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PeriodontitisPhase 4NCT03176537

Periodontal Profile of Hypogonadic Men

A Phase 4 study testing Testosterone gel in people with Periodontitis and Hypogonadism, Male, run by Universidade Federal do Paraná at 1 site in Brazil.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The aim of this study is to assess if hypogonadic men with periodontitis benefit from testosterone replacement therapy before being submitted to periodontal treatment. Fifty hypogonadic men (Total Testosterone <200ng/dL) will be recruited from the Clinics Hospital at Federal University of Paraná and subjected to… Read more about this study

Who is it for?
Ages 30 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Periodontitis, Hypogonadism, Male
What is being tested?
Testosterone gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteBrazil
Study dates
1 May 2017to 31 Dec 2020
Phase
Phase 4
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 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Inclusion Criteria: total testosterone <200ng/dL in two assessments; at least 20 teeth present.

-

Exclusion Criteria: systemic diseases such as hormonal, inflammatory and immune alterations.

-

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Clínica de Odontologia da Universidade Federal do Paraná

    Curitiba, Paraná, 80210170

Other trials in Brazil

About this study

Official title: Clinical, Microbiologic and Immunologic Profile of the Periodontal Condition in Hypogonadic Men

The aim of this study is to assess if hypogonadic men with periodontitis benefit from testosterone replacement therapy before being submitted to periodontal treatment. Fifty hypogonadic men (Total Testosterone <200ng/dL) will be recruited from the Clinics Hospital at Federal University of Paraná and subjected to periodontal evaluation by a trained and calibrated researcher. The subjects presenting with periodontitis (assessed by clinical parameters) will be randomly allocated to "testosterone replacement therapy" (TRT) group or "placebo" for 3 months. After that time, all patients will receive nonsurgical periodontal treatment, which will be reassessed after 45 days. Clinical parameters (such as probing depth, gingival and plaque index, clinical attachment loss, bleeding on probing), sub gingival plaque and gingival crevicular fluid will be collected at baseline, just before therapy and 45 days after therapy.

Being tested
Testosterone gel, Placebos
Medical subject headings
Periodontitis, Eunuchism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Testosterone gelDrug

    Also called TRT

    Androgel (50mg testosterone), gel, daily

  • PlacebosDrug

    Placebo, gel, daily

Study groups in NCT03176537
Study groupRoleWhat they receive
PlaceboPlacebo comparatorGel, daily
Receives: Drug: Placebos
TRTExperimentalTestosterone Replacement Therapy
Receives: Drug: Testosterone gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CAL

    Clinical Attachment Loss

    Measured: 4.5 months

Secondary outcomes (8)

  1. PPD

    probing pocket depth

    Measured: 4.5months

  2. PPD

    probing pocket depth

    Measured: 3months

  3. BOP

    bleeding on probing

    Measured: 3months

  4. BOP

    bleeding on probing

    Measured: 4.5months

  5. Micro-organisms concentration

    DNA hybridization - checkerboard

    Measured: 4.5months

  6. Micro-organisms concentration

    DNA hybridization - checkerboard

    Measured: 3months

  7. Concentration of inflammatory markers in crevicular fluid

    Multiplex assay

    Measured: 3months

  8. Concentration of inflammatory markers in crevicular fluid

    Multiplex assay

    Measured: 4.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2017
  2. Study start1 May 2017 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Why it stopped: No eligible participants for the RCT were found

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
"Placebo" and "TRT" groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03176537
Sponsor's protocol ID
1.906.729
Status last verified
Apr 2020
First submitted
1 Jun 2017
Last updated
16 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Steffens JP, Coimbra LS, Rossa C Jr, Kantarci A, Van Dyke TE, Spolidorio LC. Androgen receptors and experimental bone loss - an in vivo and in vitro study. Bone. 2015 Dec;81:683-690. doi: 10.1016/j.bone.2015.10.001. Epub 2015 Oct 9.

    PubMed 26450018

  • Steffens JP, Wang X, Starr JR, Spolidorio LC, Van Dyke TE, Kantarci A. Associations Between Sex Hormone Levels and Periodontitis in Men: Results From NHANES III. J Periodontol. 2015 Oct;86(10):1116-25. doi: 10.1902/jop.2015.140530. Epub 2015 Jun 11.

    PubMed 26062840

  • Daltaban O, Saygun I, Bolu E. Periodontal status in men with hypergonadotropic hypogonadism: effects of testosterone deficiency. J Periodontol. 2006 Jul;77(7):1179-83. doi: 10.1902/jop.2006.050286.

    PubMed 16805680

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Testosterone gel in people with Periodontitis and Hypogonadism, Male, run by Universidade Federal do Paraná 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?

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: withdrawn, as of the sponsor's last update on 16 Apr 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. 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?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

CAL (time frame: 4.5 months). 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 NCT03176537, which also lists 3 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 16 Apr 2020.

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