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

March 24, 2024 updated by: Irem Bag, Eskisehir Osmangazi University

Comparison of Pain and Anxiety Levels of Sleeperone 5 Electronic Anesthesia System and Conventional Local Anesthesia Techniques in Pediatric Patients: a Randomised Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Eskişehir, Turkey
        • Eskisehir Osmangazi University Faculty of Dentistry, Department of Pediatric Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
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.
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.
Other: pulse rate
Before starting anesthesia and after the anesthesia the patient's pulse rate was measured and recorded with a pulse oximeter.
Experimental: 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.
Other: 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.
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.
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.
Other: pulse rate
Before starting anesthesia and after the anesthesia the patient's pulse rate was measured and recorded with a pulse oximeter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pulse rate measurements before and after the anesthesia techniques
Time Frame: 7 months
Application and recording of scale measurements of pulse rate before and after the anesthesia techniques (normal 70-120 bpm)
7 months
Determine the anxiety level before the procedures
Time Frame: 7 months
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.
7 months
The anxiety measurements before and after the anesthesia techniques
Time Frame: 7 months
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)
7 months
The pain measurements during the anesthesia techniques
Time Frame: 7 months
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.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2023

Primary Completion (Actual)

October 2, 2023

Study Completion (Actual)

November 15, 2023

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 24, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Other researchers will be able to access the individual participant data from the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe