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

NCT06340022 | Completed

• 1 other identifier: 2022-31
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety; Pain

Keywords

Dental Anxiety; Intraosseous Anesthesia; Pain; SleeperOne

Outcome Measures

Primary Outcomes (4)

• 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)

  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.

  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)

  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.

  7 months

Study Arms (2)

Upper jaw

EXPERIMENTAL

* 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

Lower jaw

EXPERIMENTAL

* 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

Interventions

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

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

Lower jaw; Upper jaw

Face Image Scale (FIS) scoring system 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.

Lower jaw; Upper jaw

Visual Analogue Scale (VAS) 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.

Lower jaw; Upper jaw

pulse rate OTHER

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

Lower jaw; Upper jaw

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University Faculty of Dentistry, Department of Pediatric Dentistry

Eskişehir, Turkey (Türkiye)

Location

Related Publications (7)

• Sixou JL, Marie-Cousin A, Huet A, Hingant B, Robert JC. Pain assessment by children and adolescents during intraosseous anaesthesia using a computerized system (QuickSleeper). Int J Paediatr Dent. 2009 Sep;19(5):360-6. doi: 10.1111/j.1365-263X.2009.00983.x. Epub 2009 Apr 14.

  PMID: 19486372 BACKGROUND

• Sovatdy S, Vorakulpipat C, Kiattavorncharoen S, Saengsirinavin C, Wongsirichat N. Inferior alveolar nerve block by intraosseous injection with Quicksleeper(R) at the retromolar area in mandibular third molar surgery. J Dent Anesth Pain Med. 2018 Dec;18(6):339-347. doi: 10.17245/jdapm.2018.18.6.339. Epub 2018 Dec 28.

  PMID: 30637344 BACKGROUND

• Beneito-Brotons R, Penarrocha-Oltra D, Ata-Ali J, Penarrocha M. Intraosseous anesthesia with solution injection controlled by a computerized system versus conventional oral anesthesia: a preliminary study. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e426-9. doi: 10.4317/medoral.17543.

  PMID: 22143722 BACKGROUND

• Dempsy Chengappa MM, Prashanth AK. Evaluation of efficacy of computer-controlled local anaesthetic delivery system vs traditional injection system for minor pediatric surgical procedures in children. Med J Armed Forces India. 2022 Sep;78(Suppl 1):S89-S95. doi: 10.1016/j.mjafi.2020.08.010. Epub 2020 Nov 2.

  PMID: 36147427 BACKGROUND

• Angelo Z, Polyvios C. Alternative practices of achieving anaesthesia for dental procedures: a review. J Dent Anesth Pain Med. 2018 Apr;18(2):79-88. doi: 10.17245/jdapm.2018.18.2.79. Epub 2018 Apr 27.

  PMID: 29744382 BACKGROUND

• Versloot J, Veerkamp JS, Hoogstraten J. Computerized anesthesia delivery system vs. traditional syringe: comparing pain and pain-related behavior in children. Eur J Oral Sci. 2005 Dec;113(6):488-93. doi: 10.1111/j.1600-0722.2005.00252.x.

  PMID: 16324138 BACKGROUND

• Anil O, Keskin G. Comparison of computer controlled local anesthetic delivery and traditional injection regarding disruptive behaviour, pain, anxiety and biochemical parameters: a randomized controlled trial. J Clin Pediatr Dent. 2024 Jan;48(1):120-127. doi: 10.22514/jocpd.2023.046. Epub 2024 Jan 3.

  PMID: 38239164 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Weights and Measures; Heart Rate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Model Details: The study was a single-center randomized controlled trial using a split mouth design with a 1:1 split ratio.

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 1, 2024
• Study Start: March 13, 2023
• Primary Completion: October 2, 2023
• Study Completion: November 15, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)