Effectiveness of Synapse Transcutaneous Electronic Nerve Stimulation (TENS) During Dental Procedures Among Children

NCT03779659 | Withdrawn DMC FDA Device

• 1 other identifier: H-37546
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Fear; Anesthesia, Local; Pediatric Dentistry

Keywords

Electronic dental anesthesia; Transcutaneous Electronic Nerve Stimulation (TENS); Topical anesthesia; Analgesia

Outcome Measures

Primary Outcomes (9)

• Presence of Pain before treatment

  The presence of pain will be a simple question in the case report form with two answer choices: yes or no.

  before the start of each treatment procedure up to 6 months

• Presence of Pain before local analgesic injection

  The presence of pain will be a simple question in the case report form with two answer choices: yes or no.

  after TENS or gel administration before local analgesic injection at about 1 minute

• Presence of Pain after treatment

  The presence of pain will be a simple question in the case report form with two answer choices: yes or no.

  about 45 minutes at the end of the treatment visit

• Level of pain before treatment based on Wong-Baker Faces (WBF) pain rating scale

  Level of pain will be measured using the Wong-Baker Faces (WBF) pain rating scale. The scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value from 0 to 5, with higher values indicating more pain. Based on child's selection of the facial expression a score will be assigned.

  before the start of each treatment procedure up to 6 months

• Level of pain before local analgesic injection based on Wong-Baker Faces (WBF) pain rating scale

  Level of pain will be measured using the Wong-Baker Faces (WBF) pain rating scale. The scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value from 0 to 5, with higher values indicating more pain. Based on child's selection of the facial expression a score will be assigned.

  after TENS or gel administration before local analgesic injection at about 1 minute

• Level of pain after treatment based on Wong-Baker Faces (WBF) pain rating scale

  Level of pain will be measured using the Wong-Baker Faces (WBF) pain rating scale. The scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value from 0 to 5, with higher values indicating more pain. Based on child's selection of the facial expression a score will be assigned.

  about 45 minutes at the end of the treatment visit

• Level of dental anxiety before treatment using Visual Analog Scale

  Level of anxiety will be measured using the Visual Analog Scale. The scale is a simple line with the number line ranging from 0 to 10. Children are asked how nervous or confident they feel and are asked to point or mark on the line. The corresponding numerical value will be noted for each patient.

  before the start of each treatment procedure up to 6 months

• Level of dental anxiety before local analgesic injection using Visual Analog Scale

  Level of anxiety will be measured using the Visual Analog Scale. The scale is a simple line with the number line ranging from 0 to 10. Children are asked how nervous or confident they feel and are asked to point or mark on the line. The corresponding numerical value will be noted for each patient.

  after TENS or gel administration before local analgesic injection at about 1 minute

• Level of dental anxiety after treatment using Visual Analog Scale

  Level of anxiety will be measured using the Visual Analog Scale. The scale is a simple line with the number line ranging from 0 to 10. Children are asked how nervous or confident they feel and are asked to point or mark on the line. The corresponding numerical value will be noted for each patient.

  about 45 minutes at the end of the treatment visit

Secondary Outcomes (4)

• Patient's comfort level preference

  up to 6 months

• Treatment completion status

  up to 6 months

• Reason for partially completed treatment

  up to 6 months

• Supplemental anesthetic use

  up to 6 months

Study Arms (2)

Synapse TENS device

EXPERIMENTAL

SYnapse TENS device will be used for alleviating pain through electrical stimulation. This is a battery powered device where an electrical current is applied intra-orally on the buccal and lingual sides using an intra-oral pad applicator. This device has been cleared for marketing by the Food and Drug Administration (FDA) and the prescribed electrical field falls almost a 10 factor level lower than routine pulp testing devices used in dentistry. The TENS device was previously tested in a pilot study with promising results. Chair side application and at-home use of the device by the patient was shown to drastically reduce pain and discomfort associated with orthodontic tooth movement.

Device: Synapse TENS device

Topical anesthetic gel

ACTIVE COMPARATOR

Topical anesthetic Gel is the active comparator in this study. The topical anesthesia (anesthetic gel) Centrix LolliCaine with 20% benzocaine in single package of 0.3 ml will be used. The amount of local anesthetic used will not exceed the maximum allowable dose, which will be calculated for each patient based on his/her age and weight prior to the dental procedure. This will be done based American Association of Pediatric Dentistry guidelines for the use of local anesthesia.

Drug: Topical anesthetic gel

Interventions

Synapse TENS device DEVICE

At the time of local anesthetic application the TENS device will be activated and placed on the buccal and lingual alveolar mucosa adjacent to the tooth receiving the restorative treatment using the pad applicator. The tip of the device with the electrodes are placed in a vertical up and down motion for approximately ten seconds. Following this, the level of pain and anxiety are measured using the Wong Baker Scale and Visual Analog Scale. The TENS device is used for achieving localized pain relief at the site of local anesthetic injection prior to injecting the anesthetic agent (such as lidocaine or articaine). Following this, once the clinician ensures that the patient is pain free then local anesthetic injection is given and following that the dental procedures are conducted.

Also known as: ALEVE therapy

Synapse TENS device

Topical anesthetic gel DRUG

The local anesthetic gel is typically used for achieving localized pain relief at the site of local anesthetic injection and this is part of standard care that is followed prior to dental procedures. The amount of local anesthetic used will not exceed the maximum allowable dose, which will be calculated for each patient based on his/her age and weight prior to the dental procedure

Also known as: Centrix LolliCaine 2% xylocaine with 20% benzocaine

Topical anesthetic gel

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

BU Henry M. Goldman School of Dental Medicine

Boston, Massachusetts, 02118, United States

Location

Related Publications (15)

• American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington DC, American Psychiatric Press. 1994.

  BACKGROUND

• 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.

  PMID: 8142322 BACKGROUND

• 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.

  PMID: 28879259 BACKGROUND

• 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.

  PMID: 28598183 BACKGROUND

• 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.

  PMID: 22117947 BACKGROUND

• Armfield JM, Milgrom P. A clinician guide to patients afraid of dental injections and numbness. SAAD Dig. 2011 Jan;27:33-9.

  PMID: 21323034 BACKGROUND

• 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.

  PMID: 28879311 BACKGROUND

• 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.

  PMID: 27040295 BACKGROUND

• Yap AU, Ho HC. Electronic and local anesthesia: a clinical comparison for operative procedures. Quintessence Int. 1996 Aug;27(8):549-53.

  PMID: 9161258 BACKGROUND

• 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.

  PMID: 2604057 BACKGROUND

• 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.

  PMID: 8378157 BACKGROUND

• 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.

  PMID: 9566014 BACKGROUND

• 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.

  PMID: 10519748 BACKGROUND

• 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.

  PMID: 9477875 BACKGROUND

• 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.

  PMID: 22114450 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine; Benzocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jayapriyaa Shanmugham, BDS DrPH

  Department of Pediatric Dentistry, Henry M. Goldman School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 19, 2018
• Study Start: July 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Once data collection is complete and data analysis has been completed the results will be made available.
• Access Criteria: Since this is a pilot study only summary data will be provided.

Locations

US (1)