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Periodontal Profile of Hypogonadic Men

NCT03176537 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-04-16

No results posted yet for this 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.

Conditions

  • Periodontitis
  • Hypogonadism, Male

Interventions

DRUG

Testosterone gel

Androgel (50mg testosterone), gel, daily

DRUG

Placebos

Placebo, gel, daily

Sponsors & Collaborators

  • Universidade Estadual Paulista - UNESP

    collaborator UNKNOWN

  • Universidade de Guarulhos

    collaborator UNKNOWN

  • Universidade Federal do Paraná

    lead OTHER

Principal Investigators

  • Joao P Steffens, PhD · UFPR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176537 on ClinicalTrials.gov