Optimization of procedural sedation protocol used for dental care delivery in people with mental disability

Phase 1

• Conditions: imited cooperation of people with mental disability during regular dental care delivery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

• Registration Number: EUCTR2013-003991-11-BE
• Lead Sponsor: Katholieke Universiteit Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-07
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To assess the level of cooperation during regular dental care using different <br> procedural sedation protocols<br>- To assess patient safety during regular dental care using different sedation <br> protocols<br>- To assess patient comfort and possible side-effects after regular dental care <br> using different sedation protocols<br>;Secondary Objective: Not applicable;Primary end point(s): - level of cooperation of patient when receiving regular dental care;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated after the last visit of the last subject.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Recording of blood pressure, pulse, oxygen saturation during regular dental <br> care delivery<br>- Level of patient comfort and possible side-effects after dental treatment <br> session, including:<br> - changes in appetite<br> - changes in toilet behavior<br> - changes in level of consciousness<br> - changes in level of concentration<br> - changes in pattern of epileptic insults<br> - changes in mood <br> - changes in sleeping pattern<br> - changes in level of motor skills<br>;Timepoint(s) of evaluation of this end point: This endpoints will be evaluated after the last visit of the last subject.