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

NCT02078336 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-16

No results posted yet for this study

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

Conditions

  • Dental Care for Disabled

Interventions

DRUG

Midazolam Mylan

DRUG

Lorazepam Mylan

DRUG

Valium + Akineton + Dehydrobenzperidol + Atropine sulfate

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Dominique Declerck · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02078336 on ClinicalTrials.gov