Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2019-03-11
2019-08-05
Brief Summary
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Detailed Description
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Group1: Needle-free injection system(Comofrt-In) 2:Dental injection method. The pain intensity was assessed during anesthesia, during treatment and at the end of thetreatment by the Wong Baker Faces Pain Scale.
The datas were analyzed with a three-way variance method in repeated.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Needle-free injection group
In needle-free injection techniques, 2% lidocaine with 1/80.000 epinephrine (Lidocaine, Colombia) was injected using the Comfort-In system.
Needle-free injection
This study was performed among children aged 4-11 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 70 patients were evaluated in accordance with the exclusion criteria and 56 children (31 girls and 25 boys) were included in this study. Children who needed dental treatment were randomly divided into two groups. All dental injections were administered by the same operator (MB), a pediatric dentist with two years of experience in using the Comfort-In system.
In both groups, the children were asked to rate their pain intensity by choosing the closest statement on the Wong-Baker Pain Scale at three time points: immediately after injection (Pain 1), during treatment (Pain 2), and at the end of the treatment (Pain 3).
Dental injection group
In the conventional dental-injection method, 2% lidocaine with 1/80.000 epinephrine (Lidocaine, Colombia) was injected using a 27G, 40-mm, disposable syringe with a needle.
Needle-free injection
This study was performed among children aged 4-11 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 70 patients were evaluated in accordance with the exclusion criteria and 56 children (31 girls and 25 boys) were included in this study. Children who needed dental treatment were randomly divided into two groups. All dental injections were administered by the same operator (MB), a pediatric dentist with two years of experience in using the Comfort-In system.
In both groups, the children were asked to rate their pain intensity by choosing the closest statement on the Wong-Baker Pain Scale at three time points: immediately after injection (Pain 1), during treatment (Pain 2), and at the end of the treatment (Pain 3).
Interventions
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Needle-free injection
This study was performed among children aged 4-11 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 70 patients were evaluated in accordance with the exclusion criteria and 56 children (31 girls and 25 boys) were included in this study. Children who needed dental treatment were randomly divided into two groups. All dental injections were administered by the same operator (MB), a pediatric dentist with two years of experience in using the Comfort-In system.
In both groups, the children were asked to rate their pain intensity by choosing the closest statement on the Wong-Baker Pain Scale at three time points: immediately after injection (Pain 1), during treatment (Pain 2), and at the end of the treatment (Pain 3).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having no developmental or systemic disorder or no history of allergy
* Having "positive" or "definitely positive" cooperation level according to the Frankl Behavior Scale
* Having sufficient mouth opening
* Operation only on primary teeth
* Having decayed teeth that require anesthesia
Exclusion Criteria
* Patients with systemic or developmental disorders
* Children with an allergy history
* 'Negative' or 'definitly negative' behavior rating according to the Frankl scale
* Patients whose mouth opening is not sufficient for dental treatment
* Operating only on permanent teeth
* Teeth that are beyond the treatment stage
* When pain occurred during treatment, supplemental anesthetics administrated, and these children were excluded.
4 Years
11 Years
ALL
Yes
Sponsors
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Tokat Gaziosmanpasa University
OTHER
Responsible Party
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Halenur Altan
Associated Professor
Principal Investigators
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Halenur Altan, Assoc Prof.
Role: PRINCIPAL_INVESTIGATOR
Tokat Gaziosmanpasa University, Faculty of Dentistry, Department of Pediatric Dentistry
Locations
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Tokat Gaziosmanpasa University, Faculty of Dentistry
Tokat Province, Center, Turkey (Türkiye)
Countries
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References
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Makade CS, Shenoi PR, Gunwal MK. Comparison of acceptance, preference and efficacy between pressure anesthesia and classical needle infiltration anesthesia for dental restorative procedures in adult patients. J Conserv Dent. 2014 Mar;17(2):169-74. doi: 10.4103/0972-0707.128063.
Arapostathis KN, Dabarakis NN, Coolidge T, Tsirlis A, Kotsanos N. Comparison of acceptance, preference, and efficacy between jet injection INJEX and local infiltration anesthesia in 6 to 11 year old dental patients. Anesth Prog. 2010 Spring;57(1):3-12. doi: 10.2344/0003-3006-57.1.3.
Oliveira ACA, Amorim KS, Nascimento Junior EMD, Duarte ACB, Groppo FC, Takeshita WM, Souza LMA. Assessment of anesthetic properties and pain during needleless jet injection anesthesia: a randomized clinical trial. J Appl Oral Sci. 2019 Jan 14;27:e20180195. doi: 10.1590/1678-7757-2018-0195.
