PeriodontitisPETREBEDNCT03146975
Effects of Gum Disease Treatment on Host Defense Factors
A study testing Non-surgical periodontal treatment in people with Periodontitis and Diabetes Mellitus, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Human immune system produces many different factors, which will influence health-disease statuses. This partially explains why under similar conditions only some people become sick. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Diabetes Mellitus
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Mar 2014to 28 Jun 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Periodontally healthy individuals: at least 15 natural teeth, periodontal pocket depth (PPD) ≤ 3mm e absence of bleeding on probing.
- Periodontitis individuals: at least 15 natural teeth and at least 4 teeth with one or more periodontal sites showing combined PPD ≥ 4mm and clinical attachment level (CAL) ≥ 3mm.
- Compensated diabetic individuals: compensated type 2 diabetes mellitus
- Decompensated diabetic individuals: decompensated type 2 diabetes mellitus (glycated hemoglobin HbA1c >7%)
Who cannot join
- Past or actual systemic diseases other than diabetes type 2 in the diabetic groups
- Gingivitis
- Gingival overgrowth
- Necrotizing periodontal diseases
- Pregnant or lactating
- smokers or former-smokers
Show all 9Show fewer
- medication that can influence periodontal status or host response to periodontal therapy
- periodontal therapy in the past 6 months from baseline
- use of systemic or local antibiotics or anti-inflammatory drugs within 3 months prior baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Non-surgical Periodontal Treatment on Gingival Beta Defensins in Different Clinical Conditions : a Short-term Clinica Trial
Human immune system produces many different factors, which will influence health-disease statuses. This partially explains why under similar conditions only some people become sick. Therefore, specific analyses of such factors in healthy and diseased patients are crucial for a better knowledge about diseases development and successful treatments. Human beta defensins (hBD) may have a key role in patient's susceptibility to gum diseases. In the lab, high levels of sugar (glucose) could inhibit their expression and contribute to the occurrence of infections associated with diabetic wounds. This study will evaluate if treatment of the most common gum disease in adults influences production of beta defensins by gingiva. Also, clinical improvements and treatment effects on blood glycemic levels will be monitored throughout a 2-month period. Patients with or without gum diseases and with or without diabetes mellitus will be able to participate. After a complete oral examination to determine periodontal status, gingival fluid samples will be collected using paper strips. These samples will be collected before and also two-months after oral treatment and will be analyzed by an immune-enzymatic test named ELISA (Enzyme-Linked Immunosorbent Assay). In weekly sections, one trained specialist will performed treatment of gum diseases under local anesthesia using hand-instruments. Researchers hypothesized that a) levels of defensins would be lower in the presence of periodontal disease when compared to a healthy periodontal condition; b) diabetes would influence production of these immune protective factors; and c) treatment would provide a greater beneficial amount of defensins.
- Conditions
- Periodontitis, Diabetes Mellitus
- Being tested
- Non-surgical periodontal treatment
- Keywords
- Beta-defensins, Chronic periodontitis, Diabetes mellitus, Non-surgical periodontal therapy
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Chronic Periodontitis
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
Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | No intervention | Not described |
| Periodontitis without diabetes | Experimental | Not described Receives: Procedure: Non-surgical periodontal treatment |
| Periodontitis compensated diabetes | Experimental | Not described Receives: Procedure: Non-surgical periodontal treatment |
| Periodontitis decompensated diabetes | Experimental | Not described Receives: Procedure: Non-surgical periodontal treatment |
| Compensated diabetes non periodontitis | No intervention | Not described |
| Decompensated diabetes non periodontitis | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in beta defensins 1, 2 and 3
Increase in the expression of beta defensins 1, 2 and 3 in gingival crevicular fluid samples
Measured: Baseline and 60 days
Secondary outcomes (3)
Changes in periodontal pocket depth
Reduction in mean periodontal pocket depth
Measured: Baseline and 60 days
Changes in blood glycemic levels
Reduction in blood glucose levels and levels of glycated hemoglobin
Measured: Baseline and 60 days
Changes in percentage of diseased sites
Reduction in the percentage of sites showing PPD>4mm and/or bleeding on probing
Measured: Baseline and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start2 Mar 2014
- Primary completion20 Jun 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando O Costa, Federal University of Minas Gerais
- Investigators
- Fernando O Costa, PhD, Principal investigator, Dean periodontics department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146975
- Sponsor's protocol ID
- Beta defensins in periodontics
- Acronym
- PETREBED
- Status last verified
- Jun 2017
- First submitted
- 8 May 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Only data without identification will be submitted to statistical analysis.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-surgical Periodontal Treatment on Gingival Beta Defensins in Different Clinical Conditions : a Short-term Clinica Trial
- ClinicalTrials.gov ID
- NCT03146975
- Acronym / sponsor ID
- PETREBED / Beta defensins in periodontics
- Conditions
- Periodontitis, Diabetes Mellitus
- Keywords
- Beta-defensins, Chronic periodontitis, Diabetes mellitus, Non-surgical periodontal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 2 Mar 2014 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 10 May 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.
