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Clinical Trials/NCT03176537
NCT03176537WithdrawnPhase 4

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

Universidade Federal do Paraná1 site in 1 countryStarted: May 1, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Withdrawn
Locations
1
Primary Endpoint
CAL

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

Placebo

Eligibility Criteria

Ages
30 Years to — (Adult, Older Adult)
Sex
Male
Accepts 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.

Arms & Interventions

Placebo

Placebo Comparator

Gel, daily

Intervention: Placebos (Drug)

TRT

Experimental

Testosterone Replacement Therapy

Intervention: Testosterone gel (Drug)

Outcomes

Primary Outcomes

CAL

Time Frame: 4.5 months

Clinical Attachment Loss

Secondary Outcomes

  • PPD(3months)
  • Micro-organisms concentration(3months)
  • Concentration of inflammatory markers in crevicular fluid(4.5 months)
  • BOP(4.5months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joao Paulo Steffens

PhD

Universidade Federal do Paraná

Study Sites (1)

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