Pain Perception With a Comfort-ın Jet Injection and Conventional Dental Injection
NCT ID: NCT04682080
Last Updated: 2020-12-23
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
94 participants
INTERVENTIONAL
2018-06-20
2019-06-20
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(Pain 1), during treatment(Pain 2), at the end of the treatment(Pain 3) and on the postoperative 1st day (Pain 4)by the specially 7 colors (white, yellow, green, blue, magenta, red, black) using the Wong-Baker facial expressions and pain grading scale.Anxiety levels were recorded using the Modified Children's Dental Anxiety Scale face version.
The data were analyzed by IBM SPSS Statistics 19, the significance level was taken as p \<0.05.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, 4% articaine with 1/100.000 epinephrine (Ultracaine DS forte) was injected using the Comfort-In system. Pain intensity and anxiety levels of patients were measured.
Needle-free injection
This study was performed among children aged 4-10 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 120 patients were evaluated in accordance with the exclusion criteria and 94 children (39 girls and 55 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 colorful Wong-Baker Pain Scale at four time points: immediately after injection (Pain 1), during treatment (Pain 2), at the end of the treatment (Pain 3) and postoperative first day.Anxiety levels were recorded using the Modified Children's Dental Anxiety Scale face version
Dental injection group
In the conventional dental-injection method, 4% articaine with 1/100.000 epinephrine (Ultracaine DS forte) was injected using a 27G, 50-mm, disposable syringe with a needle. Pain intensity and anxiety levels of patients were measured.
Needle-free injection
This study was performed among children aged 4-10 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 120 patients were evaluated in accordance with the exclusion criteria and 94 children (39 girls and 55 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 colorful Wong-Baker Pain Scale at four time points: immediately after injection (Pain 1), during treatment (Pain 2), at the end of the treatment (Pain 3) and postoperative first day.Anxiety levels were recorded using the Modified Children's Dental Anxiety Scale face version
Interventions
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Needle-free injection
This study was performed among children aged 4-10 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 120 patients were evaluated in accordance with the exclusion criteria and 94 children (39 girls and 55 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 colorful Wong-Baker Pain Scale at four time points: immediately after injection (Pain 1), during treatment (Pain 2), at the end of the treatment (Pain 3) and postoperative first day.Anxiety levels were recorded using the Modified Children's Dental Anxiety Scale face version
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
10 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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Altan H, Cevik H, Dogru S, Cosgun A, Suren M, Okan I. The pain colour of children with toothache in Turkish population. BMC Oral Health. 2019 Apr 18;19(1):59. doi: 10.1186/s12903-019-0756-y.
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.
Armfield JM. Development and psychometric evaluation of the Index of Dental Anxiety and Fear (IDAF-4C+). Psychol Assess. 2010 Jun;22(2):279-87. doi: 10.1037/a0018678.
Burkitt E, Barrett M, Davis A. Children's colour choices for completing drawings of affectively characterised topics. J Child Psychol Psychiatry. 2003 Mar;44(3):445-55. doi: 10.1111/1469-7610.00134.
Howard KE, Freeman R. Reliability and validity of a faces version of the Modified Child Dental Anxiety Scale. Int J Paediatr Dent. 2007 Jul;17(4):281-8. doi: 10.1111/j.1365-263X.2007.00830.x.
Khatri A, Kalra N. A comparison of two pain scales in the assessment of dental pain in East delhi children. ISRN Dent. 2012;2012:247351. doi: 10.5402/2012/247351. Epub 2012 Feb 14.
Langthasa M, Yeluri R, Jain AA, Munshi AK. Comparison of the pain perception in children using comfort control syringe and a conventional injection technique during pediatric dental procedures. J Indian Soc Pedod Prev Dent. 2012 Oct-Dec;30(4):323-8. doi: 10.4103/0970-4388.108931.
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.
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.
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.
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.
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.
Wogelius P, Poulsen S, Sorensen HT. Prevalence of dental anxiety and behavior management problems among six to eight years old Danish children. Acta Odontol Scand. 2003 Jun;61(3):178-83. doi: 10.1080/00016350310003468.
Other Identifiers
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2018/33
Identifier Type: -
Identifier Source: org_study_id