Health-related quality of life in hospitalized patients with odontogenic infections – prospective multicenter observational study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039139

Enrollment

120

Registered

2026-01-27

Start date

2026-03-07

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

hospitalized odontogenic infection

Interventions

Group 1: Inpatients with odontogenic infections are asked to complete a questionnaire on health-related quality of life at the time of admission (T1), discharge (T2), and 3 months after inpatient trea

question about risk factors (smoking, alcohol, fear of dental treatment)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Inpatient admission due to odontogenic infection • Capable of giving consent and sufficient knowledge of German to answer questionnaires independently • Written consent to participate in the study • T1 assessment possible pre-op without immediately necessary emergency intervention (e.g., in case of impending airway obstruction) to delay further

Exclusion criteria

Exclusion criteria: • Age < 18 years • Incapable of giving consent (acute or permanent) • Non-odontogenic infection (e.g., trauma/tumor-associated without odontogenic focus) • Acute conditions that do not allow T1 assessment within the specified time frame • Readmissions: only one index stay per patient Note: Pregnant/breastfeeding women are not specifically excluded; no study-specific interventions are performed, only questionnaires and evaluation of pseudonymized routine data.

Design outcomes

Primary

Measure	Time frame
Change in overall health status between admission (T1) and discharge (T2), measured using EQ-VAS (?EQ-VAS).	—

Secondary

Measure	Time frame
• ?EQ-5D-5L index (T1?T2). H1: µ 1 0 (expected: >0, general health as measured by the EQ-5D-5L index improves during the inpatient stay, confirming the VAS observation and quantifying it on a preference basis). H0: µ(?EQ-5D-5L T1?T2) = 0 • ?Pain NRS (T1?T2). H1: µ 1 0 (expected: <0) Responder definition: Responder: ? = -2 or (NRS T1 – NRS T2)/NRS_T1 = 30% Pain decreases until discharge. H0: µ(?NRS T1?T2) = 0 • Long term (exploratory): ?OHIP-14 (T1?T3). H1: µ 1 0 (expected: <0, oral HRQoL improves over the follow-up period; the mean OHIP-14 is lower (=better) at T3 than at T1) H0: µ(?OHIP-14 T1?T3) = 0 • Norm comparison (descriptive): OHIP-14 at T1 and T3 vs. German reference values; proportion with OHIP “impact” • Feasibility/acceptance (descriptive): response/completion rates T1/T2/T3; reasons for non-participation. • Qualitative (T2): evaluation of the open-ended stress question (main topics/frequencies).• • Exploratory (predictors/centers): Associations of ? endpoints with age, gender, comorbidities/risk factors, extent, type of surgery/anesthesia, length of stay, complications, ICU, reoperation, antibiotic regimen including penicillin allergy label, and center (Koblenz/Mainz). Exploratory expectation: less favorable outcomes with higher disease burden/complications; possible center effects Statistical testing: All hypothesis tests are performed bilaterally with a = 0.05; the expected direction is stated in the literal H1 sentences.	—

Measure

Time frame

• ?EQ-5D-5L index (T1?T2). H1: µ 1 0 (expected: >0, general health as measured by the EQ-5D-5L index improves during the inpatient stay, confirming the VAS observation and quantifying it on a preference basis). H0: µ(?EQ-5D-5L T1?T2) = 0 • ?Pain NRS (T1?T2). H1: µ 1 0 (expected: <0) Responder definition: Responder: ? = -2 or (NRS T1 – NRS T2)/NRS_T1 = 30% Pain decreases until discharge. H0: µ(?NRS T1?T2) = 0 • Long term (exploratory): ?OHIP-14 (T1?T3). H1: µ 1 0 (expected: <0, oral HRQoL improves over the follow-up period; the mean OHIP-14 is lower (=better) at T3 than at T1) H0: µ(?OHIP-14 T1?T3) = 0 • Norm comparison (descriptive): OHIP-14 at T1 and T3 vs. German reference values; proportion with OHIP “impact” • Feasibility/acceptance (descriptive): response/completion rates T1/T2/T3; reasons for non-participation. • Qualitative (T2): evaluation of the open-ended stress question (main topics/frequencies).• • Exploratory (predictors/centers): Associations of ? endpoints with age, gender, comorbidities/risk factors, extent, type of surgery/anesthesia, length of stay, complications, ICU, reoperation, antibiotic regimen including penicillin allergy label, and center (Koblenz/Mainz). Exploratory expectation: less favorable outcomes with higher disease burden/complications; possible center effects Statistical testing: All hypothesis tests are performed bilaterally with a = 0.05; the expected direction is stated in the literal H1 sentences.

—

Countries

Germany

Contacts

Public ContactAndrea Schmid

Bundeswehrzentralkrankenhaus Koblenz

Andrea2Schmid@bundeswehr.org026128127870

Outcome results

None listed

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