NumBee versus Traditional Injection: A Comparison of Pain Perception and Efficiency (A Randomized, Split- Mouth Clinical Trail)

doi:10.21203/rs.3.rs-2579302/v1

Download PDF

Research Article

NumBee versus Traditional Injection: A Comparison of Pain Perception and Efficiency (A Randomized, Split- Mouth Clinical Trail)

https://doi.org/10.21203/rs.3.rs-2579302/v1

This work is licensed under a CC BY 4.0 License

Version 1

posted

You are reading this latest preprint version

Objectives: This study compares the anesthetic efficiency of the intraligmentary needless device (NumBee) and traditional dental syringe utilized to anesthetize mandibular 1^st permanent molar, in addition to assessing the pain perception experienced by the subject during anesthesia injection and cavity preparation.

Materials and Methods: Non fearful 30 children aged 6-8 years without a history of exposure to dental anesthesia were chosen to participate in the study using a randomized split-mouth design. All of them were indicated for simple class I dental restoration for both of their mandibular 1^st permanent molars. In two randomized sequential dental treatment sessions, they were administered local anesthesia using NumBee for one of their treated teeth and a conventional dental syringe for the other tooth. The pain perception for both devices during the local anesthetic injection and during cavity preparation was evaluated by using Wong Baker Faces pain scale while the efficiency was recorded according to the reported symptoms during cavity preparation.

Results: Most of girls who injected by NumBee, experienced significantly less pain during the injection than during cavity preparation (p< 0.05). However, when the children were anesthetized with NumBee, the pain experience during cavity preparation was significantly higher than those anesthetized with inferior alveolar nerve block (p<0.05).

Conclusion: NumBee provided a more comfortable and less painful injection as compared to Inferior dental nerve block. However, NumBee gives less anesthetic depth than the inferior alveolar nerve block.

Clinical relevance: The features of the NumBee device, such as the absence of a needle, an appearance that is less likely to provoke anxiety, a reasonable duration of action, and the non-necessity of anesthetizing the entire dental nerve branch, could provide a more comfortable injection, and children might indeed favor it to the traditional syringe.

Trial registration. : No. 576322

Date: 2.6.2022

Anesthetic efficacy

Needless anesthesia

Numbee

Pain perception

Pediatric dentistry.

Pain is a sensory and emotional experience that is impacted by a variety of factors, including physiologic, sensory, affective, cognitive, socio-cultural, and behavioral elements ^[1]. In addition, pain is considered the primary reason why a patient seeks dental treatment. In addition, dental anxiety and fear are the primary reasons why patients may avoid dental appointments ^[2]. In pediatric dentist, it’s crucial to prevent or minimize the pain for a child to build trust and attain a positive experience and cooperation during the dental visit, helping the child o enjoy future dental visits ^[3]. Dental caries remains a worldwide dental concern, affecting individuals of all ages, particularly young children ^[4], although children may find restorative dental care unpleasant because it involves a number of potentially uncomfortable stimuli, all of which can lead to the emergence of dental anxiety. However, the unpleasant sensory experience of local anesthetic injection preoccupies most of the patient’s mind ^{[5, 6, 7]}.

Local anesthesia is regarded as the cornerstone of pain management during dental procedures. It is required in routine pediatric dental procedures such as restorative and surgical procedures ^[8]. The objective fear of the child during the administration of local anesthesia ranges from the sight of the needle to the pain that may be associated with needle injection, increases the patient's anxiety and results in future fear of receiving local anesthesia ^[9] .

A variety of interrelated factors can influence pain perception of the child, including psychological and emotional status, previous pain experience, anxiety level, and how the child is aware of the procedure ¹⁰ Furthermore, numerous factors are associated with the magnitude of pain during injection including the amount of injected anesthesia, type of anesthetic fluid, injection rate, skill of the dentist, location of injection, use of topical anesthesia, and methods of injection. ^[11]. In addition to needle puncture ^[12] .

Variants of the injection device had been released in order to alleviate the children’s pain during local anesthetic injection. Such as computer-controlled local anesthetic delivery (CCLAD), vibrotactile devices, computer-assisted intraosseous anesthesia (CAIO), the Quick sleeper, and the needleless intraligmentary syringe ^[3].

