- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- BU Henry M. Goldman School of Dental Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Synapse TENS device
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.
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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.
Other Names:
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ACTIVE_COMPARATOR: Topical anesthetic gel
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.
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of Pain before treatment
Time Frame: before the start of each treatment procedure up to 6 months
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The presence of pain will be a simple question in the case report form with two answer choices: yes or no.
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before the start of each treatment procedure up to 6 months
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Presence of Pain before local analgesic injection
Time Frame: after TENS or gel administration before local analgesic injection at about 1 minute
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The presence of pain will be a simple question in the case report form with two answer choices: yes or no.
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after TENS or gel administration before local analgesic injection at about 1 minute
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Presence of Pain after treatment
Time Frame: about 45 minutes at the end of the treatment visit
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The presence of pain will be a simple question in the case report form with two answer choices: yes or no.
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about 45 minutes at the end of the treatment visit
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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
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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.
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before the start of each treatment procedure up to 6 months
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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.
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after TENS or gel administration before local analgesic injection at about 1 minute
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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.
|
about 45 minutes at the end of the treatment visit
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Level of dental anxiety before treatment using Visual Analog Scale
Time Frame: before the start of each treatment procedure up to 6 months
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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.
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before the start of each treatment procedure up to 6 months
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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.
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after TENS or gel administration before local analgesic injection at about 1 minute
|
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.
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about 45 minutes at the end of the treatment visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient's comfort level preference
Time Frame: up to 6 months
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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)..
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up to 6 months
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Treatment completion status
Time Frame: up to 6 months
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Treatment completion status will be recorded as 'completed' or 'partially completed' on the Case Report Form at the conclusion of each treatment visit.
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up to 6 months
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Reason for partially completed treatment
Time Frame: up to 6 months
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For participants that do not complete both treatment procedures and are categorized as 'incomplete', the reason/s why will be documented.
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up to 6 months
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Supplemental anesthetic use
Time Frame: up to 6 months
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Amount of supplemental anesthesia if used for each of the two treatment procedures will be recorded in clinic notes after each treatment procedure.
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up to 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jayapriyaa Shanmugham, BDS DrPH, Department of Pediatric Dentistry, Henry M. Goldman School of Dental Medicine
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- Armfield JM, Milgrom P. A clinician guide to patients afraid of dental injections and numbness. SAAD Dig. 2011 Jan;27:33-9.
- 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.
- 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. Erratum In: Dent Clin North Am. 2017 Apr;61(2):xiii.
- Yap AU, Ho HC. Electronic and local anesthesia: a clinical comparison for operative procedures. Quintessence Int. 1996 Aug;27(8):549-53.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-37546
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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