Dental AnaesthesiaNCT05193487
Intraosseous Anesthesia Versus Mandibular Nerve Block in Children
A study testing inferior alveolar nerve block and intra-osseous mandibular anaesthesia in people with Dental Anaesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the current study is to compare a new computerized intra-osseous injection system to the conventional inferior alveolar nerve block in children Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anaesthesia
- What is being tested?
- inferior alveolar nerve block and intra-osseous mandibular anaesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Nov 2021to 1 Nov 2022
- Phase
- Interventional
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aging between 6-9 years with no history of previous local dental anesthesia experience.
- American society of anesthesiologists score equal to or less than II
- Lower 2nd primary molars requiring pulpotomy
Who cannot join
- American society of anesthesiologists Score more than II
- Uncompliant, Uncooperative children
- Children turning non-compliant during procedure
- Patients taking analgesics and anti-inflammatory
- Un-restorable teeth, teeth near exfoliation, teeth with gingival abscess/fistula, pathological mobility, pain on percussion, radiographic evidence of internal or external pathological root resorption, periapical/furcation radio-lucencies, widened periodontal membrane space.
Trial locations and contacts
1 site in 1 country.
Mariem Wassel contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Ain Shams University
Cairo, 1156
Mohamed Diaa, Professor, 02 22639088, diaa67@dent.asu.edu.eg
About this study
Official title: Influence Of Computerized Intraosseous Anesthesia On Children's Behaviour In Comparison To Traditional Mandibular Nerve Block Technique: A Randomized Clinical Trial
The aim of the current study is to compare a new computerized intra-osseous injection system to the conventional inferior alveolar nerve block in children
Read the detailed description
Patients will be randomly allocated to one of the experimental groups.: Conventional (Inferior alveolar nerve block) and Computerized intraosseous anesthesia administration using the Quick Sleeper 5TM system (Dental Hi TecTM, Cholet, France). Both techniques will be performed by a single trained operator.
Articaine 4% with 1/200000 Adrenaline will be used for both techniques.
- Conditions
- Dental Anaesthesia
- Being tested
- inferior alveolar nerve block, intra-osseous mandibular anaesthesia
- Keywords
- intra-osseous anesthesia, inferior alveolar nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inferior alveolar nerve blockOther
inferior alveolar nerve block using Articaine 4% with 1/200000 Adrenaline and a traditional needle injection
intra-osseous mandibular anaesthesiaOther
intra-osseous mandibular anaesthesia using Articaine 4% with 1/200000 Adrenaline and a special intra-osseous injection device
| Study group | Role | What they receive |
|---|---|---|
| inferior alveolar nerve block | Active comparator | Conventional inferior alvoelar nerve block anaesthesia will be given using a traditional metal syringe Receives: Other: inferior alveolar nerve block |
| intra-osseous mandibular anaesthesia | Experimental | Computerized intraosseous anesthesia administration using the Quick Sleeper 5TM system (Dental Hi TecTM, Cholet, France) Receives: Other: intra-osseous mandibular anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's level of cooperation
The child behavior will be evaluated using the modified Venham scale (scores 0-5) where higher scores indicate uncooperative behavior
Measured: directly after anesthetic injection while providing the dental treatment
Secondary outcomes (2)
Heart Rate
Heart Rate (physiological measure)
Measured: before injection, during injection and directly after injection.
Anesthesia success or failure
Completing the needed treatment will be recorded as anesthesia success while failure to complete pulpotomy due to pain will be recorded as anesthesia failure
Measured: directly after anesthetic injection while providing the dental treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start4 Nov 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
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 AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariem Wassel, Ain Shams University
- Investigators
- Mohamed Zayed, lecturer, Principal investigator, Faculty of Dentistry, Ain Shams University, Cairo, Eypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193487
- Sponsor's protocol ID
- FDASU-Rec R102110
- Status last verified
- Jan 2022
- First submitted
- 8 Dec 2021
- Last updated
- 31 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radwan MZ, Wassel MO, El Geleel OA, Elghazawy RK. Influence of computerized intraosseous anesthesia compared with traditional mandibular nerve block on children's behavior: A randomized clinical trial. Int J Paediatr Dent. 2025 Mar;35(2):281-288. doi: 10.1111/ipd.13231. Epub 2024 Jun 24.
