Periodontal Profile of Hypogonadic Men
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Status
Sponsors
Universidade Federal do Paraná
Collaborators
Universidade Estadual Paulista - UNESP
Universidade de Guarulhos
CLINICAL TRIAL: NCT03176537
BioSeek: nct03176537
Keywords
Abstract
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.
Dates
| Last Verified: | 03/31/2020 |
| First Submitted: | 05/31/2017 |
| Estimated Enrollment Submitted: | 05/31/2017 |
| First Posted: | 06/04/2017 |
| Last Update Submitted: | 04/13/2020 |
| Last Update Posted: | 04/15/2020 |
| Actual Study Start Date: | 04/30/2017 |
| Estimated Primary Completion Date: | 12/30/2020 |
| Estimated Study Completion Date: | 12/30/2020 |
Condition or disease
Periodontitis
Hypogonadism, Male
Intervention/treatment
Drug: TRT
Drug: Placebo
Phase
Phase 4
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Placebo Gel, daily | Drug: Placebo Placebo, gel, daily |
| Experimental: TRT Testosterone Replacement Therapy | Drug: TRT Androgel (50mg testosterone), gel, daily |
Eligibility Criteria
| Ages Eligible for Study | 30 Years To 30 Years |
| Sexes Eligible for Study | Male |
| Accepts Healthy Volunteers | Yes |
| 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. - |
Outcome
Primary Outcome Measures
1. CAL [4.5 months]
Clinical Attachment Loss
Secondary Outcome Measures
1. PPD [4.5months]
probing pocket depth
2. PPD [3months]
probing pocket depth
3. BOP [3months]
bleeding on probing
4. BOP [4.5months]
bleeding on probing
5. Micro-organisms concentration [4.5months]
DNA hybridization - checkerboard
6. Micro-organisms concentration [3months]
DNA hybridization - checkerboard
7. Concentration of inflammatory markers in crevicular fluid [3months]
Multiplex assay
8. Concentration of inflammatory markers in crevicular fluid [4.5 months]
Multiplex assay
