Dental FearNCT03779659
Effectiveness of Synapse Transcutaneous Electronic Nerve Stimulation (TENS) During Dental Procedures Among Children
A study testing Synapse TENS device and Topical anesthetic gel in people with Dental Fear and Anesthesia, Local, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Fear, Anesthesia, Local, Pediatric Dentistry
- What is being tested?
- Synapse TENS device and Topical anesthetic gel
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2021to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
BU Henry M. Goldman School of Dental Medicine
Boston, Massachusetts, 02118
About this study
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
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.
Read the 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
- Being tested
- Synapse TENS device, Topical anesthetic gel
- Keywords
- Electronic dental anesthesia, Transcutaneous Electronic Nerve Stimulation (TENS), Topical anesthesia, Analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synapse TENS deviceDevice
Also called ALEVE therapy
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.
Topical anesthetic gelDrug
Also called Centrix LolliCaine 2% xylocaine with 20% benzocaine
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Topical anesthetic gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: about 45 minutes at the end of the treatment visit
Secondary outcomes (4)
Patient's comfort level preference
The comfort or preference level for TENS device versus local anesthetic gel prior to local anesthetic injection will be assessed by asking the participants about their preference using a question in the case report form with five answer choices (using Likert scale - Very uncomfortable, somewhat uncomfortable, neither comfortable nor uncomfortable, somewhat comfortable, very comfortable)..
Measured: up to 6 months
Treatment completion status
Treatment completion status will be recorded as 'completed' or 'partially completed' on the Case Report Form at the conclusion of each treatment visit.
Measured: up to 6 months
Reason for partially completed treatment
For participants that do not complete both treatment procedures and are categorized as 'incomplete', the reason/s why will be documented.
Measured: up to 6 months
Supplemental anesthetic use
Amount of supplemental anesthesia if used for each of the two treatment procedures will be recorded in clinic notes after each treatment procedure.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study startJul 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Why it stopped: Prior to IRB submission, Covid-19 related logistical and personnel issues led to the decision to not move forward with this research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Dental FearStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayapriyaa Shanmugham, BDS DrPH, Principal investigator, Department of Pediatric Dentistry, Henry M. Goldman School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779659
- Sponsor's protocol ID
- H-37546
- Status last verified
- Jun 2021
- First submitted
- 13 Dec 2018
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Overall findings and summary of results for primary and secondary outcome measures will be made available.
Publications
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington DC, American Psychiatric Press. 1994.
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.
PubMed 8142322Shim 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.
PubMed 28879259Cianetti 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.
PubMed 28598183Ogle 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.
PubMed 22117947Armfield JM, Milgrom P. A clinician guide to patients afraid of dental injections and numbness. SAAD Dig. 2011 Jan;27:33-9.
PubMed 21323034Lee 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.
PubMed 28879311Boyce 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.
PubMed 27040295Yap AU, Ho HC. Electronic and local anesthesia: a clinical comparison for operative procedures. Quintessence Int. 1996 Aug;27(8):549-53.
PubMed 9161258Abdulhameed 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.
PubMed 2604057teDuits 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.
PubMed 8378157Cho 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.
PubMed 9566014Baghdadi 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.
PubMed 10519748Oztas 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.
PubMed 9477875Dhindsa 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.
PubMed 22114450
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03779659
- Acronym / sponsor ID
- H-37546
- Conditions
- Dental Fear, Anesthesia, Local, Pediatric Dentistry
- Keywords
- Electronic dental anesthesia, Transcutaneous Electronic Nerve Stimulation (TENS), Topical anesthesia, Analgesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Prior to IRB submission, Covid-19 related logistical and personnel issues led to the decision to not move forward with this research.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synapse TENS device | Experimental | Device: Synapse TENS deviceSYnapse 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. |
| Topical anesthetic gel | Active comparator | Drug: Topical anesthetic gelTopical 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. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synapse TENS deviceAlso: ALEVE therapyAt 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. | Device | Synapse TENS device |
| Topical anesthetic gelAlso: Centrix LolliCaine 2% xylocaine with 20% benzocaineThe 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 | Drug | Topical anesthetic gel |
Primary outcome
Presence of Pain before treatment
Time frame: before the start of each treatment procedure up to 6 months
The presence of pain will be a simple question in the case report form with two answer choices: yes or no.
Presence of Pain before local analgesic injection
Time frame: after TENS or gel administration before local analgesic injection at about 1 minute
The presence of pain will be a simple question in the case report form with two answer choices: yes or no.
Presence of Pain after treatment
Time frame: about 45 minutes at the end of the treatment visit
The presence of pain will be a simple question in the case report form with two answer choices: yes or no.
Level of pain before treatment based on Wong-Baker Faces (WBF) pain rating scale
Time frame: before the start of each treatment procedure up to 6 months
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.
Level of pain before local analgesic injection based on Wong-Baker Faces (WBF) pain rating scale
Time frame: after TENS or gel administration before local analgesic injection at about 1 minute
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.
Level of pain after treatment based on Wong-Baker Faces (WBF) pain rating scale
Time frame: about 45 minutes at the end of the treatment visit
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.
Level of dental anxiety before treatment using Visual Analog Scale
Time frame: before the start of each treatment procedure up to 6 months
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.
Level of dental anxiety before local analgesic injection using Visual Analog Scale
Time frame: after TENS or gel administration before local analgesic injection at about 1 minute
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.
Level of dental anxiety after treatment using Visual Analog Scale
Time frame: about 45 minutes at the end of the treatment visit
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.
4 secondary outcomes
Patient's comfort level preference
Time frame: up to 6 months
Treatment completion status
Time frame: up to 6 months
Reason for partially completed treatment
Time frame: up to 6 months
Supplemental anesthetic use
Time frame: up to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- BackgroundAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington DC, American Psychiatric Press. 1994.
- Background: PubMed 8142322Alvesalo 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.
- Background: PubMed 28879259Shim 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.
- Background: PubMed 28598183Cianetti 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.
- Background: PubMed 22117947Ogle 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.
- Background: PubMed 21323034Armfield JM, Milgrom P. A clinician guide to patients afraid of dental injections and numbness. SAAD Dig. 2011 Jan;27:33-9.
- Background: PubMed 28879311Lee 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.
- Background: PubMed 27040295Boyce 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.
- Background: PubMed 9161258Yap AU, Ho HC. Electronic and local anesthesia: a clinical comparison for operative procedures. Quintessence Int. 1996 Aug;27(8):549-53.
- Background: PubMed 2604057Abdulhameed 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.
- Background: PubMed 8378157teDuits 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.
- Background: PubMed 9566014Cho 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.
- Individual participant dataSharing planned: Yes. Overall findings and summary of results for primary and secondary outcome measures will be made available.
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Postoperative Pain After Endodontic Treatment, Dental Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayapriyaa Shanmugham, BDS DrPH principal investigator
Department of Pediatric Dentistry, Henry M. Goldman School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synapse TENS device and Topical anesthetic gel in people with Dental Fear and Anesthesia, Local, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Pain before treatment (time frame: before the start of each treatment procedure up to 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03779659, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.