Pain Perception With a Comfort-ın Jet Injection and Conventional Dental Injection

NCT04682080 | Completed

• 1 other identifier: 2018/33
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Local Infiltration; Anesthesia; Fear; Anxiety; Needle Phobia

Keywords

Comfort-in jet injection system; needle-free injection; dental pain; dental anxiety and fear; color of pain

Outcome Measures

Primary Outcomes (4)

• 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).

Study Arms (2)

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.

Behavioral: Needle-free injection

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.

Behavioral: Needle-free injection

Interventions

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

Also known as: Dental injection

Dental injection group; Needle-free injection group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 4-10 years
• Having no developmental or systemic disorder or no history of allergy
• Having "positive" or "definitely positive" cooperation level according to the Frankl Behavior Scale
• Having sufficient mouth opening
• Operation only on primary teeth
• Having decayed teeth that require anesthesia

You may not qualify if:

• Patients younger than four years, older than 10 years,
• Patients with systemic or developmental disorders
• Children with an allergy history
• 'Negative' or 'definitly negative' behavior rating according to the Frankl scale
• Patients whose mouth opening is not sufficient for dental treatment
• Operating only on permanent teeth
• Teeth that are beyond the treatment stage
• When pain occurred during treatment, supplemental anesthetics administrated, and these children were excluded.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa University, Faculty of Dentistry

Tokat Province, Center, 60250, Turkey (Türkiye)

Location

Related Publications (14)

• 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.

  PMID: 30999904 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.

  PMID: 20331333 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.

  PMID: 30673030 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.

  PMID: 20528055 BACKGROUND

• Burkitt E, Barrett M, Davis A. Children's colour choices for completing drawings of affectively characterised topics. J Child Psychol Psychiatry. 2003 Mar;44(3):445-55. doi: 10.1111/1469-7610.00134.

  PMID: 12635973 BACKGROUND

• Howard KE, Freeman R. Reliability and validity of a faces version of the Modified Child Dental Anxiety Scale. Int J Paediatr Dent. 2007 Jul;17(4):281-8. doi: 10.1111/j.1365-263X.2007.00830.x.

  PMID: 17559456 BACKGROUND

• Khatri A, Kalra N. A comparison of two pain scales in the assessment of dental pain in East delhi children. ISRN Dent. 2012;2012:247351. doi: 10.5402/2012/247351. Epub 2012 Feb 14.

  PMID: 22461986 BACKGROUND

• Langthasa M, Yeluri R, Jain AA, Munshi AK. Comparison of the pain perception in children using comfort control syringe and a conventional injection technique during pediatric dental procedures. J Indian Soc Pedod Prev Dent. 2012 Oct-Dec;30(4):323-8. doi: 10.4103/0970-4388.108931.

  PMID: 23514685 BACKGROUND

• Makade CS, Shenoi PR, Gunwal MK. Comparison of acceptance, preference and efficacy between pressure anesthesia and classical needle infiltration anesthesia for dental restorative procedures in adult patients. J Conserv Dent. 2014 Mar;17(2):169-74. doi: 10.4103/0972-0707.128063.

  PMID: 24778516 BACKGROUND

• Ocak H, Akkoyun EF, Colpak HA, Demetoglu U, Yucesoy T, Kilic E, Alkan A. Is the jet injection effective for teeth extraction? J Stomatol Oral Maxillofac Surg. 2020 Feb;121(1):19-24. doi: 10.1016/j.jormas.2019.05.001. Epub 2019 May 8.

  PMID: 31077857 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.

  PMID: 11314212 BACKGROUND

• Saravia ME, Bush JP. The needleless syringe: efficacy of anesthesia and patient preference in child dental patients. J Clin Pediatr Dent. 1991 Winter;15(2):109-12.

  PMID: 1931745 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.

  PMID: 26369274 BACKGROUND

• Wogelius P, Poulsen S, Sorensen HT. Prevalence of dental anxiety and behavior management problems among six to eight years old Danish children. Acta Odontol Scand. 2003 Jun;61(3):178-83. doi: 10.1080/00016350310003468.

  PMID: 12868693 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders; Toothache

Interventions

Dental Health Services

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Tooth Diseases; Stomatognathic Diseases; Facial Pain

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Halenur Altan, Assoc Prof.

  Tokat Gaziosmanpasa University, Faculty of Dentistry, Department of Pediatric Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 23, 2020
• Study Start: June 20, 2018
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

TU (1)