NCT03779659

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Fear
• Anesthesia, Local
• Pediatric Dentistry

Interventions

Type	Name	Description
DEVICE	Synapse TENS 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.
DRUG	Topical anesthetic gel	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

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-12-01
• Completion: 2023-02-01
• First posted: 2018-12-19
• Last updated: 2021-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study