Periodontal Profile of Hypogonadic Men

Periodontitis Clinical Trial

Official title:

Clinical, Microbiologic and Immunologic Profile of the Periodontal Condition in Hypogonadic Men

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03176537
• Other study ID #: 1.906.729
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2020
• Source: Universidade Federal do Paraná
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadism, Male
• Periodontitis

Intervention

Drug:
• Testosterone gel
Androgel (50mg testosterone), gel, daily
• Placebos
Placebo, gel, daily

Locations

Country	Name	City	State
Brazil	Clínica de Odontologia da Universidade Federal do Paraná	Curitiba	PR

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Federal do Paraná	Universidade de Guarulhos, Universidade Estadual Paulista - UNESP

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAL	Clinical Attachment Loss	4.5 months
Secondary	PPD	probing pocket depth	4.5months
Secondary	PPD	probing pocket depth	3months
Secondary	BOP	bleeding on probing	3months
Secondary	BOP	bleeding on probing	4.5months
Secondary	Micro-organisms concentration	DNA hybridization - checkerboard	4.5months
Secondary	Micro-organisms concentration	DNA hybridization - checkerboard	3months
Secondary	Concentration of inflammatory markers in crevicular fluid	Multiplex assay	3months
Secondary	Concentration of inflammatory markers in crevicular fluid	Multiplex assay	4.5 months