Effectiveness of Synapse Transcutaneous Electronic Nerve Stimulation (TENS) During Dental Procedures Among Children
Status:
Withdrawn
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
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.