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ORIGINAL ARTICLE
Year : 2015  |  Volume : 33  |  Issue : 4  |  Page : 285-290
 

Effectiveness of lidocaine Denti patch ® system versus lidocaine gel as topical anesthetic agent in children


Department of Preventive Dental Sciences, Al Farabi College of Dentistry, Riyadh, Kingdom of Saudi Arabia

Date of Web Publication18-Sep-2015

Correspondence Address:
Dr. Bahija Basheer
Department of Preventive Dental Sciences, Al Farabi College of Dentistry, Riyadh
Kingdom of Saudi Arabia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0970-4388.165664

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   Abstract 

Background: New methods have been introduced to facilitate dental procedures, but the administration of local anesthesia is still necessary to perform pain control during several dental procedures. Aim: To evaluate the effectiveness of the lidocaine Denti-patch ® system versus the lidocaine topical anesthetic gel in children concerning pain reaction during injection. Materials and Methods: One hundred 9-12-year-old cooperative children weighing more than 29 kg in need of bilateral dental treatment requiring maxillary and mandibular injection and not suffering from acute pain as a result of pulpits on the day of treatment were selected. The children were then divided into two groups: Group 1 comprising of 50 children in need of bilateral maxillary treatment and Group 2 compromising of 50 children requiring bilateral mandibular treatment. These groups were further subdivided into subgroups A and B; those receiving Denti-patch ® on one side and lidocaine gel on the contralateral side, respectively. Pain or comfort was evaluated during injection using sound, eye, motor (SEM) scale (objective method) while, using faces pain rating scale (FPS) scale (subjective method) after injection by a trained assistant blinded to the procedure. Statistical Analysis Used: Comparison of the results was performed using Mann-Whitney U-test and Wilcoxon signed-ranks test for SEM and FPS score. Result: There was a statistically significant difference between the patch and the gel group for maxilla (P < 0.0001), as well as mandible (P = 0.01) with respect to SEM score given by the children. Similarly, with FPS scale, there was a statistically significant difference between the patch and the gel groups in both maxilla and mandible (P < 0.0001). However, there was no statistical difference between the patch Groups 1A and IIA or the gel Groups 1B and II B. Conclusion: The Denti-patch ® system can significantly reduce the needle injection pain more than the gel.


Keywords: Children, Denti-patch ® system, topical anesthesia delivery system alternative


How to cite this article:
Shehab LA, Basheer B, Baroudi K. Effectiveness of lidocaine Denti patch ® system versus lidocaine gel as topical anesthetic agent in children. J Indian Soc Pedod Prev Dent 2015;33:285-90

How to cite this URL:
Shehab LA, Basheer B, Baroudi K. Effectiveness of lidocaine Denti patch ® system versus lidocaine gel as topical anesthetic agent in children. J Indian Soc Pedod Prev Dent [serial online] 2015 [cited 2019 Jul 15];33:285-90. Available from: http://www.jisppd.com/text.asp?2015/33/4/285/165664



   Introduction Top


Pain is a highly complex and multidimensional defense mechanism that alerts the organism regardless of real or apparent tissue damage, to take action in relieving the presence of a potential stimulus. [1] In pediatric dentistry, it is important to acknowledge that the pain sensation is not necessarily dependant on tissue damage; it may also be generated by condition stimuli such as sound of the drill or of the touch of the needle during local anesthetic injections.

Anxiety is one of the major issues hindering the quality of dental treatment in children, and the injection is most anxiety-provoking procedure. [2],[3],[4] Henceforth, there is a need to find more comfortable and pleasant delivery systems for local anesthesia in children.

The dentist must possess certain knowledge, readiness, and skill for the administration of painless anesthesia. There are two important aspects in this context; the first is behavior modification through apt communication and the second is a technical procedure in order to ensure a nontraumatic experience for the child. [4]

Topical anesthesia is a fundamental part of local anesthesia administration as it has both psychological and pharmacological impact. Topical anesthetics control pain perception and hence, alter the reaction to pain by blocking the transmission of signals from the terminal fibers of the sensory nerves. Their effects are limited to the control of painful stimuli occurring on or just beneath the mucosa. [5],[6]

The application of topical anesthetic can reduce the discomfort of intraoral anesthetic injections; provide anesthesia for intraoral operative procedures, provide symptomatic relief of pain due to superficial mucosal lesions such as ulcers or even relieve toothache and postextraction pain. Topical anesthetics are available as ointments, gels, sprays or even as an adhesive patch. [5],[6],[7],[8]

The Denti-patch ® system

Beginning in 1990, Noven Pharmaceuticals, a developer and manufacturer of transdermal products, set out to develop a transmucosal delivery system for preinjection numbing so as to address the shared desire of patients and dentists for a better, less painful approach. [9]

Ideally, the product would block the injection pain and in case of less invasive procedures, actually eliminate the need for an injection altogether as this system can provide pain relief "to the bone" owing to rapid onset of <15 min after patch application and moderate duration of action of <30 min after removal. [9]