The NumBee (BioDent, Simi Valley, CA) is a novel device that had been claimed to provide atraumatic delivery of local anesthesia without a hypodermic needle ^[12] (Fig. 1). It is a small metal cannula encased in silicone-like material for intraligamentary injections without periodontal ligament penetration.

The NumBee concept involved sealing the NumBee tip to the PDL by advancing it to the gingival sulcus. Local anesthetic is infused into the tissue by slowly pressing the syringe ^[13] Therefore, NumBee was selected in this study to compare with inferior alveolar nerve block (IANB) during a restorative procedure on mandibular permanent first molars in respect to pain perception and the efficiency of pulpal anesthesia.

Study design and participants

In this randomized, split-mouth clinical trial, thirty randomly selected school children who seemed to be healthy, aged 6–8 years with a negative visit to dental clinics, This study adopted a single-blind design to whether technique was employed (NumBee or ‎traditional syringe), Children meeting the inclusion criteria should have no systemic disease history, be indicated for bilateral class I on their mandibular permanent 1st molars, have only initial or moderate caries as per the American Dental Association Dental Caries Classification System 2015 (ACIDAS scores 2/3/4), and be rated as a 3 or 4 on the Frankle behavior rating scale. Children who didn't meet the criterion for participation were excluded.

Setting

Multiple elementary schools in Baghdad/Iraq were enrolled in a survey between June and August 2022. Names of nominated pupils were addressed, and lists were managed according to their school classes. Parents were approached via school "WhatsApp" groups and gauged their willingness in participating in the study. Those who initially agreed to do so were then asked to fill out further details about their children's general health and how they would adhere to the study principles. Operative treatments were carried out in specialized dental institutes in Baghdad, which were chosen to be neighboring the surveyed elementary schools to facilitate the participant’s cooperation.

Sample Calculation And Randomization

The calculation of the sample size was performed by using G power 3.1.9.7 (university of Dusseldorf, Germany) with partial eta square ŋ^{2 =}0.06 (medium effect size) ^[14], power of study = 80%, alpha error of probability = 0.05, the correlation between measures (sides and treatments) is 0.5, and effect size of F is 0.2526, two devices and two sides (two arches) with all these conditions the definitely effect size is 27 subjects adding 10% as an error rate ^[18]. So the sample size is 30 subjects. The Partial eta square effect size range from small (0.01–0.059), medium (0.06–0.139), and large > = 0.14 ^{[14_ 17]}.

A random allocation of sides and treatments and the order of anesthetic technique were generated using Microsoft Excel (Random Number Generation (RNG)) program using a block design.

Intervention

The intervention was started with 1 local anesthetic injection of 2% lidocaine with 1:80,000 epinephrine. Children underwent class I restoration on their mandibular permanent first molar teeth after receiving an IANB on one side and NumBee on the other in two separate sessions. In the IANB a 27- gauge long needle with a standard dental anesthetic syringe was used while a plastic tip which was supplied specifically by the manufacturer was used with NumBee (Fig. 2). Topical anesthesia hadn’t been used prior to injection

For the NumBee injection, each squeeze of the syringe delivers 0.06 mL of the anesthetic solution to the injection site. Two squeezes of NumBee are enough for each injection site. The manufacturer recommends injecting 5 dots on the mandibular permanent 1st molar, this will administer 0.60 mL of anesthetic solution over a duration of 1 minute. ^[19]

Immediately after each injection, the children were subjected to rate the pain experienced during injection using Wong-Baker Faces Pain Scale on a preprinted form (Fig. 3).

The children’s feelings are demonstrated as faces from a smile expression to a crying expression that are described vocally as ("No Hurt" to "Hurts Worst") and the child was asked to choose the face that expresses his / her feeling, the pain scale was well explained to the child prior to utilize the scale to understand numeric ranking from “0” to “10” scales meaning ^[20].

According to the manufacturer, treatment can be initiated immediately after administration following an intraligmentary injection of Numbee ^[13]. While for the IANB technique, 1.5 ml of anesthetic solution was deposited over the course of 60 seconds, and when the needle was withdrawn ^[21].

The waiting for about 3.1 minutes was completed to have the onset of pulpal anesthesia ^[22]. Lip numbness is a significant indicator of the onset of the IANB effect and takes approximately 3.2 minutes to manifest ^[23].

