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Clinical Trials/EUCTR2013-003991-11-BE
EUCTR2013-003991-11-BE
Active, Not Recruiting
Phase 1

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

Katholieke Universiteit Leuven0 sites40 target enrollmentOctober 7, 2013
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Conditionsimited cooperation of people with mental disability during regular dental care deliveryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
DrugsMidazolam Mylan 5 mg/ml oplossing voor injectieLorazepam Mylan 2,5 mg tablettenValium 10 mg/2 ml oplossing voor injectieAkineton, injectie 5 mg/mlDehydrobenzperidol 5 mg/2 ml oplossing voor injectieAtropine sulfate Sterop 0,25mg/1ml, oplossing voor injectie

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
imited cooperation of people with mental disability during regular dental care delivery
Sponsor
Katholieke Universiteit Leuven
Enrollment
40
Status
Active, Not Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 7, 2013
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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