Dental AnxietyPhase 3NCT01874717
Midazolam Sedation in Dentally Anxious Patients
A Phase 3 study testing Conscious sedation for dental care and midazolam in people with Dental Anxiety, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Use lay language. To compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route Read more about this study
- Who is it for?
- Ages 8 to 60 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Conscious sedation for dental care and midazolam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to Aug 2007
- Phase
- Phase 3
- 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 8 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- - Patient between 8 and 60 years, regardless of gender
- Patient in the American Society of Anesthesiologists (ASA) category I ou II.
- Patient in need of multiple dental care, referred to the Unit of Special Care Dentistry for cooperation difficulties
- Patients directed to conscious sedation under midazolam because they cannot be approached for more than a very brief examination, or following failure to treat under inhalation sedation (50% N2O/O2), or following poor cooperation during treatment under inhalation sedation (poor cooperation is defined as a score of 3 or more on the French modified version of the Venham scale), or following good cooperation during short and simple treatment under inhalation sedation but in need of more complex rehabilitation.
- Written consent signed by the patient or his legal guardian
- Patient accompanied by an accountable person
Who cannot join
- - Patient below 8 years or over 60 years-old
- Patient in the American Society of Anesthesiologists (ASA) category III or more
- Patient having accepted dental treatment without premedication or sedation, and without declaring dental anxiety, during the month prior to the appointment
- Patient having received an anxiolytic premedication in the 24 hours preceding the dental care session
- Patient already treated under midazolam sedation less than a week ago
- Any medical contraindication to the use of midazolam
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conscious Sedation With Midazolam in Dentally Anxious Patients: Effect of the Administration Route (Oral Versus Intravenous Administration)
Use lay language.
To compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route
Read the detailed description
The progress of the study is described below:
Session 1: intravenous administration of midazolam. Establishment of the individual dose.
Randomisation.
Session 2 :
Group A : oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.
Group B : intravenous administration of midazolam at the individual dose determined in session 1.
Session 3 : reversal of the procedures :
Group A : intravenous administration of midazolam at the individual dose determined in session 1.
Group B : oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.
- Conditions
- Dental Anxiety
- Being tested
- Conscious sedation for dental care, midazolam
- Keywords
- Conscious sedation, Dental anxiety, Oral midazolam, Intravenous midazolam, Behaviour
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conscious sedation for dental careOther
midazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| oral midazolam | Experimental | oral administration of midazolam : the dose administered is twice the individual dose determined in session 1. Receives: Other: Conscious sedation for dental care; Drug: midazolam |
| intravenous midazolam | Other | intravenous administration of midazolam at the individual dose determined in session 1 Receives: Other: Conscious sedation for dental care; Drug: midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient level of cooperation which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
Measured: At the first contact with the dentist (at day 1)
Patient level of cooperation which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from 0 to 5)
Measured: During venous cannulation (at day 1)
Patient level of cooperation which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
Measured: During the first injection of local anaesthesia (at day 1)
Patient level of cooperation which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
Measured: During the first dental care procedure (at day 1)
Secondary outcomes (5)
The level of patient stress which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
Measured: at T1 (first contact)
The level of patient stress which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
Measured: at T8 (end of dental treatment)
Satisfaction level of the patient which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from 0 to 5)
Measured: 48 hours after dental care (T14).
Satisfaction level of the accompanying person which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from 0 to 5)
Measured: 48 hours after dental care (T14).
Satisfaction level of the operator which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from 0 to 5)
Measured: 48 hours after dental care (T14).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJun 2005
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie COLLADO, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874717
- Sponsor's protocol ID
- CHU-0155
- Status last verified
- Jun 2013
- First submitted
- 28 May 2013
- Last updated
- 11 Jun 2013
- Results posted
- No
Publications
Collado V, Faulks D, Nicolas E, Hennequin M. Conscious sedation procedures using intravenous midazolam for dental care in patients with different cognitive profiles: a prospective study of effectiveness and safety. PLoS One. 2013 Aug 5;8(8):e71240. doi: 10.1371/journal.pone.0071240. Print 2013.