The local anesthesia efficiency was checked by a qualitative statement to whether profound enough for the subject to experience sufficient analgesia during the restorative procedure, If discomfort was experienced by the subject during the restorative procedure, a rescue anesthesia was administered by any method necessary to facilitate completion of the restorative procedure, and the anesthesia was considered to be failed ^[19].

Ethical Consideration

All the rights and welfare of the children were respected. Before any procedures relevant to the study were performed, the parents gave their approval by signing an informed consent form, and they were given a comprehensive explanation of the purpose of the study and how it would be performed. Measures were taken to ensure the privacy and confidentiality of the patients involved in the study, including the elimination of any identifiable data collected prior to and during dental sessions including the patient's phone number and any photos taken of the patient.

Statistical analysis

Data analysis was performed by using Statistical Package for Social ‎Science (SPSS version − 22, Chicago, Illinois, USA), frequency, percentage, and ‎mean rank, inferential statistics were Wilcoxon sign rank tests and Mc ‎Nemare's test. The level of significance was when p value < 0.05.‎

The results show that there were no differences in pain between the two techniques during injections, while there were more children who felt pain during cavity preparation when they were injected by NumBee than children who were anesthetized by IANB with a statistically significant difference. In addition to that, there were more girls injected by NumBee who were affected by pain during the cavity preparation than during injection with a significant difference (p < 0.05) as shown in Table 1.

Table 1: Descriptive and statistical test Wang Baker pain between techniques and steps of treatment

PR=Positive rank, NR=Negative rank, A=Numbee< IANB, B=Numbee> IANB, c=injection cavity

Regarding the pain response after injection (Fig. 3) and during cavity preparation (Fig. 4), the results show that there was a non-significant difference between the two techniques (NumBee and IANB).

By applying Mc Nemare's test of pain during drilling for cavity preparation, there was a non-significant difference between the two techniques. Additionally, the number of children who needed rescue anesthesia was with a non-significant difference in both techniques (Table 2).

Table 2: Descriptive and statistical test of anesthesia efficiency between the two techniques

Dentists strive to perform procedures that cause as little pain or discomfort as possible. In invasive procedures, pain control is typically achieved through the injection of local anesthesia. Although this approach is extremely effective, it is also the most frequently associated with anxiety and negative reactions. ^[24].

As numerous advancements to dental syringes have been made to make it easier for children to receive dental injections, but many of them still have drawbacks linked to the presence of needles or the lengthy duration of delivery of local anesthetic, or may be related to the peculiar noise that occurs upon injection.

This provides the researchers the incentive to introduce a type of intraligmentary needleless syringe (NumBee) and evaluate its effectiveness at providing pulpal anesthetic in addition to the claimed less painful local anesthetic injection.

The reason for choosing NumBee in this study was the needle-free design in a try to lessen the patient’s scaring feelings when they see the needle, especially in the pediatric patients, also it provides single tooth anesthesia without the need to anesthetize the whole nerve branch eliminating the self-inflicted post-operative injury as its rapid onset and give a reasonable duration of operative anesthesia ^[19].

The electric pulp tester (EPT) was not used in this study for checking the depth of anesthesia due to ethical issues concerning its use with children; furthermore, children may get anxious and give the wrong reaction to EPT. Instead, the pulpal anesthetic efficiency was determined by reporting whether or not the child experienced any discomfort during the drilling of carious lesions and whether or not rescue anesthesia was administered to alleviate that discomfort.

Topical anesthesia was not used to topically anesthetize the sites receiving the injections so the children will not miss-assess the pain experienced from Wang_ Baker Face pain scale.

The purpose of achieving the dental procedures on two separate visits other than the same visit is that the procedure would take a long time and might affect the child’s ability to cooperate as the child get tiredness and fatigue leading to incorrect responses.

In this study, the Wong-Baker Faces Pain scale was selected because it’s helpful for assessing pain and is considered as one of the most preferred scales by children ^[25]

Their application is widespread, and their validity is widely accepted, with users preferring cartoon-like depictions. Regardless of their resemblance to a "real" human face, these scales appear to work well across gender and race/ethnicity. Their success may be due in part to their neutrality ^[26].

Despite the fact that girls are more likely to be anxious about anesthesia injections, this study revealed that girls who were anesthetized by NumBee reported significantly less pain during injection ( p < 0.05) . This gives a clue that children are more receptive to NumBee because of its less frightening and it has a more child-friendly appearance and the fact that it makes injections more tolerable as the NumBee tip provides an anesthetic injection with minimal pain perception as compared to the needle supplied in the conventional dental syringe. On the other hand, the majority of the children who were chosen for the study reported that the IANB with a conventional syringe caused them more pain than NumBee.

