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

Information source: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dental Care for Disabled

Intervention: Midazolam Mylan (Drug); Lorazepam Mylan (Drug); Valium + Akineton + Dehydrobenzperidol + Atropine sulfate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Universitaire Ziekenhuizen Leuven

Official(s) and/or principal investigator(s):
Dominique Declerck, Principal Investigator, Affiliation: Katholieke Universiteit Leuven

Overall contact:
Dominique Declerck, Email: dominique.declerck@med.kuleuven.be

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Level of cooperation of patient when receiving regular dental care

Secondary outcome:

Recording of vital parameters during regular dental care delivery

Level of patient comfort and possible side-effects after dental treatment session

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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

Locations and Contacts

Dominique Declerck, Email: dominique.declerck@med.kuleuven.be

Katholieke Universiteit Leuven, Leuven 3000, Belgium; Recruiting
Dominique Declerck, Email: dominique.declerck@med.kuleuven.be
Ine Opsomer, Email: ine.opsomer@uzleuven.be
Additional Information

Starting date: December 2013
Last updated: February 28, 2014

Page last updated: August 23, 2015

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