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OpenTrials
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NCT Number: NCT02078336

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Dental Care for Disabled

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midazolam Mylan

Drug

Lorazepam Mylan

Drug

Valium + Akineton + Dehydrobenzperidol + Atropine sulfate

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: OptiSeDent

Important dates

Study start
2013
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2014
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.