However, when the children were anesthetized with NumBee, the pain experience during cavity preparation was significantly higher than those anesthetized with IANB (P < 0.05).

Although classified as an intraligmentary type of injection, the NumBee is not advanced into the PDL because its tip is only inserted to the base of the gingival sulcus according to the manufacturer’s instructions ‎^[13].

This can make it less likely for the anesthetic solution to be diffused thoroughly on the marrow spaces of the bone and the surrounding tissue, which explains why NumBee provided a lower level of pulpal anesthetic depth and why children felt more pain during the restorative procedure when compared to IANB which provided more effective anesthesia while also reducing the amount of pain experienced during cavity preparation.

NumBee's pen-like design and the needless tip could make injections less painful for pediatric patients, and the device would be less intimidating to them than a conventional syringe

On the other hand, children anesthetized with IANB reported a more satisfying operative experience

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Consent to publish

Patients signed informed consent regarding publishing their data and photographs.

Funding

This study is self-funded.

Competing interest

All authors have no conflicts of interest or financial ties to disclose.

Generalizability

This is a single-center study; therefore, the generalizability of the results cannot be made.

Data Availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Acknowledgments:

We appreciate the children and parents' cooperation to take part in the study and their commitment to adhere to the study's guidelines.

Ethics declarations

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

The scientific approval for the study project was obtained from the scientific committee in the department of Pediatric and Preventive Dentistry, College of the Dentistry/University of Baghdad, additionally; the ethical approval (no. 576322) for the study was obtained on (2.6.2022) from the Central Committee of ethics in the College of Dentistry/University of Baghdad. The study was conducted in accordance with the ethical standards outlined in the 1964 Declaration of Helsinki and its subsequent amendments, or with comparable ethical standards

Author information

Authors and Affiliations

Duaa Kamal Naji: Master student, Department of Pedodontic and Preventive Dentistry, College of Dentistry, University of Baghdad. Bab-Almoadham, P.O. Box 1417, Baghdad /Iraq.

Zainab Juma Jafar. Assistant Professor, Department of Pedodontic and Preventive Dentistry, College of Dentistry, University of Baghdad. Bab-Almoadham, P.O. Box 1417, Baghdad, Iraq.

Bayda’a Ahmed Yas Assistant Professor, Department of Pediatric and Preventive Dentistry, Preventive dentistry, Urok dentistry ‎college ‎/Iraq

Corresponding author: Duaa Kamal Naji

[email protected]

Author contributions

Duaa Kamal Naji was responsible for performing research, providing research materials, resources, software gathering, and data arrangement, and drafting the article’s initial draft.

Zainab Juma Jafar was responsible for project management, supervision, validation, visualization, monitoring the research, drafting the article's final draft, and data curation, formal analysis, investigation, and logistical support.

Bayda’a Ahmed Yas developed and designed the study, the final draft of the paper was reviewed and approved by all authors, and each author is responsible for the content of the content as well as its similarity index.

