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Periodontal Profile of Hypogonadic Men

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ClinicalTrials.gov Identifier: NCT03176537
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Collaborators:
Universidade Estadual Paulista - UNESP
Universidade de Guarulhos
Information provided by (Responsible Party):
Joao Paulo Steffens, 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.

Condition or disease Intervention/treatment Phase
Periodontitis Hypogonadism, Male Drug: Testosterone gel Drug: Placebos Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: "Placebo" and "TRT" groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo
Primary Purpose: Treatment
Official Title: Clinical, Microbiologic and Immunologic Profile of the Periodontal Condition in Hypogonadic Men
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Gel, daily
Drug: Placebos
Placebo, gel, daily

Experimental: TRT
Testosterone Replacement Therapy
Drug: Testosterone gel
Androgel (50mg testosterone), gel, daily
Other Name: TRT




Primary Outcome Measures :
  1. CAL [ Time Frame: 4.5 months ]
    Clinical Attachment Loss


Secondary Outcome Measures :
  1. PPD [ Time Frame: 4.5months ]
    probing pocket depth

  2. PPD [ Time Frame: 3months ]
    probing pocket depth

  3. BOP [ Time Frame: 3months ]
    bleeding on probing

  4. BOP [ Time Frame: 4.5months ]
    bleeding on probing

  5. Micro-organisms concentration [ Time Frame: 4.5months ]
    DNA hybridization - checkerboard

  6. Micro-organisms concentration [ Time Frame: 3months ]
    DNA hybridization - checkerboard

  7. Concentration of inflammatory markers in crevicular fluid [ Time Frame: 3months ]
    Multiplex assay

  8. Concentration of inflammatory markers in crevicular fluid [ Time Frame: 4.5 months ]
    Multiplex assay



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: total testosterone <200ng/dL in two assessments; at least 20 teeth present.

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Exclusion Criteria: systemic diseases such as hormonal, inflammatory and immune alterations.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176537


Contacts
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Contact: Stephanie C Warnavin, DDS +5547999158292 testosterona.ufpr@gmail.com

Locations
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Brazil
Clínica de Odontologia da Universidade Federal do Paraná Recruiting
Curitiba, PR, Brazil, 80210170
Contact: Joao P Steffens, PhD    +554133604032    joao.steffens@ufpr.br   
Sub-Investigator: Stephanie C Warnavin, DDS         
Principal Investigator: Joao P Steffens, PhD         
Sponsors and Collaborators
Universidade Federal do Paraná
Universidade Estadual Paulista - UNESP
Universidade de Guarulhos
Investigators
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Principal Investigator: Joao P Steffens, PhD UFPR

Publications:
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Responsible Party: Joao Paulo Steffens, PhD, Universidade Federal do Paraná
ClinicalTrials.gov Identifier: NCT03176537     History of Changes
Other Study ID Numbers: 1.906.729
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Periodontitis
Hypogonadism
Eunuchism
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents