paulista Julio de Mesquita Filho
1 site 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 Type 2 Diabetes Mellitus With Periodontal Disease, run by Universidade Estadual Paulista Júlio de Mesquita Filho 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 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth change (time frame: baseline, 90 and 180 days). 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 14 Nov 2018.