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ACTIVE NOT RECRUITING
NCT02078336
PHASE4

Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

The study aims to compare procedural sedation protocols, specifically applied for the delivery of regular dental care in persons with a mental disability. The primary objectives are: * To assess the level of cooperation during regular dental care using different procedural sedation protocols * To assess patient safety during regular dental care using different sedation protocols * To assess patient comfort and possible side-effects after regular dental care using different sedation protocols

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2013-12

Completion Date

2025-07

Last Updated

2024-07-16

Healthy Volunteers

No

Interventions

DRUG

Midazolam Mylan

DRUG

Lorazepam Mylan

DRUG

Valium + Akineton + Dehydrobenzperidol + Atropine sulfate

Locations (1)

Katholieke Universiteit Leuven

Leuven, Belgium