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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 Hours Maxilla | Experimental | Participants recalled after 12 hours of separators application and TENS device applied on maxillary arch (mandibular arch is considered as control). |
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| 12 Hours Mandible | Experimental | Participants recalled after 12 hours of separators application and TENS device applied on mandibular arch (maxillary arch is considered as control). |
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| 24 Hours Maxilla | Experimental | Participants recalled after 24 hours of separators application and TENS device applied on maxillary arch (mandibular arch is considered as control). |
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| 24 Hours Mandible | Experimental | Participants recalled after 24 hours of separators application and TENS device applied on mandibular arch (maxillary arch is considered as control). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS Device | Other | No intervention is needed in the study. The device is being used in all groups but in different ways. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | 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. | From orthodontic separators application to 12 or 24 hours depends on the participant group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajman University | Ajman | Ajman Emirate | 00000 | United Arab Emirates |
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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.
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Participants don't know which group they are assigned to.