Periodontal Profile of Hypogonadic Men

Phase 4

Withdrawn

• Conditions: Periodontitis; Hypogonadism, Male
• Interventions: Drug: Placebos; Drug: Testosterone gel

• Registration Number: NCT03176537
• Lead Sponsor: Universidade Federal do Paraná

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-14
• Last Update Posted: 2020-04-16
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Gel, daily
TRT	Testosterone gel	Testosterone Replacement Therapy

Primary Outcome Measures

Name	Time	Method
CAL	4.5 months	Clinical Attachment Loss

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clínica de Odontologia da Universidade Federal do Paraná; 🇧🇷 Curitiba, PR, Brazil