Periodontal Profile of Hypogonadic Men

Universidade Federal do Paraná

Status and phase: Withdrawn; Phase 4

Conditions: Periodontitis; Hypogonadism, Male

Treatments: Drug: Testosterone gel; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03176537

1.906.729

Details and patient eligibility

About

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.

Sex: Male

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Gel, daily

Treatment:

Drug: Placebos

TRT

Experimental group

Description:

Testosterone Replacement Therapy

Treatment:

Drug: Testosterone gel