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

Phase 4Active Not RecruitingNCT02078336

Universitaire Ziekenhuizen KU Leuven40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Dental Care for Disabled

Interventions

Midazolam Mylan

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Minimum age 18yrs * Patient resides at least 6 months in nursing home "het Gielsbos". * Patient always gets a sedative protocol to make dental care delivery possible. * Informed consent was obtained from parent/guardian * No medical contra-indication for any of tested sedative protocols Exclusion Criteria: * Age under 18yrs * The patient is no resident of the nursing home "het Gielsbos" or lives there for less than 6 months. * No need for medicinal support during dental treatment * No informed consent was obtained by parents or the guardian of the patient. * Medical contra-indication for 1 of the sedative protocols

Outcomes

Primary Outcomes

Level of cooperation of patient when receiving regular dental care

Time frame: Participants will be followed for the duration of the dental treatment, an expected average of 30 minutes.

Secondary Outcomes

Recording of vital parameters during regular dental care delivery

The measure is a composite of * recording of blood pressure * recording of pulse * recording of oxygen saturation

Time frame: 24 hrs

Level of patient comfort and possible side-effects after dental treatment session

The measure of patient comfort and possible side-effects after dental treatment session is a composite of * changes in appetite * changes in toilet behavior * changes in level of consciousness * changes in level of concentration * changes in pattern of epileptic insults * changes in mood * changes in sleeping pattern * changes in level of motor skills