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

July 12, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Katholieke Universiteit Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Midazolam
Midazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment
Drug: Midazolam Mylan
Active Comparator: Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat

Lorazepam Mylan 2,5 mg tabletten 2.5mg Oral use Single dose 45 minutes before dental treatment

OR

Valium 10 mg/2 ml solution for injection 10mg Intramuscular use Single dose 45 minutes before dental treatment

+ Akineton 5 mg/ml solution for injection 5mg Intramuscular use Single dose 45 minutes before dental treatment

+ Dehydrobenzperidol 5 mg/2 ml solution for injection 0,000125 ml/cm2 Intramuscular use Single dose 45 minutes before dental treatment

+ Atropine sulfate Sterop 0,25mg/1ml solution for injection 0,25mg Intramuscular use Single dose 45 minutes before dental treatment
Drug: Lorazepam Mylan
Drug: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of cooperation of patient when receiving regular dental care
Time Frame: Participants will be followed for the duration of the dental treatment, an expected average of 30 minutes.
Participants will be followed for the duration of the dental treatment, an expected average of 30 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recording of vital parameters during regular dental care delivery
Time Frame: 24 hrs

The measure is a composite of

  • recording of blood pressure
  • recording of pulse
  • recording of oxygen saturation
24 hrs
Level of patient comfort and possible side-effects after dental treatment session
Time Frame: 24 hrs

The measure of patient comfort and possible side-effects after dental treatment session is a composite of

  • 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
24 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Dominique Declerck, KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimated)

March 5, 2014

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S55859
  • 2013-003991-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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