Pain Perception of Needle-free System

Pain Clinical Trial

Official title:

Comparative Evaluation of Pain Perception With a New Needle-Free System and Dental Injection in Children: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04653974
• Other study ID #: U1111-1257-5993
• Status: Completed
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: August 5, 2019

Study information

• Verified date: December 2020
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and compare the pain perception associated with a needle-free injection system( Comfort-In) and dental injection method in filling and pulpotomy treatments

Description:

Needle-free injection system(Comfort-In) and dental injection method was applied on the teeth of children who need dental treatment.70 patients were included in the study. Patients were randomized into two grups according to the injection technique. Group1: Needle-free injection system(Comofrt-In) 2:Dental injection method. The pain intensity was assessed during anesthesia, during treatment and at the end of thetreatment by the Wong Baker Faces Pain Scale. The datas were analyzed with a three-way variance method in repeated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 5, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

Inclusion Criteria:

• Aged between 4-11 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

Exclusion Criteria:

• Patients younger than five years, older than 11 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.

Related Conditions & MeSH terms

• Anxiety
• Dental Fear
• Local Anesthesia
• Needle Phobia
• Pain

Intervention

Behavioral:
• Needle-free injection
This study was performed among children aged 4-11 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 70 patients were evaluated in accordance with the exclusion criteria and 56 children (31 girls and 25 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 Wong-Baker Pain Scale at three time points: immediately after injection (Pain 1), during treatment (Pain 2), and at the end of the treatment (Pain 3).

Locations

Country	Name	City	State
Turkey	Tokat Gaziosmanpasa University, Faculty of Dentistry	Tokat	Center

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

References & Publications (19)

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Asarch T, Allen K, Petersen B, Beiraghi S. Efficacy of a computerized local anesthesia device in pediatric dentistry. Pediatr Dent. 1999 Nov-Dec;21(7):421-4. — View Citation

Baghlaf K, Alamoudi N, Elashiry E, Farsi N, El Derwi DA, Abdullah AM. The pain-related behavior and pain perception associated with computerized anesthesia in pulpotomies of mandibular primary molars: A randomized controlled trial. Quintessence Int. 2015 Oct;46(9):799-806. doi: 10.3290/j.qi.a34553. — View Citation

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Goodell GG, Gallagher FJ, Nicoll BK. Comparison of a controlled injection pressure system with a conventional technique. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Jul;90(1):88-94. — View Citation

Greenfield W, Karpinski JF. Clinical application of jet injection to comprehensive pain control. Anesth Prog. 1973 Jul-Aug;20(4):110-2. — View Citation

Kuensting LL, DeBoer S, Holleran R, Shultz BL, Steinmann RA, Venella J. Difficult venous access in children: taking control. J Emerg Nurs. 2009 Sep;35(5):419-24. doi: 10.1016/j.jen.2009.01.014. Epub 2009 Mar 21. Review. — View Citation

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. — View Citation

Milgrom P, Coldwell SE, Getz T, Weinstein P, Ramsay DS. Four dimensions of fear of dental injections. J Am Dent Assoc. 1997 Jun;128(6):756-66. — View Citation

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. — View Citation

Ocak H, Akkoyun EF, Çolpak HA, Demetoglu U, Yücesoy T, Kiliç 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. — View Citation

Ogle OE, Mahjoubi G. Advances in local anesthesia in dentistry. Dent Clin North Am. 2011 Jul;55(3):481-99, viii. doi: 10.1016/j.cden.2011.02.007. Review. — View Citation

Oliveira ACA, Amorim KS, Nascimento Júnior 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. — View Citation

Oosterink FM, de Jongh A, Aartman IH. What are people afraid of during dental treatment? Anxiety-provoking capacity of 67 stimuli characteristic of the dental setting. Eur J Oral Sci. 2008 Feb;116(1):44-51. doi: 10.1111/j.1600-0722.2007.00500.x. — View Citation

Oztas N, Olmez A, Yel B. Clinical evaluation of transcutaneous electronic nerve stimulation for pain control during tooth preparation. Quintessence Int. 1997 Sep;28(9):603-8. — View Citation

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. — View Citation

Sermet Elbay Ü, 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. — View Citation

Splieth CH, Bünger B, Pine C. Barriers for dental treatment of primary teeth in East and West Germany. Int J Paediatr Dent. 2009 Mar;19(2):84-90. doi: 10.1111/j.1365-263X.2008.00949.x. Epub 2008 Dec 19. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	after dental treatments to 24 hour