Dental AnxietyPhase 2NCT04608734
Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Patients
A Phase 2 study testing Buccal midazolam and Intranasal midazolam in people with Dental Anxiety, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Buccal midazolam and Intranasal midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2015to 25 Jun 2016
- Phase
- Phase 2
- 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Negative and definitely negative behavior according Frankl's scale.
- ASA Group I (normal healthy patient without systemic disease) and II (patient with mild systemic disease) with no medical contraindication which rules out the use of midazolam.
- Children with at least two carious lesions requiring dental intervention in two settings of not more than 30 minute each.
Who cannot join
- Children with multiple carious lesions who require treatment under general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Dental Patients
Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment.
Read the detailed description
Thirty six children fulfilling the requirements of having a dental condition that needed treatment in two dental settings, not exceeding thirty minutes each. They were randomly assigned to one of two groups, according to the treatment offered at the first visit. At the first visit, either buccal or intranasal aerosolized midazolam was administered. At the second visit the alternate route was implemented in a cross-over design with a one week washout period. Vital signs were recorded at baseline and at 5 minutes interval throughout the treatment session.
- Conditions
- Dental Anxiety
- Being tested
- Buccal midazolam, Intranasal midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal midazolamDrug
The drug was sprayed in the buccal vestibule across the area between the primary first and second molars in all four quadrants to maximize the absorption through wide area of the buccal mucosa.
Intranasal midazolamDrug
Half of the dose was sprayed in the right nostril and the other half in the left nostril to double the absorptive surface area by short and quick puffs.
| Study group | Role | What they receive |
|---|---|---|
| Buccal midazolam | Experimental | Not described Receives: Drug: Buccal midazolam |
| Intranasal midazolam | Active comparator | Not described Receives: Drug: Intranasal midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of drug administration
Assessed by a 3 point Likert scale as follows: (1) the child accepted the drug readily. 2 (fair) the child accepted the drug with some resistance. 3 (poor) the child accepted the drug with great resistance. 4 (refused) the child refused but drug administration was possible after persuasion.
Measured: during the sedation procedure
Sleep score
This will be assessed using modified Houpt scale for behavior rating:
- Awake, alert.
- Drowsy, disoriented.
- Intermittently asleep.
- Sound asleep.
Measured: after 5 minutes
Crying score
This will be assessed using modified Houpt scale for behavior rating:
- Hysterical, demands attention.
- Continuous, making treatment difficult.
- Intermittent, mild, does not interfere with treatment.
- No crying present.
Measured: after 5 minutes
Head/oral resistance score
This will be assessed using modified Houpt scale for behavior rating:
- Turns head, refuses to open mouth.
- Mouth closing, must request to open.
- Chocking, gagging, spitting.
- No head/oral resistance present.
Measured: after 5 minutes
Overall behavior
This will be assessed using modified Houpt scale for behavior rating:
- Aborted, no treatment performed.
- Very poor, treatment interrupted, partial treatment completed.
- Fair, difficult, all treatment completed.
- Good, some limited crying or movement.
- Excellent, no crying or movement.
Measured: immediately after completion of the dental treatment procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start10 Jun 2015
- Primary completion13 Jun 2016
- Study completion25 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Yousr N Mowafy, M.Sc, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptNadia A Wahba, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptTamer M Ghoneim, PhD, Study chair, Faculty of Medicine, Alexandria University, EgyptGhada M Mahmoud, PhD, Study chair, Faculty of Dentistry, University of Modern Sciences and Arts, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608734
- Sponsor's protocol ID
- Buccal vs intranasal midazolam
- Status last verified
- Oct 2020
- First submitted
- 24 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chopra R, Marwaha M. Assessment of buccal aerosolized midazolam for pediatric conscious sedation. J Investig Clin Dent. 2015 Feb;6(1):40-4. doi: 10.1111/jicd.12062. Epub 2013 Dec 20.
PubMed 24357534al-Rakaf H, Bello LL, Turkustani A, Adenubi JO. Intra-nasal midazolam in conscious sedation of young paediatric dental patients. Int J Paediatr Dent. 2001 Jan;11(1):33-40. doi: 10.1046/j.1365-263x.2001.00237.x.
PubMed 11309871Kupietzky A, Houpt MI. Midazolam: a review of its use for conscious sedation of children. Pediatr Dent. 1993 Jul-Aug;15(4):237-41. No abstract available.
PubMed 8247896Kupietzky A, Holan G, Shapira J. Intranasal midazolam better at effecting amnesia after sedation than oral hydroxyzine: a pilot study. Pediatr Dent. 1996 Jan-Feb;18(1):32-4.
PubMed 8668567Primosch RE, Guelmann M. Comparison of drops versus spray administration of intranasal midazolam in two- and three-year-old children for dental sedation. Pediatr Dent. 2005 Sep-Oct;27(5):401-8.
PubMed 16435641Houpt MI, Weiss NJ, Koenigsberg SR, Desjardins PJ. Comparison of chloral hydrate with and without promethazine in the sedation of young children. Pediatr Dent. 1985 Mar;7(1):41-6. No abstract available.
