CClinicalTrials.gg
Sign In
WithdrawnNCT03176537Updated Apr 16, 2020

Periodontal Profile of Hypogonadic Men

A Phase 4 interventional study of Testosterone gel and Placebos in Periodontitis and Hypogonadism, Male, sponsored by Universidade Federal do Paraná. Withdrawn at 1 site in Brazil. Open to male participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-16.

Sponsored by Universidade Federal do Paraná · Phase 4, Interventional, and Treatment

Why this study was withdrawn
No eligible participants for the RCT were found
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
30 Years and older
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Periodontitis
  • Hypogonadism, Male
03

Who can participate

Ages eligible
30 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

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.

-

04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Gel, daily

    Drug: Placebos

  • Experimental
    TRT

    Testosterone Replacement Therapy

    Drug: Testosterone gel

Interventions

  • DrugTestosterone gel

    Androgel (50mg testosterone), gel, daily

    Also known as: TRT

  • DrugPlacebos

    Placebo, gel, daily

05

What researchers measure

Primary outcomes

  1. CAL

    Clinical Attachment Loss

    Time frame: 4.5 months

Secondary outcomes

  1. PPD

    probing pocket depth

    Time frame: 4.5months

  2. PPD

    probing pocket depth

    Time frame: 3months

  3. BOP

    bleeding on probing

    Time frame: 3months

  4. BOP

    bleeding on probing

    Time frame: 4.5months

  5. Micro-organisms concentration

    DNA hybridization - checkerboard

    Time frame: 4.5months

  6. Micro-organisms concentration

    DNA hybridization - checkerboard

    Time frame: 3months

  7. Concentration of inflammatory markers in crevicular fluid

    Multiplex assay

    Time frame: 3months

  8. Concentration of inflammatory markers in crevicular fluid

    Multiplex assay

    Time frame: 4.5 months

06

Study locations

1 site
  • Clínica de Odontologia da Universidade Federal do Paraná
    Curitiba, PR 80210170, Brazil
07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03176537
Lead sponsor
Universidade Federal do Paraná
Collaborators
Universidade Estadual Paulista - UNESP, Universidade de Guarulhos
Responsible party
Joao Paulo Steffens (PhD, Universidade Federal do Paraná) — Principal investigator
First posted
Jun 5, 2017
Start date
May 1, 2017 (estimated)
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Apr 16, 2020

Study contacts

Joao P Steffens, PhD
principal investigator · UFPR

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Periodontitis→

Other studies from this sponsor

Universidade Federal do Paraná

Start the discussion