Non-Pharmacological Pain Management, Orthodontic Discomfort
Conditions
Keywords
TENS, Orthodontic Treatment, Non-pharmacological pain management, Orthodontic Discomfort
Brief summary
The goal of this clinical trial is to learn if Transcutaneous Electric Nerve Stimulation (TENS) device works to reduce discomfort during orthodontic treatment, by using orthodontic separators to mimic the discomfort of braces. The main questions it aims to answer are: * Does TENS device lower the participants level of discomfort? * Will TENS device be effective with orthodontic tooth movement? Researchers will place the separators on different sides of upper and lower first molars. TENS device will be applied on each participant on one of both teeth (according to their group), so that the results can be compared within the same person. Participants will: * Visit the clinic after 12 or 24 hours (depends on their group) * Stay on dental chair while TENS device is applied. * Rate the discomfort level on VAS scale before and after TENS device application.
Interventions
OTHERTENS Device
No intervention is needed in the study. The device is being used in all groups but in different ways.
Sponsors
Ajman University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants don't know which group they are assigned to.
Intervention model description
This study used a simple random sampling method. Each participant will have orthodontic separators applied medial and distal to contralateral first molars. Then each participant will have TENS device applied to one of the contralateral first molars (according to their group), making the other first molar of each participant to act as their own control.
Eligibility
Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Full permanent dentition excluding third molars. * Sound not carious nor endodontic treated contralateral first molars. * Interproximal contact mesial and distal to first molar present on both upper and lower molars.
Exclusion criteria
* Dental pain. * Heart arrhythmias. * History of seizures. * Taking any pain medication during the test period. * Missing tooth excluding third molars. * Endodontic treated or carious first molar. * Spacing mesial or distal to the first molar.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | From orthodontic separators application to 12 or 24 hours depends on the participant group. | To rate the level of discomfort pre and post TENS device application, where 0 is equivalent to no discomfort and 10 indicates most discomfort possible (the more reduction of the level of discomfort the better for the study results). |
Countries
United Arab Emirates
Contacts
PRINCIPAL_INVESTIGATORJeny M George, MDS
Ajman University
Outcome results
None listed