PubMed 38923102
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence Of Computerized Intraosseous Anesthesia On Children's Behaviour In Comparison To Traditional Mandibular Nerve Block Technique: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05193487
- Acronym / sponsor ID
- FDASU-Rec R102110
- Conditions
- Dental Anaesthesia
- Keywords
- intra-osseous anesthesia, inferior alveolar nerve block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 18 Jan 2022 (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.
The aim of the current study is to compare a new computerized intra-osseous injection system to the conventional inferior alveolar nerve block in children
Detailed description
Patients will be randomly allocated to one of the experimental groups.: Conventional (Inferior alveolar nerve block) and Computerized intraosseous anesthesia administration using the Quick Sleeper 5TM system (Dental Hi TecTM, Cholet, France). Both techniques will be performed by a single trained operator.
Articaine 4% with 1/200000 Adrenaline will be used for both techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inferior alveolar nerve block | Active comparator | Other: inferior alveolar nerve blockConventional inferior alvoelar nerve block anaesthesia will be given using a traditional metal syringe |
| intra-osseous mandibular anaesthesia | Experimental | Other: intra-osseous mandibular anaesthesiaComputerized intraosseous anesthesia administration using the Quick Sleeper 5TM system (Dental Hi TecTM, Cholet, France) |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aging between 6-9 years with no history of previous local dental anesthesia experience.
- American society of anesthesiologists score equal to or less than II
- Lower 2nd primary molars requiring pulpotomy
Key exclusion criteria (5 listed)
- American society of anesthesiologists Score more than II
- Uncompliant, Uncooperative children
- Children turning non-compliant during procedure
- Patients taking analgesics and anti-inflammatory
- Un-restorable teeth, teeth near exfoliation, teeth with gingival abscess/fistula, pathological mobility, pain on percussion, radiographic evidence of internal or external pathological root resorption, periapical/furcation radio-lucencies, widened periodontal membrane space.
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 |
|---|---|---|
| inferior alveolar nerve blockinferior alveolar nerve block using Articaine 4% with 1/200000 Adrenaline and a traditional needle injection | Other | inferior alveolar nerve block |
| intra-osseous mandibular anaesthesiaintra-osseous mandibular anaesthesia using Articaine 4% with 1/200000 Adrenaline and a special intra-osseous injection device | Other | intra-osseous mandibular anaesthesia |
Primary outcome
Patient's level of cooperation
Time frame: directly after anesthetic injection while providing the dental treatment
The child behavior will be evaluated using the modified Venham scale (scores 0-5) where higher scores indicate uncooperative behavior
2 secondary outcomes
Heart Rate
Time frame: before injection, during injection and directly after injection.
Anesthesia success or failure
Time frame: directly after anesthetic injection while providing the dental treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Derived from this study: PubMed 38923102Radwan MZ, Wassel MO, El Geleel OA, Elghazawy RK. Influence of computerized intraosseous anesthesia compared with traditional mandibular nerve block on children's behavior: A randomized clinical trial. Int J Paediatr Dent. 2025 Mar;35(2):281-288. doi: 10.1111/ipd.13231. Epub 2024 Jun 24.
- Individual participant dataSharing planned: No
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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.
Mariem Wassel contact
Mohamed Zayed, lecturer principal investigator
Faculty of Dentistry, Ain Shams University, Cairo, Eypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inferior alveolar nerve block and intra-osseous mandibular anaesthesia in people with Dental Anaesthesia, run by Ain Shams University 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 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 31 Jan 2022. 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.
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?
Contact Mohamed Zayed, lecturer (+20 01111480002, mradwan@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's level of cooperation (time frame: directly after anesthetic injection while providing the dental treatment). 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 NCT05193487, 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 31 Jan 2022.