Buzzy System Compared to Topical Anaesthesia During Infiltration Injection in Children.
NCT ID: NCT05083975
Last Updated: 2024-03-21
Study Results
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Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2022-07-23
2023-05-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Buzzy System
Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after activating the buzzy device extra orally proximal to the site of injection for 30-60 seconds.
Buzzy System
Vibrating Device
1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000
Local dental anesthetic agent
Control
Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after application of 20% Benzocaine topical anesthestic gel.
Topical anesthetic
20% benzocaine gel (Opahl Topical Gel)
1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000
Local dental anesthetic agent
Interventions
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Buzzy System
Vibrating Device
Topical anesthetic
20% benzocaine gel (Opahl Topical Gel)
1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000
Local dental anesthetic agent
Eligibility Criteria
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Inclusion Criteria
2. Children aged 5-8 years old.
3. Patients who need maxillary buccal infiltration anesthesia.
Exclusion Criteria
2. Children with known allergy to topical or local anesthetic agents.
3. Parental refusal for participation.
4. Children with previous history of local anesthesia injection.
5 Years
8 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Fatma Mahmoud Mohamed Mahmoud
Principal Investigator
Locations
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Faculty of dentistry, Cairo University
Cairo, Manial, Egypt
Countries
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References
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Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.
Hegde KM, R N, Srinivasan I, D R MK, Melwani A, Radhakrishna S. Effect of vibration during local anesthesia administration on pain, anxiety, and behavior of pediatric patients aged 6-11 years: A crossover split-mouth study. J Dent Anesth Pain Med. 2019 Jun;19(3):143-149. doi: 10.17245/jdapm.2019.19.3.143. Epub 2019 Jun 30.
Alanazi KJ, Pani S, AlGhanim N. Efficacy of external cold and a vibrating device in reducing discomfort of dental injections in children: A split mouth randomised crossover study. Eur Arch Paediatr Dent. 2019 Apr;20(2):79-84. doi: 10.1007/s40368-018-0399-8. Epub 2018 Dec 5.
Suohu T, Sharma S, Marwah N, Mishra P. A Comparative Evaluation of Pain Perception and Comfort of a Patient Using Conventional Syringe and Buzzy System. Int J Clin Pediatr Dent. 2020 Jan-Feb;13(1):27-30. doi: 10.5005/jp-journals-10005-1731.
AlHareky M, AlHumaid J, Bedi S, El Tantawi M, AlGahtani M, AlYousef Y. Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial. Int J Dent. 2021 Jan 30;2021:8896408. doi: 10.1155/2021/8896408. eCollection 2021.
Faghihian R, Rastghalam N, Amrollahi N, Tarrahi MJ. Effect of vibration devices on pain associated with dental injections in children: A systematic review and meta-analysis. Aust Dent J. 2021 Mar;66(1):4-12. doi: 10.1111/adj.12811. Epub 2020 Dec 17.
Zielinski J, Morawska-Kochman M, Zatonski T. Pain assessment and management in children in the postoperative period: A review of the most commonly used postoperative pain assessment tools, new diagnostic methods and the latest guidelines for postoperative pain therapy in children. Adv Clin Exp Med. 2020 Mar;29(3):365-374. doi: 10.17219/acem/112600.
Hindocha N, Manhem F, Backryd E, Bagesund M. Ice versus lidocaine 5% gel for topical anaesthesia of oral mucosa - a randomized cross-over study. BMC Anesthesiol. 2019 Dec 16;19(1):227. doi: 10.1186/s12871-019-0902-8.
Al-Melh MA, Andersson L. Comparison of topical anesthetics (EMLA/Oraqix vs. benzocaine) on pain experienced during palatal needle injection. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e16-20. doi: 10.1016/j.tripleo.2006.11.033. Epub 2007 Feb 27.
Other Identifiers
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Buzzy System in Children.
Identifier Type: -
Identifier Source: org_study_id
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