Exploratory study on changes in oral clinical parameters during the first 24 months of gender transition

Exploratory study on changes in oral clinical parameters during the first 24 months of gender transition - TransOral

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039617

Enrollment

Registered

2026-03-13

Start date

2026-03-13

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

F64.0

Interventions

Group 1: Investigation of changes in oral clinical parameters during gender-affirming hormone therapy with testosterone in individuals undergoing a female-to-male transition. Clinical examinations (or

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Arm 1/2: Participants scheduled to receive gender-affirming hormone therapy, periodontally healthy. Arm 3/4: Cisgender women (control group for trans female-to-male group) or cisgender men (control group for trans male-to-female group), age- and sex-matched to the experimental group, periodontally healthy, not receiving hormone therapy (including hormonal contraceptives)

Exclusion criteria

Exclusion criteria: minors, smokers, use of medications that may affect periodontal health or healing (e.g., anticoagulants, drugs that may cause gingival hyperplasia such as immunosuppressants, calcium channel blockers, antiepileptics, as well as antiresorptive agents), diabetes mellitus, obesity (BMI =30), other oral mucosal diseases (e.g., lichenoid conditions), use of hormonal contraceptives, pregnancy, breastfeeding, active orthodontic treatment, and use of chlorhexidine-containing mouthwash within the last 4 weeks

Design outcomes

Primary

Measure	Time frame
Gingival inflammation (T0–T6): Papillary bleeding index according to Saxer and Mühlemann 1975 (PBI), periodontal status (probing depths [PD], recessions [REC], clinical attachment level [CAL], bleeding on probing according to Ainamo and Bay 1975 [BOP]), periodontal inflamed surface area according to Nesse et al. 2008 (PISA). Hormone levels of estrogen/testosterone in serum (T0–T6)	—

Secondary

Measure	Time frame
Plaque index according to Silness and Löe 1963 (PI) DMFT index, sum of decayed, missing, and filled teeth (Klein/Palmer 1938) OHIP-G-5 score (questionnaire on oral health-related quality of life) Patient-centered outcomes (study-specific questionnaire) Blood pressure Pulse Body weight / height / BMI Blood parameters: creatinine, cholesterol, triglycerides, LDL, HDL, AST (GOT), ALT (GPT), estradiol, testosterone, sex hormone-binding globulin (SHBG), proBNP, creatine kinase, complete blood count Microbiological parameters: oral microbiota from saliva and supragingival plaque samples	—

Measure

Time frame

Plaque index according to Silness and Löe 1963 (PI) DMFT index, sum of decayed, missing, and filled teeth (Klein/Palmer 1938) OHIP-G-5 score (questionnaire on oral health-related quality of life) Patient-centered outcomes (study-specific questionnaire) Blood pressure Pulse Body weight / height / BMI Blood parameters: creatinine, cholesterol, triglycerides, LDL, HDL, AST (GOT), ALT (GPT), estradiol, testosterone, sex hormone-binding globulin (SHBG), proBNP, creatine kinase, complete blood count Microbiological parameters: oral microbiota from saliva and supragingival plaque samples

—

Countries

Germany

Contacts

Public ContactAnne Kruse

Klinik für Zahnerhaltungskunde und Parodontologie, Universitätsklinikum Freiburg

anne.kruse@uniklinik-freiburg.de+47 761 270 47310

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026