An interventional study of dental syringe ( NumBee) and Traditional dental syringe in Dental Phobia, Dental Anxiety and Anesthesia, Local, sponsored by Duaa Kamal Naji. Completed at 1 site in Iraq. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by Duaa Kamal Naji · Not applicable, Interventional, and Device feasibility
The study was conducted among a group of dental patients aged (6-8 years old) of both genders to assess the following variables in the needleless interparliamentary anesthesia (NUMBEE) compared to traditional local anesthesia:
The prevalent phobia of needles and the associated rise in dental anxiety when using the traditional needle method of LA infiltration, the development of needle-free alternatives for local anesthetics became an urgent necessity. The NumBee (BioDent, Simi Valley, CA) is a new gadget that promises less pain administration of local anesthetic without the use of a hypodermic needle. It is a tiny metal cannula with a silicone-like covering that is used for intraligmentary injection without penetrating the periodontal ligament. This study was performed due to the lack of sufficient research on NumBee and since it meets a number of exceptional criteria, including being able to anesthetize just one tooth without having to do so for the entire alveolar dental nerve and having a needleless design that may be more appealing to children than the distressing appearance of traditional dental syringes.
84 studies on the registry are indexed under Phobic Disorders; 15 are open to participants now.
This study's enrollment of 30 is below the median of 66 across 69 interventional studies indexed under Phobic Disorders.
Browse Phobic Disorders studies →This is the only study on the registry with Duaa Kamal Naji as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:1. Patients with -1(ASA 1) health status (A completely healthy fit patient).
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dental anesthesia delivered by a traditional syringe
Device: Traditional dental syringe
Dental anesthesia delivered by a novel needle-less syringe
Device: dental syringe ( NumBee)
assess the capability of NumBee to reduce anxiety and pain during injection
compare the level of anxiety of the traditional dental syringe and the Number dental syringe
pain perception
checking the efficacy of NumBee syringe in reducing pain and anxiety in dental treatment
Time frame: five months
Plan to share: Yes — it will be my pleasure to share and information with other resaercher
Supporting information: Study protocol
Time frame: it will be available in 2023/2024 and for no limits
Access criteria: data will be sent in e-mail for anyone wishes to access. Doaa.Kamal1202a@codental.uobaghdad.edu.iq
No publications or documents are linked to this record.
Ran from Mar 2022 to primary completion in Aug 2022, 4 months.
Of 28 interventional studies with no phase under Phobic Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 44. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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