Chronic PeriodontitisNCT02589314
Effect of Periodontal Therapy in the Systemic Status of Individuals With Chronic Periodontitis and Diabetes Type 2
An observational study of Chronic Periodontitis and Diabetes Type 2, run by University of Brasilia at 1 site in Brazil.
Trial summary
This study will evaluate if periodontal mechanical treatment is capable to alter immunological and genetical parameters related to systemic health in patients with chronic periodontitis ant diabetes type 2. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Diabetes Type 2
- What is being tested?
- Mechanical periodontal therapy and nonsurgical periodontal therapy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2015to Aug 2020
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Periodontitis group:
- Minimum of 15 teeh;
- At least 30% of sites with periodontal probing depth ≥ 4 mm and at least two teeth with CAL ≥ 3 mm; Age ≥30 years;
- Control group:
- Systemically healthy;
- 20 teeth;
- Probing depth ≤3 mm, clinical attachment level ≤3 mm , ≤10% of sites with bleeding on probing.
Who cannot join
- Periodontal treatment in the last six months;
- Continued use of medications such as antibiotics, immunomodulatory, anti-inflammatory drugs or corticosteroids in the last three months;
- Systemic diseases that interfere with periodontal condition, except for diabetes for the test group (HIV, cancer, immune disorders, acute infections, severe allergies, gastrointestinal or kidney disease, morbid obesity [BMI 40 kg / m2] or underweight [evil nourished BMI <18.5 kg / m2], etc.); Pregnant or lactating; smoking; Age <30 years; Indigenous groups.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mechanical Periodontal Therapy in the Microbiological, Immunocellular and Immunoglobulin Profiles and in the Dosage of Pro and Anti-inflammatory Cytokines From Peripheral Blood and Saliva of Subjects With Chronic Periodontitis and Diabetes Type 2
This study will evaluate if periodontal mechanical treatment is capable to alter immunological and genetical parameters related to systemic health in patients with chronic periodontitis ant diabetes type 2.
- Conditions
- Chronic Periodontitis, Diabetes Type 2
- Being tested
- Mechanical periodontal therapy, nonsurgical periodontal therapy
- Medical subject headings
- Chronic Periodontitis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical periodontal therapyDevice
Also called periodontal debridment
nonsurgical periodontal therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| root planning | Not described Receives: Device: Mechanical periodontal therapy; Procedure: nonsurgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of alteration in periodontal pathogens by PCR
Evaluate wich periodontal pathogens are detected before and after treatment
Measured: One year
Evidence of alteration of immunocellular response by flowcytometry
Fenotype Monocytes, PMN, NK cells, T cells, B cells before and after periodontal treatment
Measured: one year
Evidence of alteration on pro and anti-inflammatory cytokines by CBA
Dosage of cytokines before and after periodontal treatment
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2019
- Study completionAug 2020
Why it stopped: We could not achieve the number of participants necessary to continue with the study and limited money to continue with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of Brasília, Brasilia University Hospital
- Responsible party
- Principal investigator, Priscilla Farias Naiff, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589314
- Sponsor's protocol ID
- CAAE 46609515.7.0000.0030
- Status last verified
- Aug 2020
- First submitted
- 26 Oct 2015
- Last updated
- 24 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Periodontal Therapy in the Microbiological, Immunocellular and Immunoglobulin Profiles and in the Dosage of Pro and Anti-inflammatory Cytokines From Peripheral Blood and Saliva of Subjects With Chronic Periodontitis and Diabetes Type 2
- ClinicalTrials.gov ID
- NCT02589314
- Acronym / sponsor ID
- CAAE 46609515.7.0000.0030
- Conditions
- Chronic Periodontitis, Diabetes Type 2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We could not achieve the number of participants necessary to continue with the study and limited money to continue with the study
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- Catholic University of Brasília, Brasilia University Hospital
- Study start
- Nov 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 28 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.
This study will evaluate if periodontal mechanical treatment is capable to alter immunological and genetical parameters related to systemic health in patients with chronic periodontitis ant diabetes type 2.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| root planning | – | Device: Mechanical periodontal therapy, Procedure: nonsurgical periodontal therapy |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Minimum of 15 teeh;
- At least 30% of sites with periodontal probing depth ≥ 4 mm and at least two teeth with CAL ≥ 3 mm; Age ≥30 years;
- Systemically healthy;
- 20 teeth;
- Probing depth ≤3 mm, clinical attachment level ≤3 mm , ≤10% of sites with bleeding on probing.
Key exclusion criteria (3 listed)
- Periodontal treatment in the last six months;
- Continued use of medications such as antibiotics, immunomodulatory, anti-inflammatory drugs or corticosteroids in the last three months;
- Systemic diseases that interfere with periodontal condition, except for diabetes for the test group (HIV, cancer, immune disorders, acute infections, severe allergies, gastrointestinal or kidney disease, morbid obesity [BMI 40 kg / m2] or underweight [evil nourished BMI <18.5 kg / m2], etc.); Pregnant or lactating; smoking; Age <30 years; Indigenous groups.
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 |
|---|---|---|
| Mechanical periodontal therapyAlso: periodontal debridment | Device | root planning |
| nonsurgical periodontal therapy | Procedure or surgery | root planning |
Primary outcome
Evidence of alteration in periodontal pathogens by PCR
Time frame: One year
Evaluate wich periodontal pathogens are detected before and after treatment
Evidence of alteration of immunocellular response by flowcytometry
Time frame: one year
Fenotype Monocytes, PMN, NK cells, T cells, B cells before and after periodontal treatment
Evidence of alteration on pro and anti-inflammatory cytokines by CBA
Time frame: One year
Dosage of cytokines before and after periodontal treatment
Results and safety
The study was stopped early (reason given: We could not achieve the number of participants necessary to continue with the study and limited money to continue with the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis and Diabetes Type 2, run by University of Brasilia 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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 24 Aug 2020. 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?
The study was stopped early (reason given: We could not achieve the number of participants necessary to continue with the study and limited money to continue with the 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?
Evidence of alteration in periodontal pathogens by PCR (time frame: One year). The study lists 3 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 24 Aug 2020.