HIV/AIDSNCT03262402
Effects of Periodontal Treatment on HIV-infected Patients
A study testing Basic periodontal treatment in people with HIV/AIDS and Periodontal Diseases, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Periodontal diseases, such as chronic periodontitis (CP), frequently occur in immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by the HIV infection can justify the high frequency and the difficult in controlling the CP in this group of patients, raising the possibility of… Read more about this study
- Who is it for?
- Ages 36 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Periodontal Diseases
- What is being tested?
- Basic periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jul 2017to 8 Apr 2019
- 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 36 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General for both groups/arms: Patients with at least 15 teeth; with chronic periodontitis (at least 2 sites with pocket probing depth ≥ 5mm and clinical attachment loss >4mm); no use of antibiotics for the 6 months previous to study enrolment.
- For HIV-infected group: CD4 T lymphocytes < 200 cel/mm3, stable HAART for the 6 months previous to study enrollment.
Who cannot join
- General for both groups/arms: periodontal treatment and use of antibiotics for the 6 months previous to study enrollment; smoking; complex systemic conditions.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry of Ribeirão Preto, University of São Paulo
Ribeirão Preto, São Paulo, 14040-904
About this study
Official title: Determination of Factors Involved in the Pathogenesis of Periodontal Diseases in HIV-infected Patients
Periodontal diseases, such as chronic periodontitis (CP), frequently occur in immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by the HIV infection can justify the high frequency and the difficult in controlling the CP in this group of patients, raising the possibility of additional factors associated to the development of CP in HIV patients. The aim of this study is to determine factors that can be involved in the CP pathogenesis in HIV patients, including Candida spp presence, and biomarkers involved on the inflammatory response against the microorganisms.
Read the detailed description
Investigators will develop one quasi-experimental study in HIV patients (N=15) and non-HIV patients (N=15) presenting CP. Candida spp count and salivary and gingival crevicular fluid concentrations of histatin, lactoferrin, interleukin-1β, interleukin-6, and tumor necrosis factor-α will be determined at baseline, 30 and 90 days after the periodontal treatment. In order to minimize the influence of the immunosuppressive condition, patients have to present CD4 T lymphocytes < 200cel/mm3 blood count, non-detectable viral load and the same protocol of antiretroviral therapy. Additionally, investigators intend to determine the immunophenotypic profile of the gingival tissue through immunohistochemical analysis. This study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto (CAAE: 50004415.1.0000.5419), and all patients need to provide written informed consent.
- Conditions
- HIV/AIDS, Periodontal Diseases
- Being tested
- Basic periodontal treatment
- Keywords
- Chronic periodontitis, Candida spp, Histatin-5, Lactoferrin
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Periodontal Diseases, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic periodontal treatmentProcedure or surgery
Also called Non-surgical periodontal treatment
Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected group | Experimental | Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis. Receives: Procedure: Basic periodontal treatment |
| Non-HIV infected group | Active comparator | Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis. Receives: Procedure: Basic periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical signs of chronic periodontitis.
Clinical parameters of the periodontal diseases: Dental biofilm index and bleeding on probing (BOP) measured in percentage associated to pocket probing depth (PPD) and clinical attachment loss (CAL) measured in millimeters will be combined to report the effect of periodontal treatment on the chronic periodontitis in percentage of sites with no periodontal diseases signs.
Measured: Baseline, 30 days and 90 days.
Secondary outcomes (3)
Change in Candida spp carriage.
Number of Candida spp colonies on culture plates.
Measured: Baseline, 30 days and 90 days.
Change in salivary biomarkers
Concentrations of histatin, lactoferrin and inflammatory cytokines in saliva and gingival crevicular fluid in pg/mL.
Measured: Baseline, 30 days and 90 days.
Change in bacterial microbiota
Pyrosequencing characterization of the bacterial microbiota
Measured: Baseline, 30 days and 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start2 Jul 2017
- Primary completion2 Aug 2018
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Carolina Fragoso Motta, DDS, PhD, University of Sao Paulo
- Investigators
- Ana Carolina F Motta, DDS, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262402
- Sponsor's protocol ID
- CAAE: 50004415.1.0000.5419
- Status last verified
- Mar 2020
- First submitted
- 19 Aug 2017
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data of all primary and secondary outcomes will be made available.
Publications
Lourenco AG, Ribeiro AERA, Nakao C, Motta ACF, Antonio LGL, Machado AA, Komesu MC. Oral Candida spp carriage and periodontal diseases in HIV-infected patients in Ribeirao Preto, Brazil. Rev Inst Med Trop Sao Paulo. 2017 Jun 1;59:e29. doi: 10.1590/S1678-9946201759029.