PubMed 3857559
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Dental Patients
- ClinicalTrials.gov ID
- NCT04608734
- Acronym / sponsor ID
- Buccal vs intranasal midazolam
- Conditions
- Dental Anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- 13 Jun 2016 (actual)
- Study completion
- 25 Jun 2016 (actual)
- First posted
- 29 Oct 2020 (actual)
- 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.
Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment.
Detailed description
Thirty six children fulfilling the requirements of having a dental condition that needed treatment in two dental settings, not exceeding thirty minutes each. They were randomly assigned to one of two groups, according to the treatment offered at the first visit. At the first visit, either buccal or intranasal aerosolized midazolam was administered. At the second visit the alternate route was implemented in a cross-over design with a one week washout period. Vital signs were recorded at baseline and at 5 minutes interval throughout the treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccal midazolam | Experimental | Drug: Buccal midazolam |
| Intranasal midazolam | Active comparator | Drug: Intranasal midazolam |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Negative and definitely negative behavior according Frankl's scale.
- ASA Group I (normal healthy patient without systemic disease) and II (patient with mild systemic disease) with no medical contraindication which rules out the use of midazolam.
- Children with at least two carious lesions requiring dental intervention in two settings of not more than 30 minute each.
Key exclusion criteria (1 listed)
- Children with multiple carious lesions who require treatment under general anesthesia.
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 |
|---|---|---|
| Buccal midazolamThe drug was sprayed in the buccal vestibule across the area between the primary first and second molars in all four quadrants to maximize the absorption through wide area of the buccal mucosa. | Drug | Buccal midazolam |
| Intranasal midazolamHalf of the dose was sprayed in the right nostril and the other half in the left nostril to double the absorptive surface area by short and quick puffs. | Drug | Intranasal midazolam |
Primary outcome
Acceptance of drug administration
Time frame: during the sedation procedure
Assessed by a 3 point Likert scale as follows: (1) the child accepted the drug readily. 2 (fair) the child accepted the drug with some resistance. 3 (poor) the child accepted the drug with great resistance. 4 (refused) the child refused but drug administration was possible after persuasion.
Sleep score
Time frame: after 5 minutes
This will be assessed using modified Houpt scale for behavior rating: 1. Awake, alert. 2. Drowsy, disoriented. 3. Intermittently asleep. 4. Sound asleep.
Crying score
Time frame: after 5 minutes
This will be assessed using modified Houpt scale for behavior rating: 1. Hysterical, demands attention. 2. Continuous, making treatment difficult. 3. Intermittent, mild, does not interfere with treatment. 4. No crying present.
Head/oral resistance score
Time frame: after 5 minutes
This will be assessed using modified Houpt scale for behavior rating: 1. Turns head, refuses to open mouth. 2. Mouth closing, must request to open. 3. Chocking, gagging, spitting. 4. No head/oral resistance present.
Overall behavior
Time frame: immediately after completion of the dental treatment procedures
This will be assessed using modified Houpt scale for behavior rating: 1. Aborted, no treatment performed. 2. Very poor, treatment interrupted, partial treatment completed. 3. Fair, difficult, all treatment completed. 4. Good, some limited crying or movement. 5. Excellent, no crying or movement.
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 29 Oct 2020.
- Background: PubMed 24357534Chopra R, Marwaha M. Assessment of buccal aerosolized midazolam for pediatric conscious sedation. J Investig Clin Dent. 2015 Feb;6(1):40-4. doi: 10.1111/jicd.12062. Epub 2013 Dec 20.
- Background: PubMed 11309871al-Rakaf H, Bello LL, Turkustani A, Adenubi JO. Intra-nasal midazolam in conscious sedation of young paediatric dental patients. Int J Paediatr Dent. 2001 Jan;11(1):33-40. doi: 10.1046/j.1365-263x.2001.00237.x.
- Background: PubMed 8247896Kupietzky A, Houpt MI. Midazolam: a review of its use for conscious sedation of children. Pediatr Dent. 1993 Jul-Aug;15(4):237-41. No abstract available.
- Background: PubMed 8668567Kupietzky A, Holan G, Shapira J. Intranasal midazolam better at effecting amnesia after sedation than oral hydroxyzine: a pilot study. Pediatr Dent. 1996 Jan-Feb;18(1):32-4.
- Background: PubMed 16435641Primosch RE, Guelmann M. Comparison of drops versus spray administration of intranasal midazolam in two- and three-year-old children for dental sedation. Pediatr Dent. 2005 Sep-Oct;27(5):401-8.
- Background: PubMed 3857559Houpt MI, Weiss NJ, Koenigsberg SR, Desjardins PJ. Comparison of chloral hydrate with and without promethazine in the sedation of young children. Pediatr Dent. 1985 Mar;7(1):41-6. No abstract available.
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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.
Yousr N Mowafy, M.Sc principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Nadia A Wahba, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
Tamer M Ghoneim, PhD study chair
Faculty of Medicine, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buccal midazolam and Intranasal midazolam in people with Dental Anxiety, run by Nourhan M.Aly at 1 site in Egypt.
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 3 inclusion and 1 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 29 Oct 2020. 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Acceptance of drug administration (time frame: during the sedation procedure). The study lists 5 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 NCT04608734, which also lists 6 linked publications.
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 29 Oct 2020.