Dental Care for DisabledPhase 4OptiSeDentNCT02078336
Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability
A Phase 4 study testing Midazolam Mylan, Lorazepam Mylan and Valium + Akineton + Dehydrobenzperidol + Atropine sulfate in people with Dental Care for Disabled, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Care for Disabled
- What is being tested?
- Midazolam Mylan, Lorazepam Mylan and Valium + Akineton + Dehydrobenzperidol + Atropine sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2013to Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Dental Care for Disabled
- Being tested
- Midazolam Mylan, Lorazepam Mylan, Valium + Akineton + Dehydrobenzperidol + Atropine sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam MylanDrug
Lorazepam MylanDrug
Valium + Akineton + Dehydrobenzperidol + Atropine sulfateDrug
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Experimental | Midazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment Receives: Drug: Midazolam Mylan |
| Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat | Active comparator | 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 Receives: Drug: Lorazepam Mylan; Drug: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of cooperation of patient when receiving regular dental care
Measured: Participants will be followed for the duration of the dental treatment, an expected average of 30 minutes.
Secondary outcomes (2)
Recording of vital parameters during regular dental care delivery
The measure is a composite of
- recording of blood pressure
- recording of pulse
- recording of oxygen saturation
Measured: 24 hrs
Level of patient comfort and possible side-effects after dental treatment session
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
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Care for DisabledStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Declerck, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078336
- Sponsor's protocol ID
- S55859
- Other IDs
- 2013-003991-11
- Acronym
- OptiSeDent
- Status last verified
- Jul 2024
- First submitted
- 24 Feb 2014
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability
- ClinicalTrials.gov ID
- NCT02078336
- Acronym / sponsor ID
- OptiSeDent / S55859
- Conditions
- Dental Care for Disabled
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Experimental | Drug: Midazolam MylanMidazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment |
| Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat | Active comparator | Drug: Lorazepam Mylan, Drug: Valium + Akineton + Dehydrobenzperidol + Atropine sulfateLorazepam 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam Mylan | Drug | Midazolam |
| Lorazepam Mylan | Drug | Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat |
| Valium + Akineton + Dehydrobenzperidol + Atropine sulfate | Drug | Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat |
Primary outcome
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.
2 secondary outcomes
Recording of vital parameters during regular dental care delivery
Time frame: 24 hrs
Level of patient comfort and possible side-effects after dental treatment session
Time frame: 24 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Declerck principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam Mylan, Lorazepam Mylan and Valium + Akineton + Dehydrobenzperidol + Atropine sulfate in people with Dental Care for Disabled, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.