Clinical, Microbiologic and Immunologic Profile of the Periodontal Condition in Hypogonadic Men
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- Withdrawn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
Gel, daily
Intervention: Placebos (Drug)
TRT
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
Joao Paulo Steffens
PhD
Universidade Federal do Paraná