PubMed 23940729
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conscious Sedation With Midazolam in Dentally Anxious Patients: Effect of the Administration Route (Oral Versus Intravenous Administration)
- ClinicalTrials.gov ID
- NCT01874717
- Acronym / sponsor ID
- CHU-0155
- Conditions
- Dental Anxiety
- Keywords
- Conscious sedation, Dental anxiety, Oral midazolam, Intravenous midazolam, Behaviour
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 11 Jun 2013 (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.
Use lay language.
To compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route
Detailed description
The progress of the study is described below:
Session 1: intravenous administration of midazolam. Establishment of the individual dose.
Randomisation.
Session 2 :
Group A : oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.
Group B : intravenous administration of midazolam at the individual dose determined in session 1.
Session 3 : reversal of the procedures :
Group A : intravenous administration of midazolam at the individual dose determined in session 1.
Group B : oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral midazolam | Experimental | Other: Conscious sedation for dental care, Drug: midazolamoral administration of midazolam : the dose administered is twice the individual dose determined in session 1. |
| intravenous midazolam | Other | Other: Conscious sedation for dental care, Drug: midazolamintravenous administration of midazolam at the individual dose determined in session 1 |
Who may qualify
- Ages
- 8 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- - Patient between 8 and 60 years, regardless of gender
- Patient in the American Society of Anesthesiologists (ASA) category I ou II.
- Patient in need of multiple dental care, referred to the Unit of Special Care Dentistry for cooperation difficulties
- Patients directed to conscious sedation under midazolam because they cannot be approached for more than a very brief examination, or following failure to treat under inhalation sedation (50% N2O/O2), or following poor cooperation during treatment under inhalation sedation (poor cooperation is defined as a score of 3 or more on the French modified version of the Venham scale), or following good cooperation during short and simple treatment under inhalation sedation but in need of more complex rehabilitation.
- Written consent signed by the patient or his legal guardian
Key exclusion criteria (6 listed)
- - Patient below 8 years or over 60 years-old
- Patient in the American Society of Anesthesiologists (ASA) category III or more
- Patient having accepted dental treatment without premedication or sedation, and without declaring dental anxiety, during the month prior to the appointment
- Patient having received an anxiolytic premedication in the 24 hours preceding the dental care session
- Patient already treated under midazolam sedation less than a week ago
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 |
|---|---|---|
| Conscious sedation for dental care | Other | intravenous midazolam, oral midazolam |
| midazolam | Drug | intravenous midazolam, oral midazolam |
Primary outcome
Patient level of cooperation which is assessed using the French modified version of Venham scale
Time frame: At the first contact with the dentist (at day 1)
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
Patient level of cooperation which is assessed using the French modified version of Venham scale
Time frame: During venous cannulation (at day 1)
This scale offers a good description of behaviour and anxiety in one score (from 0 to 5)
Patient level of cooperation which is assessed using the French modified version of Venham scale
Time frame: During the first injection of local anaesthesia (at day 1)
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
Patient level of cooperation which is assessed using the French modified version of Venham scale
Time frame: During the first dental care procedure (at day 1)
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
5 secondary outcomes
The level of patient stress which is assessed using the French modified version of Venham scale
Time frame: at T1 (first contact)
The level of patient stress which is assessed using the French modified version of Venham scale
Time frame: at T8 (end of dental treatment)
Satisfaction level of the patient which is assessed using the French modified version of Venham scale
Time frame: 48 hours after dental care (T14).
Satisfaction level of the accompanying person which is assessed using the French modified version of Venham scale
Time frame: 48 hours after dental care (T14).
Satisfaction level of the operator which is assessed using the French modified version of Venham scale
Time frame: 48 hours after dental care (T14).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
- Derived from this study: PubMed 23940729Collado V, Faulks D, Nicolas E, Hennequin M. Conscious sedation procedures using intravenous midazolam for dental care in patients with different cognitive profiles: a prospective study of effectiveness and safety. PLoS One. 2013 Aug 5;8(8):e71240. doi: 10.1371/journal.pone.0071240. Print 2013.
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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.
Valérie COLLADO principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conscious sedation for dental care and midazolam in people with Dental Anxiety, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 11 Jun 2013. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient level of cooperation which is assessed using the French modified version of Venham scale (time frame: At the first contact with the dentist (at day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01874717, which also lists 1 linked publication.
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 11 Jun 2013.