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Periodontal health and response to non-surgical periodontal therapy in transgender individuals undergoing hormone therapy

Periodontal status and response to non-surgical periodontal therapy in transgender individuals undergoing hormone therapy: clinical, microbiological, and immunological assessment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-2skzsv2
Enrollment
Unknown
Registered
2026-01-15
Start date
2026-02-19
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transgender Persons

Interventions

This is a clinical, observational, prospective longitudinal study with two parallel groups, involving an estimated total of 60 participants, approximately 30 individuals using hormone therapy and 30 i

Sponsors

Faculdade de Odontologia - Universidade Federal de Uberlândia
Lead Sponsor
Universidade Federal de Uberlândia
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Participants eligible for inclusion will be individuals aged 18 to 60 years who identify as transgender men or transgender women. The case group will consist of participants undergoing hormone therapy, whereas the control group will include transgender individuals not receiving hormonal treatment. Groups will be age-matched within a ±3-year range. All participants must present a diagnosis of periodontitis in stages I, II, or III according to the criteria of Caton et al. (2018) and the 2021 American Academy of Periodontology classification, defined by clinical attachment loss affecting two or more non-adjacent interproximal sites or by clinical attachment loss of at least 3 mm on the buccal or lingual/palatal surfaces of at least two teeth. Only cases in which attachment loss is not attributable exclusively to traumatic gingival recession, cervical caries, distal attachment loss associated with third molar eruption, draining endodontic-periodontal lesions, or vertical root fractures will be considered eligible.

Exclusion criteria

Exclusion criteria: Participants will be excluded if they present loss of five or more teeth due to periodontitis, have used antibiotics within the previous six months, or have undergone non-surgical periodontal therapy during the same period. Individuals with systemic conditions that may influence periodontal disease progression or treatment response—such as diabetes or immunological disorders—will also be excluded, as well as those requiring antibiotic prophylaxis for routine dental procedures, those under prolonged use of anti-inflammatory medications, and pregnant individuals. Participants younger than 18 years of age or those who do not provide written informed consent will not be included.

Design outcomes

Primary

MeasureTime frame
To evaluate changes in periodontal probing depth between study baseline and 90 days after non-surgical periodontal therapy. Differences in these changes are expected between groups, particularly between individuals using and not using hormone therapy. The outcome will be assessed through clinical periodontal examination using a millimeter-calibrated periodontal probe. Changes in probing depth, expressed in millimeters, will be observed over time and between groups.

Secondary

MeasureTime frame
To evaluate changes in clinical attachment level between study baseline and 90 days after periodontal treatment. Differences in the magnitude of these changes are expected between individuals using and not using hormone therapy. The outcome will be assessed through clinical periodontal examination using a millimeter-calibrated periodontal probe. Changes in clinical attachment level, expressed in millimeters, will be observed across evaluation periods and between groups.;To evaluate the percentage reduction in bleeding on probing between study baseline and 90 days after the intervention. Differences between groups are expected, with lower values compared with baseline. The outcome will be assessed through clinical periodontal examination. Percentage changes in bleeding on probing will be observed across evaluation periods and between groups.;To evaluate quantitative changes in periodontopathogens at study baseline and at 30 and 90 days after the intervention. Reductions over time are expected, along with differences between groups at each time point. The outcome will be assessed through microbiological analysis using real-time polymerase chain reaction. Quantitative variations in periodontopathogenic microorganisms will be observed across time points and between groups.;To determine whether levels of inflammatory cytokines in gingival crevicular fluid or saliva change between study baseline and 90 days after the intervention. Temporal and within-group differences are expected. The outcome will be assessed through laboratory analyses for inflammatory cytokine quantification. Variations in cytokine levels will be observed across evaluation periods.;To evaluate changes in plaque index between study baseline and 90 days after the intervention. Reductions over time and differences between groups are expected. The outcome will be assessed through clinical examination using a standardized plaque index. Percentage changes in plaque index will be observed across evaluation pe

Countries

Brazil

Contacts

Public ContactPriscilla Soares

Faculdade de Odontologia - Universidade Federal de Uberlândia

pbfsoares@yahoo.com.br+55(34)3225-8106

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 7, 2026