Effectiveness of Transcutaneous Electronic Nerve Stimulation (TENS) During Dental Procedures Among Children
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 6 - 12 |
| Updated: | 2/14/2019 |
| Start Date: | April 2019 |
| End Date: | June 2022 |
| Contact: | Jayapriyaa Shanmugham, BDS DrPH |
| Email: | jshanmug@bu.edu |
| Phone: | 617-358-4447 |
Effectiveness of Transcutaneous Electronic Nerve Stimulation (TENS) Device in Reducing Pain Among Children 6-12 Years Receiving Local Anesthetic Injection During Dental Treatments in a Randomized Cross-over Clinical Trial
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 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 6-12 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.
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 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 6-12 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.
Children between 6-12 years will be recruited at the Pediatric Oral Healthcare Center. A
sample of 50 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
(Group A) of the comparison group (Group B). Group A receives the experimental device (TENS)
prior to local anesthetic injection whereas group B 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 (Group B) will receive the experimental device (Group C) in visit 2 and those who
received the experimental device (Group A) in visit 1 will receive the local anesthetic gel
in visit 2 (Group D). Following this treatment procedures are completed.
Group A (n = 25): Random allocation of participants to receive TENS device prior to local
anesthetic injection for the first procedure.
Group B (n = 25): Random allocation of participants to receive local anesthetic gel prior to
local anesthetic injection for the first procedure.
Group C (n = 25): Subjects who received local anesthetic gel prior to local anesthetic
injection.
at first appointment will be assigned to this group to receive TENS device with local
anesthetic injection in the second appointment.
Group D (n = 25): Subjects who received the TENS device with local anesthetic injection at
first appointment will be assigned to this group to receive the local anesthetic gel prior to
local anesthetic injection in the second appointment.
sample of 50 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
(Group A) of the comparison group (Group B). Group A receives the experimental device (TENS)
prior to local anesthetic injection whereas group B 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 (Group B) will receive the experimental device (Group C) in visit 2 and those who
received the experimental device (Group A) in visit 1 will receive the local anesthetic gel
in visit 2 (Group D). Following this treatment procedures are completed.
Group A (n = 25): Random allocation of participants to receive TENS device prior to local
anesthetic injection for the first procedure.
Group B (n = 25): Random allocation of participants to receive local anesthetic gel prior to
local anesthetic injection for the first procedure.
Group C (n = 25): Subjects who received local anesthetic gel prior to local anesthetic
injection.
at first appointment will be assigned to this group to receive TENS device with local
anesthetic injection in the second appointment.
Group D (n = 25): Subjects who received the TENS device with local anesthetic injection at
first appointment will be assigned to this group to receive the local anesthetic gel prior to
local anesthetic injection in the second appointment.
Inclusion Criteria:
- Children male and female aged 6-12 years
- 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. Participants will be notified
that these two procedures will be done in two separate appointments or procedures
- Children who are scheduled to attend two 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
- Children who have major medical problems
- Children taking medications for major medical illnesses
- Children who have pacemakers
- Children with disabilities or who require special attention during clinical procedures
We found this trial at
1
site
100 East Newton Street
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Phone: 617-358-4447
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