An interventional study of Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale and Face Image Scale (FIS) scoring system in Dental Anxiety and Pain, sponsored by Eskisehir Osmangazi University. Completed at 1 site in Turkey. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Eskisehir Osmangazi University · Not applicable, Interventional, and Other
The conventional method used for dental anesthesia in children is the administration of a local anesthetic solution by injection. Although this process successfully eliminates pain during the procedure, it continues to be a problem for many children in terms of dental anxiety before and during anesthesia administration.
The aim of this study is to compare intraosseous anesthesia with SleeperOne® 5, a computer-assisted local anesthesia system, with conventional local anesthesia techniques in terms of pain and anxiety.
In the conventional injection technique, painful local swelling of the tissues at the injection site occurs during the administration of local anesthetics. Failure to control the rate of administration of anesthesia increases pain, swelling and tissue tension, leading to the discomfort and unpleasant sensations that accompany local anesthesia. In addition, an uncontrolled and shocking increase in pressure in the anesthetized tissues can lead to short-term blood supply disturbances and local damage, reducing the effectiveness of anesthesia and increasing the risk of side effects. It has been reported that the pain felt during anesthesia is mostly caused by the inability to control the pressure generated during the injection of the solution. To overcome these shortcomings, the search for new alternative and minimally invasive methods of local anesthesia has been in the limelight with better pain control, reduced injection pain and improved quality of treatment for pedodontic procedures. With the use of computer-assisted local anesthesia systems, the anesthetic solution is administered gradually and the tissue pressure during anesthesia can be controlled. Thus, a less painful and more comfortable anesthesia experience can be provided. SleeperOne® 5, one of the computer-assisted local anesthesia systems, is a device with advantages such as ease of use, less intimidating physical appearance of the needle, no need for pressure during injection, guided entry points to the injection site. There are no previous studies comparing the use of intraosseous technique with SleeperOne® 5 device and conventional mandibular anesthesia in mandibular permanent molars. In this study, the investigators aimed to compare the pain and anxiety caused by the SleeperOne® 5 anesthesia system in children compared to traditional anesthesia methods, of which there are few studies in the literature. The first null hypothesis (H0) of the study is that there is no difference between intraosseous anesthesia administered with SleeperOne® 5 computer-assisted anesthesia systems and buccal infiltration and mandibular anesthesia administered with conventional methods in terms of anxiety in patients. The second null hypothesis of the study is that there is no difference between intraosseous anesthesia performed with SleeperOne® 5 computer-assisted anesthesia systems and buccal infiltration and mandibular anesthesia performed with conventional methods in terms of pain.
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This study's enrollment of 32 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
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Exclusion Criteria:
* A half of upper jaw: Electronic local anesthesia technique (SleeperOne) A topical anesthetic spray containing 10% lidocaine was applied with a cotton pellet for 1 minute.The SleeperOne® 5 (Dentalhitec, Mazières-en-Mauges, France) device was used with 30 gauge-0.30x09 mm Effitec needle tips for intraosseous anesthesia. The anesthesia was applied in child mode according to the manufacturer.1 ml of local anesthetic solution (Ultracaine D-S Fort) was applied for 1 minute. * The contralateral half of the upper jaw: Infiltrative anesthesia (conventional) After confirming the vitality of the tooth, a topical anesthetic spray was applied with a cotton pellet for 1 minute. A local anesthetic, Maxicaine Forte, was administered for 1.5 ml for 1 minute using buccal infiltration anesthesia technique using short syringes.
Other: Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale · Other: Face Image Scale (FIS) scoring system · Other: Visual Analogue Scale (VAS) · Other: pulse rate
* A half of lower jaw: Electronic local anesthesia technique (SleeperOne) A topical anesthetic spray containing 10% lidocaine was applied with a cotton pellet for 1 minute.The SleeperOne® 5 (Dentalhitec, Mazières-en-Mauges, France) device was used with 30 gauge-0.30x09 mm Effitec needle tips for intraosseous anesthesia. The anesthesia was applied in child mode according to the manufacturer.1 ml of local anesthetic solution (Ultracaine D-S Fort) was applied for 1 minute. * The contralateral half of the lower jaw: mandibular anesthesia (conventional) After topical anesthesia, mandibular anesthesia with Maxicaine Forte,in an amount of 1.8 ml was administered for 1 minute using long syringes.
Other: Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale · Other: Face Image Scale (FIS) scoring system · Other: Visual Analogue Scale (VAS) · Other: pulse rate
Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale was applied to determine the anxiety level before the procedure.
Face Image Scale (FIS) scoring system (1= not afraid at all, 2= very little afraid, 3= afraid, 4= quite afraid, 5= very much afraid) was used to determine the anxiety level before starting anesthesia and after the anesthesia.
In the Visual Analogue Scale (VAS), the patient was asked to rate the pain he/she felt during anesthesia on a 10 cm long ruler ranging from no pain=0 to unbearable pain=10.
Before starting anesthesia and after the anesthesia the patient's pulse rate was measured and recorded with a pulse oximeter.
The pulse rate measurements before and after the anesthesia techniques
Application and recording of scale measurements of pulse rate before and after the anesthesia techniques (normal 70-120 bpm)
Time frame: 7 months
Determine the anxiety level before the procedures
Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale before the anesthesia procedures. A score between 1 and 5 was made according to the answers given to each question in this scale (1 point = not at all afraid, 2 points = slightly afraid, 3 points = moderately afraid, 4 points = quite afraid, 5 points = very afraid). If the score obtained from the CFSS-DS measurement results is below 38, it is considered as non-anxious, between 38-45 as significant dental anxiety, and as 45 and above as high level dental anxiety.
Time frame: 7 months
The anxiety measurements before and after the anesthesia techniques
Application and recording of scale measurements of Face Image Scale (FIS) scoring system before and after the anesthesia techniques.(1= not afraid at all, 2= very little afraid, 3= afraid, 4= quite afraid, 5= very much afraid)
Time frame: 7 months
The pain measurements during the anesthesia techniques
In the Visual Analogue Scale (VAS), the patient was asked to rate the pain he/she felt during anesthesia on a 10 cm long ruler ranging from no pain=0 to unbearable pain=10. The results were recorded on the forms.
Time frame: 7 months
Plan to share: Yes — Other researchers will be able to access the individual participant data from the corresponding author.
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Eskisehir Osmangazi University