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Periodontal Profile of Hypogonadic Men

Primary Purpose

Periodontitis, Hypogonadism, Male

Status
Withdrawn
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Testosterone gel
Placebos
Sponsored by
Universidade Federal do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Clínica de Odontologia da Universidade Federal do Paraná

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

TRT

Arm Description

Gel, daily

Testosterone Replacement Therapy

Outcomes

Primary Outcome Measures

CAL
Clinical Attachment Loss

Secondary Outcome Measures

PPD
probing pocket depth
PPD
probing pocket depth
BOP
bleeding on probing
BOP
bleeding on probing
Micro-organisms concentration
DNA hybridization - checkerboard
Micro-organisms concentration
DNA hybridization - checkerboard
Concentration of inflammatory markers in crevicular fluid
Multiplex assay
Concentration of inflammatory markers in crevicular fluid
Multiplex assay

Full Information

First Posted
June 1, 2017
Last Updated
April 14, 2020
Sponsor
Universidade Federal do Paraná
Collaborators
Universidade Estadual Paulista - UNESP, Universidade de Guarulhos
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1. Study Identification

Unique Protocol Identification Number
NCT03176537
Brief Title
Periodontal Profile of Hypogonadic Men
Official Title
Clinical, Microbiologic and Immunologic Profile of the Periodontal Condition in Hypogonadic Men
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No eligible participants for the RCT were found
Study Start Date
May 1, 2017 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Paraná
Collaborators
Universidade Estadual Paulista - UNESP, Universidade de Guarulhos

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Hypogonadism, Male

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
"Placebo" and "TRT" groups
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Placebo
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Gel, daily
Arm Title
TRT
Arm Type
Experimental
Arm Description
Testosterone Replacement Therapy
Intervention Type
Drug
Intervention Name(s)
Testosterone gel
Other Intervention Name(s)
TRT
Intervention Description
Androgel (50mg testosterone), gel, daily
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo, gel, daily
Primary Outcome Measure Information:
Title
CAL
Description
Clinical Attachment Loss
Time Frame
4.5 months
Secondary Outcome Measure Information:
Title
PPD
Description
probing pocket depth
Time Frame
4.5months
Title
PPD
Description
probing pocket depth
Time Frame
3months
Title
BOP
Description
bleeding on probing
Time Frame
3months
Title
BOP
Description
bleeding on probing
Time Frame
4.5months
Title
Micro-organisms concentration
Description
DNA hybridization - checkerboard
Time Frame
4.5months
Title
Micro-organisms concentration
Description
DNA hybridization - checkerboard
Time Frame
3months
Title
Concentration of inflammatory markers in crevicular fluid
Description
Multiplex assay
Time Frame
3months
Title
Concentration of inflammatory markers in crevicular fluid
Description
Multiplex assay
Time Frame
4.5 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joao P Steffens, PhD
Organizational Affiliation
UFPR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica de Odontologia da Universidade Federal do Paraná
City
Curitiba
State/Province
PR
ZIP/Postal Code
80210170
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26450018
Citation
Steffens JP, Coimbra LS, Rossa C Jr, Kantarci A, Van Dyke TE, Spolidorio LC. Androgen receptors and experimental bone loss - an in vivo and in vitro study. Bone. 2015 Dec;81:683-690. doi: 10.1016/j.bone.2015.10.001. Epub 2015 Oct 9.
Results Reference
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PubMed Identifier
26062840
Citation
Steffens JP, Wang X, Starr JR, Spolidorio LC, Van Dyke TE, Kantarci A. Associations Between Sex Hormone Levels and Periodontitis in Men: Results From NHANES III. J Periodontol. 2015 Oct;86(10):1116-25. doi: 10.1902/jop.2015.140530. Epub 2015 Jun 11.
Results Reference
background
PubMed Identifier
16805680
Citation
Daltaban O, Saygun I, Bolu E. Periodontal status in men with hypergonadotropic hypogonadism: effects of testosterone deficiency. J Periodontol. 2006 Jul;77(7):1179-83. doi: 10.1902/jop.2006.050286.
Results Reference
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Periodontal Profile of Hypogonadic Men

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