Clinical trial NCT03779659: Effectiveness of Synapse Transcutaneous Electronic Nerve Stimulation (TENS) During Dental Procedures Among Children
Official title: Effectiveness of Synapse Transcutaneous Electronic Nerve Stimulation (TENS) Device in Reducing Pain Among Children 6-14 Years During Dental Treatments in a Randomized Cross-over Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dental Fear
Anesthesia, Local
Pediatric Dentistry
Keywords: Electronic dental anesthesia
Transcutaneous Electronic Nerve Stimulation (TENS)
Topical anesthesia
Analgesia
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Dental Fear and Anxiety (DFA) are at higher levels among children and often leads to avoidance of dental treatment. Negative experiences in the early years such as experience of pain during injections, fillings, or extractions may lead to difficulties in treatment and behavior management among children. During dental procedures such as restorations and extractions injectable anesthetics are required as they are used to anesthetize and numb the area around the tooth receiving treatment. Topical anesthetics are used prior to using injectable anesthetic to alleviate some pain and discomfort. Topical anesthetics should be used with caution as they consist of more concentrated doses of pharmaceutical elements used in injectable anesthetics. Such high concentrations can result in increased gag reflux, central nervous system depression and cardiovascular effects in rare cases. With many recent advances in dental treatment, there is also a need for new non-pharmaceutical strategies to alleviate pain and discomfort among children which in turn will motivate children and their parents to visit the dental clinic more frequently. Electronic anesthesia or Synapse Transcutaneous Electronic Nerve Stimulation (TENS), a non-invasive device that uses low energy electrical stimulation to reduce pain perception, has gained acceptance since the 1990s. Advantages of using the TENS device are that it is safe, easy to use, well-accepted among patients as evidenced in the few trials conducted so far, no adverse complications and has been successful in alleviating pain during dental procedures. This study aims to explore use of the TENS to alleviate pain and discomfort at the oral mucosal site where the patient will receive a local anesthetic injection. In this randomized case-crossover trial among children aged 6-14 years the effectiveness of Aleve TENS device in reducing pain and anxiety among children prior to receiving injectable local anesthetic agent during dental procedures is compared to those who receive the local anesthetic gel prior to receiving local anesthetic injection.

Detailed description: Children between 6-14 years will be recruited at the Pediatric Oral Healthcare Center. A sample of 100 male and female children who fit the inclusion and exclusion criteria are recruited. Once parents' consent at the first visit basic demographic information, dental and medical history information is collected. This study is conducted in total of two clinic visits. In the first visit participants are randomized to either the intervention group or the comparison group. The intervention group receives the experimental device (TENS) prior to local anesthetic injection whereas the comparison group receives the local anesthetic gel. Following this the participants receive the local anesthetic injection after which treatment is completed. In the second visit the participants are crossed over to the other group and therefore randomization is not used for visit 2. Those who received the local anesthetic gel in visit 1 will receive the experimental device in visit 2 and those who received the experimental device in visit 1 will receive the local anesthetic gel in visit 2 . Following this treatment procedures are completed.

Eligibility criteria: Inclusion Criteria:

* Children who are healthy and without any major medical conditions
* Children who are patients at the Pediatric Oral Healthcare Center
* Children requiring restoration on the occlusal surface that involves tooth preparation up to the dentin level in at least two primary or permanent molars or children requiring extractions of primary or permanent molars.
* Children who are scheduled for at least two appointments and who require two restorative procedures or two extractions than can be scheduled over two separate appointments

Exclusion Criteria:

* Children who have contraindications to local anesthetic
* Children with teeth requiring restoration and have pulp involvement and root resorption on radiological examination (i.e. deep caries)
* Children who have major medical problems
* Children taking medications for major medical illnesses
* Children who have pacemakers
* Children with ADD/ADHD, autism or Down's syndrome and children with a history of behavioral issues that required previous management.

Primary outcomes:
measure: Presence of Pain before treatment
timeFrame: before the start of each treatment procedure up to 6 months
measure: Presence of Pain before local analgesic injection
timeFrame: after TENS or gel administration before local analgesic injection at about 1 minute
measure: Presence of Pain after treatment
timeFrame: about 45 minutes at the end of the treatment visit
measure: Level of pain before treatment based on Wong-Baker Faces (WBF) pain rating scale
timeFrame: before the start of each treatment procedure up to 6 months
measure: Level of pain before local analgesic injection based on Wong-Baker Faces (WBF) pain rating scale
timeFrame: after TENS or gel administration before local analgesic injection at about 1 minute
measure: Level of pain after treatment based on Wong-Baker Faces (WBF) pain rating scale
timeFrame: about 45 minutes at the end of the treatment visit
measure: Level of dental anxiety before treatment using Visual Analog Scale
timeFrame: before the start of each treatment procedure up to 6 months
measure: Level of dental anxiety before local analgesic injection using Visual Analog Scale
timeFrame: after TENS or gel administration before local analgesic injection at about 1 minute
measure: Level of dental anxiety after treatment using Visual Analog Scale
timeFrame: about 45 minutes at the end of the treatment visit
Secondary outcomes:
measure: Patient's comfort level preference
timeFrame: up to 6 months
measure: Treatment completion status
timeFrame: up to 6 months
measure: Reason for partially completed treatment
timeFrame: up to 6 months
measure: Supplemental anesthetic use
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: BU Henry M. Goldman School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Department of Pediatric Dentistry, Henry M. Goldman School of Dental Medicine
name: Jayapriyaa Shanmugham, BDS DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington DC, American Psychiatric Press. 1994.
citation: Alvesalo I, Murtomaa H, Milgrom P, Honkanen A, Karjalainen M, Tay KM. The Dental Fear Survey Schedule: a study with Finnish children. Int J Paediatr Dent. 1993 Dec;3(4):193-8. doi: 10.1111/j.1365-263x.1993.tb00083.x.
citation: Shim YS, Kim AH, Jeon EY, An SY. Dental fear & anxiety and dental pain in children and adolescents; a systemic review. J Dent Anesth Pain Med. 2015 Jun;15(2):53-61. doi: 10.17245/jdapm.2015.15.2.53. Epub 2015 Jun 30.
citation: Cianetti S, Lombardo G, Lupatelli E, Pagano S, Abraha I, Montedori A, Caruso S, Gatto R, De Giorgio S, Salvato R. Dental fear/anxiety among children and adolescents. A systematic review. Eur J Paediatr Dent. 2017 Jun;18(2):121-130. doi: 10.23804/ejpd.2017.18.02.07.
citation: Ogle OE, Mahjoubi G. Local anesthesia: agents, techniques, and complications. Dent Clin North Am. 2012 Jan;56(1):133-48, ix. doi: 10.1016/j.cden.2011.08.003.
citation: Armfield JM, Milgrom P. A clinician guide to patients afraid of dental injections and numbness. SAAD Dig. 2011 Jan;27:33-9.
citation: Lee HS. Recent advances in topical anesthesia. J Dent Anesth Pain Med. 2016 Dec;16(4):237-244. doi: 10.17245/jdapm.2016.16.4.237. Epub 2016 Dec 31.
citation: Boyce RA, Kirpalani T, Mohan N. Updates of Topical and Local Anesthesia Agents. Dent Clin North Am. 2016 Apr;60(2):445-71. doi: 10.1016/j.cden.2015.12.001.
citation: Yap AU, Ho HC. Electronic and local anesthesia: a clinical comparison for operative procedures. Quintessence Int. 1996 Aug;27(8):549-53.
citation: Abdulhameed SM, Feigal RJ, Rudney JD, Kajander KC. Effect of peripheral electrical stimulation on measures of tooth pain threshold and oral soft tissue comfort in children. Anesth Prog. 1989 Mar-Apr;36(2):52-7.
citation: teDuits E, Goepferd S, Donly K, Pinkham J, Jakobsen J. The effectiveness of electronic dental anesthesia in children. Pediatr Dent. 1993 May-Jun;15(3):191-6.
citation: Cho SY, Drummond BK, Anderson MH, Williams S. Effectiveness of electronic dental anesthesia for restorative care in children. Pediatr Dent. 1998 Mar-Apr;20(2):105-11.
citation: Baghdadi ZD. Evaluation of electronic dental anesthesia in children. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Oct;88(4):418-23. doi: 10.1016/s1079-2104(99)70055-7.
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.
citation: Dhindsa A, Pandit IK, Srivastava N, Gugnani N. Comparative evaluation of the effectiveness of electronic dental anesthesia with 2% lignocaine in various minor pediatric dental procedures: A clinical study. Contemp Clin Dent. 2011 Jan;2(1):27-30. doi: 10.4103/0976-237X.79305.