Clinical trial NCT03176537: Periodontal Profile of Hypogonadic Men
Official title: Clinical, Microbiologic and Immunologic Profile of the Periodontal Condition in Hypogonadic Men
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Periodontitis
Hypogonadism, Male
Lead sponsor: Universidade Federal do Paraná
Sponsor class: OTHER
Collaborators: name: Universidade Estadual Paulista - UNESP
name: Universidade de Guarulhos
First posted: 2017-06-05
Enrollment: 0
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: "Placebo" and "TRT" groups
Primary purpose: TREATMENT

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.


Eligibility 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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Primary outcomes:
measure: CAL
timeFrame: 4.5 months
Secondary outcomes:
measure: PPD
timeFrame: 4.5months
measure: PPD
timeFrame: 3months
measure: BOP
timeFrame: 3months
measure: BOP
timeFrame: 4.5months
measure: Micro-organisms concentration
timeFrame: 4.5months
measure: Micro-organisms concentration
timeFrame: 3months
measure: Concentration of inflammatory markers in crevicular fluid
timeFrame: 3months
measure: Concentration of inflammatory markers in crevicular fluid
timeFrame: 4.5 months
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Clínica de Odontologia da Universidade Federal do Paraná
state: PR
Study officials:
affiliation: UFPR
name: Joao P Steffens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.