- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03176537
Periodontal Profile of Hypogonadic Men
April 14, 2020 updated by: Joao Paulo Steffens, Universidade Federal do Paraná
Clinical, Microbiologic and Immunologic Profile of the Periodontal Condition in Hypogonadic Men
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
PR
-
Curitiba, PR, Brazil, 80210170
- Clínica de Odontologia da Universidade Federal do Paraná
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Gel, daily
|
Placebo, gel, daily
|
Experimental: TRT
Testosterone Replacement Therapy
|
Androgel (50mg testosterone), gel, daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CAL
Time Frame: 4.5 months
|
Clinical Attachment Loss
|
4.5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PPD
Time Frame: 4.5months
|
probing pocket depth
|
4.5months
|
PPD
Time Frame: 3months
|
probing pocket depth
|
3months
|
BOP
Time Frame: 3months
|
bleeding on probing
|
3months
|
BOP
Time Frame: 4.5months
|
bleeding on probing
|
4.5months
|
Micro-organisms concentration
Time Frame: 4.5months
|
DNA hybridization - checkerboard
|
4.5months
|
Micro-organisms concentration
Time Frame: 3months
|
DNA hybridization - checkerboard
|
3months
|
Concentration of inflammatory markers in crevicular fluid
Time Frame: 3months
|
Multiplex assay
|
3months
|
Concentration of inflammatory markers in crevicular fluid
Time Frame: 4.5 months
|
Multiplex assay
|
4.5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joao P Steffens, PhD, UFPR
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2017
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
June 1, 2017
First Submitted That Met QC Criteria
June 1, 2017
First Posted (Actual)
June 5, 2017
Study Record Updates
Last Update Posted (Actual)
April 16, 2020
Last Update Submitted That Met QC Criteria
April 14, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.906.729
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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