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The investigators aimed to compare the effectiveness of the Comfort-in system, which is a jet injection type, and infiltrative anesthesia with a traditional injector, and to measure the effect of children's anxiety on the severity of pain.
Among the children between the ages of 4 and 10 who were admitted to clinic between 2018-2020, whose clinical and radiographic examinations were completed; Patients with deciduous teeth that needed the same dental treatment (filling or amputation) with symmetrical local anesthesia application and positive (3) or definitely positive (4) according to the Frankl Behavior Evaluation Scale were included in the study. In study with a split-mouth design, infiltration anesthesia was applied with a conventional dental injector to one of the symmetrical teeth requiring the same treatment, while the Comfort-in jet injection system was applied to the other by the same physician. Patients were randomized into two grups according to the injection technique.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Needle-free injection group | Active Comparator | 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. |
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| Dental injection group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle-free injection | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at different anesthesia methods | The pain perception scores in the two anesthesia methods were assessed with Wong-Baker Pain Scale (Wong-Baker Scale is pain assessment method.It consists of 6 facial expressions that are evaluated from 0 to 10 according to the severity of the pain. Values between 0-4 indicate mild pain, values between 4-6 indicate moderate pain, values between 6-8 indicate severe pain and values between 8-10 indicate unbearable pain). | after dental treatments to 24 hour |
| Anxiety level of children | Anxiety level of children were assesed with Modified Child Dental Anxiety Scale (Modified Child Dental Anxiety Scale is anxiety assessment method. It consist of 8 questions about dental procedures. Each questions are evaluated 5 faces from smiles to cries according to the severity of tne anxiety. Patients with a Modified Child Dental Anxiety Scale value below 26 have less anxiety, and patients with a value of 26 and above have a high level of anxiety. | after dental treatments(40 minutes) |
| Color of pain during anesthesia. | The pain perception scores in the two anesthesia methods were assessed with 7 colorful (white,yellow, green, blue, purple, red and black) Wong-Baker Pain Scale (Wong-Baker Scale is pain assessment method.It consists of 6 facial expressions that are evaluated from 0 to 10 according to the severity of the pain. Values between 0-4 indicate mild pain, values between 4-6 indicate moderate pain, values between 6-8 indicate severe pain and values between 8-10 indicate unbearable pain) | immediately after injection(2 minutes), |
| Children's preferred anesthesia method | Children's preferred anesthesia method was asked for children after two different injection tecniques used. | After using each dental injection method(2 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Halenur Altan, Assoc Prof. | Tokat Gaziosmanpasa University, Faculty of Dentistry, Department of Pediatric Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokat Gaziosmanpasa University, Faculty of Dentistry | Tokat Province | Center | 60250 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30999904 | Background | 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. | |
| 20331333 | Background | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| D014098 | Toothache |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003752 | Dental Health Services |
| ID | Term |
|---|---|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| 30673030 | Background | 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. |
| 20528055 | Background | 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. |
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| 11314212 | Background | 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. |
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| 26369274 | Background | 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. |
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| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |