Validation of lateral cephalometric radiography (LCR) in upright position as a predictor of the expected somnological outcome of mandibular advancement device (MAD) therapy – a retrospective study

Validation of lateral cephalometric radiography (LCR) in upright position as a predictor of the expected somnological outcome of mandibular advancement device (MAD) therapy – a retrospective study - FRS MAD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040097

Enrollment

Registered

2026-04-27

Start date

2026-05-04

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

G47.31

Interventions

Group 1: Retrospective cohort of patients diagnosed with obstructive sleep apnea (OSA) treated with a mandibular advancement device (MAD). No intervention is performed ?????? the study

routine clinical data and lateral cephalometric radiographs (LCR) in retruded mandibular position and therapeutic start protrusion are analyzed.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosed obstructive sleep apnea (OSA) Treatment with a mandibular advancement device (MAD) Availability of complete clinical routine data (including polysomnography/polygraphy before and after therapy) Availability of lateral cephalometric radiographs (LCR) in retruded mandibular position and therapeutic start protrusion

Exclusion criteria

Exclusion criteria: Incomplete or missing clinical data (e.g., missing PSG/PG follow-up data) Missing or non-evaluable lateral cephalometric radiographs (LCR) Previous surgical interventions in the upper airway or craniofacial region Severe craniofacial anomalies or malformations Insufficient mandibular protrusion capacity (< 5 mm) Severe comorbidities affecting respiration or sleep architecture

Design outcomes

Primary

Measure	Time frame
Association between changes in posterior airway space (SPAS, MAS, IAS) in lateral cephalometric radiographs and treatment success, measured by reduction in the apnea-hypopnea index (AHI). WHAT: Change in apnea-hypopnea index (AHI) as a measure of treatment success and its association with changes in posterior airway space (SPAS, MAS, IAS). WHEN: Baseline: prior to initiation of mandibular advancement device therapy (baseline polysomnography/polygraphy) Follow-up: after completion of titration of the mandibular advancement device during follow-up polysomnography/polygraphy HOW: AHI is assessed using standardized polysomnography (PSG) or polygraphy (PG). Posterior airway space (SPAS, MAS, IAS) is measured using lateral cephalometric radiographs (LCR) in retruded mandibular position (baseline) and therapeutic start protrusion. Radiographic analysis is performed using dedicated software (OnyxCeph, Image Instruments, Chemnitz, Germany) based on predefined cephalometric landmarks.	—

Measure

Time frame

Association between changes in posterior airway space (SPAS, MAS, IAS) in lateral cephalometric radiographs and treatment success, measured by reduction in the apnea-hypopnea index (AHI). WHAT: Change in apnea-hypopnea index (AHI) as a measure of treatment success and its association with changes in posterior airway space (SPAS, MAS, IAS). WHEN: Baseline: prior to initiation of mandibular advancement device therapy (baseline polysomnography/polygraphy) Follow-up: after completion of titration of the mandibular advancement device during follow-up polysomnography/polygraphy HOW: AHI is assessed using standardized polysomnography (PSG) or polygraphy (PG). Posterior airway space (SPAS, MAS, IAS) is measured using lateral cephalometric radiographs (LCR) in retruded mandibular position (baseline) and therapeutic start protrusion. Radiographic analysis is performed using dedicated software (OnyxCeph, Image Instruments, Chemnitz, Germany) based on predefined cephalometric landmarks.

—

Secondary

Measure	Time frame
Change in oxygen desaturation index (ODI) Association between degree of mandibular protrusion and change in posterior airway space Influence of demographic factors (age, sex, BMI) on treatment outcome	—

Countries

Germany

Contacts

Public ContactSabine Linsen

Universität Bonn, UKB

sabine.linsen@ukbonn.de+4922828722436

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026