Greenfield W, Karpinski JF. Clinical application of jet injection to comprehensive pain control. Anesth Prog. 1973 Jul-Aug;20(4):110-2. No abstract available.
Saravia ME, Bush JP. The needleless syringe: efficacy of anesthesia and patient preference in child dental patients. J Clin Pediatr Dent. 1991 Winter;15(2):109-12.
Baghlaf K, Alamoudi N, Elashiry E, Farsi N, El Derwi DA, Abdullah AM. The pain-related behavior and pain perception associated with computerized anesthesia in pulpotomies of mandibular primary molars: A randomized controlled trial. Quintessence Int. 2015 Oct;46(9):799-806. doi: 10.3290/j.qi.a34553.
Munshi AK, Hegde A, Bashir N. Clinical evaluation of the efficacy of anesthesia and patient preference using the needle-less jet syringe in pediatric dental practice. J Clin Pediatr Dent. 2001 Winter;25(2):131-6. doi: 10.17796/jcpd.25.2.q6426p853266q575.
Ogle OE, Mahjoubi G. Advances in local anesthesia in dentistry. Dent Clin North Am. 2011 Jul;55(3):481-99, viii. doi: 10.1016/j.cden.2011.02.007.
Sermet Elbay U, Elbay M, Yildirim S, Kaya E, Kaya C, Ugurluel C, BaydemIr C. Evaluation of the injection pain with the use of DentalVibe injection system during supraperiosteal anaesthesia in children: a randomised clinical trial. Int J Paediatr Dent. 2016 Sep;26(5):336-45. doi: 10.1111/ipd.12204. Epub 2015 Sep 15.
Oztas N, Olmez A, Yel B. Clinical evaluation of transcutaneous electronic nerve stimulation for pain control during tooth preparation. Quintessence Int. 1997 Sep;28(9):603-8.
Goodell GG, Gallagher FJ, Nicoll BK. Comparison of a controlled injection pressure system with a conventional technique. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Jul;90(1):88-94. doi: 10.1067/moe.2000.107365.
Gibson RS, Allen K, Hutfless S, Beiraghi S. The Wand vs. traditional injection: a comparison of pain related behaviors. Pediatr Dent. 2000 Nov-Dec;22(6):458-62.
Asarch T, Allen K, Petersen B, Beiraghi S. Efficacy of a computerized local anesthesia device in pediatric dentistry. Pediatr Dent. 1999 Nov-Dec;21(7):421-4.
Ocak H, Akkoyun EF, Colpak HA, Demetoglu U, Yucesoy T, Kilic E, Alkan A. Is the jet injection effective for teeth extraction? J Stomatol Oral Maxillofac Surg. 2020 Feb;121(1):19-24. doi: 10.1016/j.jormas.2019.05.001. Epub 2019 May 8.
Kuensting LL, DeBoer S, Holleran R, Shultz BL, Steinmann RA, Venella J. Difficult venous access in children: taking control. J Emerg Nurs. 2009 Sep;35(5):419-24. doi: 10.1016/j.jen.2009.01.014. Epub 2009 Mar 21. No abstract available.
Milgrom P, Coldwell SE, Getz T, Weinstein P, Ramsay DS. Four dimensions of fear of dental injections. J Am Dent Assoc. 1997 Jun;128(6):756-66. doi: 10.14219/jada.archive.1997.0301.
Splieth CH, Bunger B, Pine C. Barriers for dental treatment of primary teeth in East and West Germany. Int J Paediatr Dent. 2009 Mar;19(2):84-90. doi: 10.1111/j.1365-263X.2008.00949.x. Epub 2008 Dec 19.
Oosterink FM, de Jongh A, Aartman IH. What are people afraid of during dental treatment? Anxiety-provoking capacity of 67 stimuli characteristic of the dental setting. Eur J Oral Sci. 2008 Feb;116(1):44-51. doi: 10.1111/j.1600-0722.2007.00500.x.
Deepak V, Challa RR, Kamatham R, Nuvvula S. Comparison of a New Auto-controlled Injection System with Traditional Syringe for Mandibular Infiltrations in Children: A Randomized Clinical Trial. Anesth Essays Res. 2017 Apr-Jun;11(2):431-438. doi: 10.4103/0259-1162.194535.
Altan H, Belevcikli M, Cosgun A, Demir O. Comparative evaluation of pain perception with a new needle-free system and dental needle method in children: a randomized clinical trial. BMC Anesthesiol. 2021 Dec 1;21(1):301. doi: 10.1186/s12871-021-01524-1.
Other Identifiers
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U1111-1257-5993
Identifier Type: -
Identifier Source: org_study_id