Human immune system produces many different factors, which will influence health-disease statuses. This partially explains why under similar conditions only some people become sick. Therefore, specific analyses of such factors in healthy and diseased patients are crucial for a better knowledge about diseases development and successful treatments. Human beta defensins (hBD) may have a key role in patient's susceptibility to gum diseases. In the lab, high levels of sugar (glucose) could inhibit their expression and contribute to the occurrence of infections associated with diabetic wounds. This study will evaluate if treatment of the most common gum disease in adults influences production of beta defensins by gingiva. Also, clinical improvements and treatment effects on blood glycemic levels will be monitored throughout a 2-month period. Patients with or without gum diseases and with or without diabetes mellitus will be able to participate. After a complete oral examination to determine periodontal status, gingival fluid samples will be collected using paper strips. These samples will be collected before and also two-months after oral treatment and will be analyzed by an immune-enzymatic test named ELISA (Enzyme-Linked Immunosorbent Assay). In weekly sections, one trained specialist will performed treatment of gum diseases under local anesthesia using hand-instruments. Researchers hypothesized that a) levels of defensins would be lower in the presence of periodontal disease when compared to a healthy periodontal condition; b) diabetes would influence production of these immune protective factors; and c) treatment would provide a greater beneficial amount of defensins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy | No intervention | – |
| Periodontitis without diabetes | Experimental | Procedure: Non-surgical periodontal treatment |
| Periodontitis compensated diabetes | Experimental | Procedure: Non-surgical periodontal treatment |
| Periodontitis decompensated diabetes | Experimental | Procedure: Non-surgical periodontal treatment |
| Compensated diabetes non periodontitis | No intervention | – |
| Decompensated diabetes non periodontitis | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Periodontally healthy individuals: at least 15 natural teeth, periodontal pocket depth (PPD) ≤ 3mm e absence of bleeding on probing.
- Periodontitis individuals: at least 15 natural teeth and at least 4 teeth with one or more periodontal sites showing combined PPD ≥ 4mm and clinical attachment level (CAL) ≥ 3mm.
- Compensated diabetic individuals: compensated type 2 diabetes mellitus
- Decompensated diabetic individuals: decompensated type 2 diabetes mellitus (glycated hemoglobin HbA1c >7%)
Key exclusion criteria (9 listed)
- Past or actual systemic diseases other than diabetes type 2 in the diabetic groups
- Gingivitis
- Gingival overgrowth
- Necrotizing periodontal diseases
- Pregnant or lactating
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 treatmentQuadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions. | Procedure or surgery | Periodontitis compensated diabetes, Periodontitis decompensated diabetes, Periodontitis without diabetes |
Primary outcome
Changes in beta defensins 1, 2 and 3
Time frame: Baseline and 60 days
Increase in the expression of beta defensins 1, 2 and 3 in gingival crevicular fluid samples
3 secondary outcomes
Changes in periodontal pocket depth
Time frame: Baseline and 60 days
Changes in blood glycemic levels
Time frame: Baseline and 60 days
Changes in percentage of diseased sites
Time frame: Baseline and 60 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 2 Jul 2017.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Only data without identification will be submitted to statistical analysis.
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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.
Fernando O Costa, PhD principal investigator
Dean periodontics department
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 Periodontitis and Diabetes Mellitus, run by Federal University of Minas Gerais 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 9 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 2 Jul 2017. 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 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?
Changes in beta defensins 1, 2 and 3 (time frame: Baseline and 60 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 2 Jul 2017.