The Denti-patch ® (Noven Pharmaceuticals Inc., USP IV) is a small (2 cm) patch that adheres to the gum line, available in 20% concentration containing 46.1 mg of lidocaine base. It was approved by the US Food and Drug Administration in 1996 and has been used successfully throughout the United States to ease the pain of the injections and to permit certain procedures without the use of a needle. It penetrates deeper and last longer than conventional topical numbing gels. The effect of the Denti-patch lasts for up to 45 min while that of the conventional topical gels only last for 1 min. [9]

This new topical anesthetic delivery system (The Denti-patch ® , Noven Pharmaceuticals Inc.,) may prove highly useful in allaying the anxiety of children toward selected dental procedures and especially to needle injections. [10]

The purpose of this study was to evaluate the effectiveness of the lidocaine Denti-patch versus the lidocaine topical anesthetic gel in children concerning pain reaction during local anesthesia administration.


   Materials and Methods Top


The study was conducted on hundred 9-12-year-old children attending the Department of Pediatric Dentistry for bilateral dental treatment requiring maxillary or mandibular injections. Ethical clearance and parent consent were obtained prior to the study. The subjects who weighed <29 kg, those suffering from any systemic diseases, or having acute pain on the day of treatment were excluded from the study.

The selected children were then divided into two groups: Group 1 comprising of 50 children in need of bilateral maxillary treatment and Group 2 compromising of 50 children requiring bilateral mandibular treatment. A random crossover design was used so that each child served as their own controls and was further subdivided into subgroups A and B; those receiving Denti-patch ® (Noven Pharmaceuticals Inc.,) on one side and those receiving lidocaine gel on the contralateral side, respectively. Those who received lidocaine gel in the first visit was administered Denti-patch ® in the second visit and vice versa.

Following case history and clinical examination, bilateral periapical radiographs were taken, and the procedure was explained to the parents. After isolating with cotton rolls and suction, the injection site was dried using 2" × 2" sterile gauze.

Procedures for Denti-patch application

The Denti-patch ® (Noven Pharmaceuticals Inc., USP IV) was shown to the child after removing the protective liner and applied using firm pressure to the site after informing them that it will put their tooth to sleep. The patch was left undisturbed for 5 min and then removed for local anesthetic injection. The local anesthetic Mepicain L ® (The Alex Co., for Pharmaceuticals and chemicals) - Mepivacaine HCl 2% with levonordefrin 1: 20,000) was deposited slowly (1 mL/min) using a 27" gauge needle (unilock, dispovan) at the operative site and the dental treatment was carried out whether restoration, pulpotomy or extraction as required.

In the second visit, after isolation lidocaine gel, Topicaine ® (4% Lidocaine, AstraZeneca LP, Dentsply Pharmaceuticals, NY) was applied to the injection site using sterile cotton dipped applicator and left for 5-10 min after informing the child. The local anesthetic was injected as described earlier at the contralateral site and preceded with the necessary treatment.

For restorative treatments, buccal infiltration was given to maxillary arch and inferior alveolar nerve block for the mandibular arch. In extraction cases, buccal and palatal infiltration were given for maxillary arch whereas inferior alveolar block and buccal infiltration for the mandibular arch.

Because pain is extremely difficult to quantify in young children, two different scales were used to assess pain:

  1. The sound, eye, motor (SEM) scale which is an objective scale was used to measure pain or comfort, taking into account SEM components of the child's response to stimulation [Table 1]. An assistant was trained on measuring and calibrating of the SEM scale but was blinded from the technique used to avoid bias. [11],[12]
    Table 1: SEM scale


    Click here to view
  2. The second scale was Wong-Baker faces pain rating scale (FPS), which is a subjective scale to assess pain perception. The child was shown a set of six cartoon faces with varying facial expressions ranging from a very smiling face to a very sad face [Figure 1]. A brief explanation was given to the child about each face after which the child was asked to choose the face that best described his/her feelings while receiving local anesthesia. [13],[14]
Figure 1: Wong-Baker face scale (faces pain rating scale)


Click here to view


Statistical analysis

Comparison of SEM scale and FPS scale scores between different subgroups (gel and patch) was done using Wilcoxon signed-ranks test while comparison between groups in different patients (maxilla and mandible) was done using Mann-Whitney U-test. The significant level was set as 5% level.


   Results Top


There was a statistically significant difference between the patch and the gel group for the maxilla (P < 0.0001), as well as the mandible (P = 0.01) with respect to SEM score given by the children. Similarly, with FPS scale, there was a statistically significant difference between the patch and the gel groups in both maxilla and mandible (P < 0.0001) [Table 2].
Table 2: Comparison of the SEM scale and FPS scale between maxilla and mandible groups using Mann-Whitney U-test


Click here to view


However, there was no statistical difference between the patch Groups 1A and IIA or the gel Groups 1B and II B [Table 3].
Table 3: Comparison between the subgroups (patch and gel ) as regards to SEM and FPS scores using Wilcoxon signed-rank test


Click here to view



   Discussion Top


New methods have been introduced to facilitate dental procedures, but the administration of local anesthetic is still necessary to perform pain control during several dental procedures. The thought and performance of local anesthetic injection often provoke feelings of discomfort for the patient and have been described as one of the most anxiety-provoking procedures in dentistry. [15],[16] Therefore, any procedure that significantly reduces the unpleasantness of dental injection could serve as a positive reinforce toward obtaining dental care.

