Periodontal Profile of Hypogonadic Men

NCT03176537 | Withdrawn Phase 4

• 1 other identifier: 1.906.729
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Hypogonadism, Male

Outcome Measures

Primary Outcomes (1)

• CAL

  Clinical Attachment Loss

  4.5 months

Secondary Outcomes (8)

• PPD

  4.5months

• PPD

  3months

• BOP

  3months

• BOP

  4.5months

• Micro-organisms concentration

  4.5months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Gel, daily

Drug: Placebos

TRT

EXPERIMENTAL

Testosterone Replacement Therapy

Drug: Testosterone gel

Interventions

Testosterone gel DRUG

Androgel (50mg testosterone), gel, daily

Also known as: TRT

TRT

Placebos DRUG

Placebo, gel, daily

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidade Federal do Paraná: lead
• Universidade Estadual Paulista - UNESP: collaborator
• Universidade de Guarulhos: collaborator

Study Sites (1)

Clínica de Odontologia da Universidade Federal do Paraná

Curitiba, Paraná, 80210170, Brazil

Location

Related Publications (3)

• 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.

  PMID: 26450018 BACKGROUND

• 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.

  PMID: 26062840 BACKGROUND

• 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.

  PMID: 16805680 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Eunuchism

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Joao P Steffens, PhD

  UFPR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: "Placebo" and "TRT" groups

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 5, 2017
• Study Start: May 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)