Periodontal Profile of Hypogonadic Men

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03176537

Enrollment

Registered

2017-06-05

Start date

2017-05-01

Completion date

2020-12-31

Last updated

2020-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism, Male, Periodontitis

Brief 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.

Interventions

DRUGTestosterone gel

Androgel (50mg testosterone), gel, daily

DRUGPlacebos

Placebo, gel, daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Placebo

Intervention model description

Placebo and TRT groups

Eligibility

Sex/Gender

MALE

Age

30 Years to No maximum

Healthy volunteers

Yes

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. \-

Design outcomes

Primary

Measure	Time frame	Description
CAL	4.5 months	Clinical Attachment Loss

Secondary

Measure	Time frame	Description
PPD	4.5months	probing pocket depth
BOP	3months	bleeding on probing
Micro-organisms concentration	4.5months	DNA hybridization - checkerboard
Concentration of inflammatory markers in crevicular fluid	3months	Multiplex assay

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026