Topical anesthetics was used in dentistry are frequently used in dentistry in order to reduce or eliminate pain during an injection procedure. Therefore, the present study was conducted to evaluate the effectiveness of two lidocaine based delivery systems-the lidocaine Denti-patch ® versus the lidocaine topical anesthetic gel in children concerning pain reaction during injection.

The topical anesthetic gels that are frequently used lack bio adhesiveness to the oral mucosa, making them relatively ineffective. Therefore, the Denti-patch system was used to overcome this problem and ensure contact with the oral mucosa.

The present study consisted of 100 children with an age range from 9 to 12 years. This age was selected to ensure body weight more than 29 kg, which realize safety for the children. On using 2 patches in case of maxillary extraction (46.1 mg lidocaine each) with the administration of local anesthesia (36 mg mepivacaine) the total concentration of anesthesia will be 128.2 mg. The maximum dose of both lidocaine and mepivacaine is 4.4 mg/kg in children, so the weight of the body child must be (128.2/4.4 = 29.13 kg). Also, children of this age range would possess sufficient verbal and cognitive skills to communicate well and understand the instructions and explanation given about the treatment.

It is clinically important to note that uncooperative children can give inaccurate pain assessment, all the children selected for this study were cooperative (positive or definitely positive according to the Frankel's Behavior rating scale. In order to ensure an accurate comparison between the two topical anesthetic systems, the Denti-patch ® (Noven Pharmaceuticals Inc.,) and the lidocaine gel was used in each child bilaterally prior to the dental procedure.

Since, pain is extremely difficult to quantify in children, two different scales (subjective and objective) were used to assess pain. The SEM scale used is an objective study that measures pain or discomfort taking into account the SEM components of child's response to stimulation. Moreover, this scale has a 90% inter-rater reliability. The subjective scale used was FPS scale which measures the degree of unpleasantness or effective dimension of child's pain experience especially in children aged from 3 to 17 years. According to Lindsay et al., the FPS scale has been translated to over 30 languages and showed good construct validity as self-report pain measure. [11]

In the present study, children were more comfortable to the injection following Denti-patch application than lidocaine gel. This positive effect towards reducing pain could be attributed to the dimensions of the patch which facilitated better adaptation allowing perfect bioadhesiveness and better diffusion thereby sufficient anesthetic effect. This finding was in accordance with those of Hersh et al., [17] Taware et al., [18] Carr and Horton [19] and Bågesund and Tabrizi [20] who found that Denti-patch was preferred over gel by children due to reduced pain while receiving local anesthesia due to the earlier onset of anesthesia and better penetration of the gel. However, Kreider et al. [21] and Wu and Julliard [22] found that the Denti-patch and the benzocaine gel seem to provide similar pain reduction at needle stick and injection of local anesthesia.

On comparing the effect of the two topical anesthetic systems between maxilla and mandible; both scales (SEM and FPS) showed the better anesthetic effect on maxilla than the mandible. A possible explanation could be the poor adherence of the Denti-patch ® (Noven Pharmaceuticals Inc.,) system in the mandible observed in 5% of the studied children. This finding was in accordance to that of Hersh et al., [17] Carr and Horton [19] and Stecker et al. [23] who reported Denti-patch ® (Noven Pharmaceuticals Inc.,) to be more effective than gel in reducing needle stick discomfort in mandible and could be attributed to the higher salivary flow in mandible than in maxilla.

There were no statistical significant differences between age, sex and both arches regarding their effect on the pain scores for SEM and FPS scales which supported the findings of Robinson et al. [24] and Carr and Horton [25] who found no significant differences in the pain scores between the sexes and for maxilla and mandible. The reason could be that the Denti-patch and the lidocaine gel were applied to the keratinized tissue, and the gingival tissues were equally anesthetized.

In general, the Denti-patch ® (Noven Pharmaceuticals Inc.,) system proved to promote relatively less painful injections than lidocaine gel for many reasons, viz.; the superior duration of contact to the oral tissues than gel due to the enclosure of the lidocaine base in a bioadhesive patch; better taste than gel and more effective and reliable technique.


   Conclusion Top


The Denti-patch ® (Noven Pharmaceuticals Inc.,) was perceived to be significantly more effective than the lidocaine gel. It had a positive effect on reducing pain reaction during injection. The Denti-patch ® system proved to be a more efficient and reliable technique to achieve topical anesthesia and thereby reduce pain and improve patient behavior in subsequent visits in pediatric dentistry. However, further studies are needed to evaluate the effect of increased application time and the systemic blood levels achieved by Denti-patch ® so that it can prove to be an alternative to conventional syringe injection.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

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Savino F, Vagliano L, Ceratto S, Viviani F, Miniero R, Ricceri F. Pain assessment in children undergoing venipuncture: The Wong-Baker faces scale versus skin conductance fluctuations. PeerJ 2013;1:e37.  Back to cited text no. 12
    
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  [Table 1], [Table 2], [Table 3]



 

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