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Periodontal Profile of Hypogonadic Men

NCT ID: NCT03176537

Last Updated: 2020-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Periodontitis Hypogonadism, Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

"Placebo" and "TRT" groups
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Placebo

Study Groups

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Placebo

Gel, daily

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo, gel, daily

TRT

Testosterone Replacement Therapy

Group Type EXPERIMENTAL

Testosterone gel

Intervention Type DRUG

Androgel (50mg testosterone), gel, daily

Interventions

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Testosterone gel

Androgel (50mg testosterone), gel, daily

Intervention Type DRUG

Placebos

Placebo, gel, daily

Intervention Type DRUG

Other Intervention Names

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TRT

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Estadual Paulista - UNESP

UNKNOWN

Sponsor Role collaborator

Universidade de Guarulhos

UNKNOWN

Sponsor Role collaborator

Universidade Federal do Paraná

OTHER

Sponsor Role lead

Responsible Party

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Joao Paulo Steffens

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joao P Steffens, PhD

Role: PRINCIPAL_INVESTIGATOR

UFPR

Locations

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Clínica de Odontologia da Universidade Federal do Paraná

Curitiba, Paraná, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 26450018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26062840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16805680 (View on PubMed)

Other Identifiers

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1.906.729

Identifier Type: -

Identifier Source: org_study_id

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