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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003991-11-BE

Enrollment

Registered

2013-10-07

Start date

2013-12-03

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limited cooperation of people with mental disability during regular dental care delivery

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: - 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 ;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.	—

Measure

Time frame

Main Objective: - 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 ;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.

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Secondary

Measure	Time frame
Secondary end point(s): - Recording of blood pressure, pulse, oxygen saturation during regular dental care delivery - Level of patient comfort and possible side-effects after dental treatment session, including: - 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 ;Timepoint(s) of evaluation of this end point: This endpoints will be evaluated after the last visit of the last subject.	—

Measure

Time frame

Secondary end point(s): - Recording of blood pressure, pulse, oxygen saturation during regular dental care delivery - Level of patient comfort and possible side-effects after dental treatment session, including: - 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 ;Timepoint(s) of evaluation of this end point: This endpoints will be evaluated after the last visit of the last subject.

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Countries

Belgium

Contacts

Public Contactprofessor Dominique Declerck

Katholieke Universiteit Leuven

dominique.declerck@med.kuleuven.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026