Dental Care for Disabled Clinical Trial
— OptiSeDentOfficial title:
Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability
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
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Katholieke Universiteit Leuven | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| Universitaire Ziekenhuizen Leuven |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Level of cooperation of patient when receiving regular dental care | Participants will be followed for the duration of the dental treatment, an expected average of 30 minutes. | No | |
| Secondary | 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 |
24 hrs | No |
| Secondary | 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 |
24 hrs | No |