Pain and Anxiety Levels of Sleeperone Electronic Anesthesia System in Pediatric Patients

NCT ID: NCT06340022

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2023-11-15

Brief Summary

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.

Detailed Description

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.

Conditions

Dental Anxiety; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Upper jaw

• 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.

Group Type: EXPERIMENTAL

Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Visual Analogue Scale (VAS)

Intervention Type: OTHER

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.

pulse rate

Intervention Type: OTHER

Before starting anesthesia and after the anesthesia the patient's pulse rate was measured and recorded with a pulse oximeter.

Lower jaw

• 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.

Group Type: EXPERIMENTAL

Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Visual Analogue Scale (VAS)

Intervention Type: OTHER

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.

pulse rate

Intervention Type: OTHER

Before starting anesthesia and after the anesthesia the patient's pulse rate was measured and recorded with a pulse oximeter.

Interventions

Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale

Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale was applied to determine the anxiety level before the procedure.

Intervention Type: OTHER

Face Image Scale (FIS) scoring system

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.

Intervention Type: OTHER

Visual Analogue Scale (VAS)

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.

Intervention Type: OTHER

pulse rate

Before starting anesthesia and after the anesthesia the patient's pulse rate was measured and recorded with a pulse oximeter.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with ASA 1 general systemic status
• Patients aged 8-12 years
• Patients in Frankl behavior rating score of III and IV
• Asymptomatic teeth
• Patients with carious lesions not exceeding 1/3 of the buccolingual distance between the buccal and lingual pulp crests on the occlusal surfaces of right and left upper/lower permanent first molars with complete apical root development
• Patients with permanent first molars with caries at a minimum dentin 1/2 level and intact dentin at the pulp margin on radiographic evaluation

Exclusion Criteria

• Patients with mild or severe systemic disease, receiving medical treatment
• Patients younger than 8 years and older than 12 years
• Uncooperative, non-compliant patients in the Class I or Class II group according to the Frankl behavior scale
• Teeth with a history of spontaneous pain and tenderness on palpation and percussion
• Patients in need of dental treatment requiring urgent intervention
• Teeth with incomplete apical root development
• Patients with large carious lesions that exceed 1/3 of the distance between the occlusal and buccolingual pulp crests
• Patients with teeth with clinical or radiographic evidence of caries on the interdental or buccal and/or lingual surfaces
• Teeth with caries lesions that do not reach dentin 1/2 on radiographic evaluation or teeth with intact dentin tissue at the pulpal margin

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

Irem Bag

Assoc.Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eskisehir Osmangazi University Faculty of Dentistry, Department of Pediatric Dentistry

Eskişehir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

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Other Identifiers

2022-31

Identifier Type: -

Identifier Source: org_study_id