Al-Nema ZM, Mohammed SI, Ahmed FT. Effect of Administration of Crystalloid IV Fluids Preoperatively on Postoperative Pain. Iraqi Journal of Pharmaceutical Sciences (P-ISSN: 1683-3597, E-ISSN: 2521-3512). 2012;21(1):34-8.
Sreenivas A, Raj AS, Puthenpurackal VR, Haneef T, Pillai GR, Jose D, SG G. Pain perception in different injection techniques in paediatric dentistry: an original research. European Journal of Molecular & Clinical Medicine. 2020;7(09):2020.
Jayakaran TG, Vignesh R, Shankar P. Local anesthetics in pediatric dental practice. Res J Pharm Technol. 2019 Aug 1;12:4066-70.
Jafar ZJ, Aldafaai RR. Effect of Nutritional Status on Dental Caries and Salivary Alkaline Phosphatase in a Group of Children. International Medical Journal. 2022 Feb 1;29(1):64-7.
Flisfisch S, Woelber JP, Walther W. Patient evaluations after local anesthesia with a computer-assisted method and a conventional syringe before and after reflection time: A prospective randomized controlled trial. Heliyon. 2021 Feb 1;7(2):e06012.
Rasha Khalaf Zighair, Zainab Juma Jafa, Evaluation the Effect of Multi-Coloured Versus Traditional Restorative Materialson the Children’s Dental Anxiety , J Res Med Dent Sci, 2020, 8(5): 173-177 .
Khaleel FM, Al-Shammari IA, Oda NN. The Effect of Anesthesia on Thyroid Hormones and Cortisol Levels Following Major Urological Surgery. Baghdad Science Journal. 2017;14(4).
El Tawil SB, El Dokky NA. Effect of Jet injection (INJEX) on pain perception among a group of pediatric dental patients. Egyptian Dental Journal. 2018 Jul 1;64(3-July (Orthodontics, Pediatric & Preventive Dentistry)):1933-9.
Moretti r, jepsen c, melamed b. Controlling anxiety in the dental office. Journal of the american dental association. 1986 Nov 1;113(5):728-35.
Marsac ML, Funk JB. Relationships among psychological functioning, dental anxiety, pain perception, and coping in children and adolescents. Journal of Dentistry for Children. 2008 Sep 15;75(3):243-51.
Van Wijk AJ, Hoogstraten J. Anxiety and pain during dental injections. Journal of dentistry. 2009 Sep 1;37(9):700-4.
Chengappa MD, Prashanth AK. Evaluation of efficacy of computer-controlled local anaesthetic delivery system vs traditional injection system for minor pediatric surgical procedures in children. Medical Journal Armed Forces India. 2020 Nov 2.
Numbee by BioDent. Anesthesia - we take the sting out of anesthesia. Available at: https://www.mynumbee.com
Chen H, Cohen P, Chen S. How big is a big odds ratio? Interpreting the magnitudes of odds ratios in epidemiological studies. Communications in Statistics—simulation and Computation®. 2010 Mar 31;39(4):860-4.
Ferguson, C. J. (2009). An effect size primer: A guide for clinicians and researchers. Professional Psychology: Research and Practice, 40, 532-538.
Rosnow RL, Rosenthal R. Statistical procedures and the justification of knowledge in psychological science.
Cohen J. Statistical power analysis for the social sciences (pp. 75–107).
Patra P. sample size in clinical research, the number we need. Int J Med Sci Public Health 2012;1:5-9.
Christensen C, Arnason SC, Oates R, Crabtree M, Kersey Jr JW, Vandewalle KS. Efficacy of Pulpal Anesthesia Using a Needle-less Syringe. Anesthesia Progress. 2020;67(4):200-6.
Wong DL, Hockenberry MJ, Wilson D, Winkelstein ML. Wong's essentials of pediatric nursing. Mosby; 2005.
Haghighat A, Jafari Z, Hasheminia D, Samandari MH, Safarian V, Davoudi A. Comparison of success rate and onset time of two different anesthesia techniques. Medicina oral, patologia oral y cirugia bucal. 2015 Jul;20(4):e459.
Tortamano IP, Siviero M, Lee S, Sampaio RM, Simone JL, Rocha RG. Onset and duration period of pulpal anesthesia of articaine and lidocaine in inferior alveolar nerve block. Brazilian Dental Journal. 2013 Jul;24:371-4.
Waikakul A, Punwutikorn J. A comparative study of the extra-intraoral landmark technique and the direct technique for inferior alveolar nerve block. Journal of oral and maxillofacial surgery. 1991 Aug 1;49(8):804-8
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. Anesthesia progress. 2010;57(1):3-12.
Tomlinson D, Von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98.
Schiavenato M, Byers J, Scovanner P, Windyga P, Shah M. Is there a primal face of pain? A methodology answer. In2007 29th Annual International Conference of the IEEE Engineering in Medicine and Biology Society 2007 Aug 22 (pp. 3559-3562). IEEE.

No competing interests reported.

Download PDF

Version 1

posted

You are reading this latest preprint version

NumBee versus Traditional Injection: A Comparison of Pain Perception and Efficiency (A Randomized, Split- Mouth Clinical Trail)

Status:

Version 1

Abstract

Figures

Introduction

Materials And Methods

Study design and participants

Setting

Sample Calculation And Randomization

Intervention

Ethical Consideration

Statistical analysis

Results

PR=Positive rank, NR=Negative rank, A=Numbee< IANB, B=Numbee> IANB, c=injection cavity

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

Version 1