Periodontal Profile of Hypogonadic Men

April 14, 2020 updated by: Joao Paulo Steffens, Universidade Federal do Paraná

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

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 Overview

Status

Withdrawn

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • PR
      • Curitiba, PR, Brazil, 80210170
        • Clínica de Odontologia da Universidade Federal do Paraná

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Gel, daily
Placebo, gel, daily
Experimental: TRT
Testosterone Replacement Therapy
Androgel (50mg testosterone), gel, daily
Other Names:
  • TRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAL
Time Frame: 4.5 months
Clinical Attachment Loss
4.5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPD
Time Frame: 4.5months
probing pocket depth
4.5months
PPD
Time Frame: 3months
probing pocket depth
3months
BOP
Time Frame: 3months
bleeding on probing
3months
BOP
Time Frame: 4.5months
bleeding on probing
4.5months
Micro-organisms concentration
Time Frame: 4.5months
DNA hybridization - checkerboard
4.5months
Micro-organisms concentration
Time Frame: 3months
DNA hybridization - checkerboard
3months
Concentration of inflammatory markers in crevicular fluid
Time Frame: 3months
Multiplex assay
3months
Concentration of inflammatory markers in crevicular fluid
Time Frame: 4.5 months
Multiplex assay
4.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joao P Steffens, PhD, UFPR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

June 1, 2017

First Submitted That Met QC Criteria

June 1, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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