PubMed 28591257Lourenco AG, Rodrigues Alves Ribeiro AE, Nakao C, Fragoso Motta AC, Machado AA, Komesu MC. Influence of antiretroviral therapy and periodontal disease on human salivary beta-defensin 2 in patients infected with HIV. Curr HIV Res. 2014;12(1):44-9. doi: 10.2174/1570162x12666140407125120.
PubMed 24720483
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Factors Involved in the Pathogenesis of Periodontal Diseases in HIV-infected Patients
- ClinicalTrials.gov ID
- NCT03262402
- Acronym / sponsor ID
- CAAE: 50004415.1.0000.5419
- Conditions
- HIV/AIDS, Periodontal Diseases
- Keywords
- Chronic periodontitis, Candida spp, Histatin-5, Lactoferrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 Jul 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 25 Aug 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 diseases, such as chronic periodontitis (CP), frequently occur in immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by the HIV infection can justify the high frequency and the difficult in controlling the CP in this group of patients, raising the possibility of additional factors associated to the development of CP in HIV patients. The aim of this study is to determine factors that can be involved in the CP pathogenesis in HIV patients, including Candida spp presence, and biomarkers involved on the inflammatory response against the microorganisms.
Detailed description
Investigators will develop one quasi-experimental study in HIV patients (N=15) and non-HIV patients (N=15) presenting CP. Candida spp count and salivary and gingival crevicular fluid concentrations of histatin, lactoferrin, interleukin-1β, interleukin-6, and tumor necrosis factor-α will be determined at baseline, 30 and 90 days after the periodontal treatment. In order to minimize the influence of the immunosuppressive condition, patients have to present CD4 T lymphocytes < 200cel/mm3 blood count, non-detectable viral load and the same protocol of antiretroviral therapy. Additionally, investigators intend to determine the immunophenotypic profile of the gingival tissue through immunohistochemical analysis. This study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto (CAAE: 50004415.1.0000.5419), and all patients need to provide written informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-infected group | Experimental | Procedure: Basic periodontal treatmentPatients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis. |
| Non-HIV infected group | Active comparator | Procedure: Basic periodontal treatmentPatients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis. |
Who may qualify
- Ages
- 36 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- General for both groups/arms: Patients with at least 15 teeth; with chronic periodontitis (at least 2 sites with pocket probing depth ≥ 5mm and clinical attachment loss >4mm); no use of antibiotics for the 6 months previous to study enrolment.
- For HIV-infected group: CD4 T lymphocytes < 200 cel/mm3, stable HAART for the 6 months previous to study enrollment.
Key exclusion criteria (1 listed)
- General for both groups/arms: periodontal treatment and use of antibiotics for the 6 months previous to study enrollment; smoking; complex systemic conditions.
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 |
|---|---|---|
| Basic periodontal treatmentAlso: Non-surgical periodontal treatmentBasic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments. | Procedure or surgery | HIV-infected group, Non-HIV infected group |
Primary outcome
Change in clinical signs of chronic periodontitis.
Time frame: Baseline, 30 days and 90 days.
Clinical parameters of the periodontal diseases: Dental biofilm index and bleeding on probing (BOP) measured in percentage associated to pocket probing depth (PPD) and clinical attachment loss (CAL) measured in millimeters will be combined to report the effect of periodontal treatment on the chronic periodontitis in percentage of sites with no periodontal diseases signs.
3 secondary outcomes
Change in Candida spp carriage.
Time frame: Baseline, 30 days and 90 days.
Change in salivary biomarkers
Time frame: Baseline, 30 days and 90 days.
Change in bacterial microbiota
Time frame: Baseline, 30 days and 90 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 27 Mar 2020.
- Background: PubMed 28591257Lourenco AG, Ribeiro AERA, Nakao C, Motta ACF, Antonio LGL, Machado AA, Komesu MC. Oral Candida spp carriage and periodontal diseases in HIV-infected patients in Ribeirao Preto, Brazil. Rev Inst Med Trop Sao Paulo. 2017 Jun 1;59:e29. doi: 10.1590/S1678-9946201759029.
- Background: PubMed 24720483Lourenco AG, Rodrigues Alves Ribeiro AE, Nakao C, Fragoso Motta AC, Machado AA, Komesu MC. Influence of antiretroviral therapy and periodontal disease on human salivary beta-defensin 2 in patients infected with HIV. Curr HIV Res. 2014;12(1):44-9. doi: 10.2174/1570162x12666140407125120.
- Individual participant dataSharing planned: Yes. Individual participant data of all primary and secondary outcomes will be made available.
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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.
Ana Carolina F Motta, DDS, PhD principal investigator
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 study testing Basic periodontal treatment in people with HIV/AIDS and Periodontal Diseases, 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 2 inclusion and 1 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 27 Mar 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 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?
Change in clinical signs of chronic periodontitis. (time frame: Baseline, 30 days and 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03262402, which also lists 2 linked publications.
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 27 Mar 2020.