Active — Not RecruitingPhase 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 range18 Years

SexALL

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

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