UnknownPhase 4

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

Belgium40 participantsStarted 2013-12

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Level of cooperation of patient when receiving regular dental care

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

Trial details

NCT IDNCT02078336

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07

View on ClinicalTrials.gov More Dental Care for Disabled trials