Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05816200
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2023-04-03
Brief Title:
Comparison Between Two Treatments for Burning Mouth
Sponsor:
Universidade Federal do Rio Grande do Norte
Organization:
Universidade Federal do Rio Grande do Norte
Study Overview
Official Title:
Comparative Analysis of Low-Level Light Therapy and Transcutaneous Electrical Nerve Stimulation for Burning Mouth a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction The management of patients with chronic burning mouth is a challenge in clinical dentistry Objective To compare the effect of Low Level Laser Therapy LLLT and Transcutaneous Electrical Nerve Stimulation TENS in the treatment of burning mouth Materials and Methods Randomized clinical trial consisting of 25 patients with burning mouth who were treated by TENS n12 and by LLLT n13 Treatment was carried out weekly for 8 weeks Two-way ANOVA was used to verify whether there was a significant difference between times T0 baseline T1 after the 4th treatment session T2 after the 8th treatment session and T3 30 days after the end of treatment in in relation to symptoms analyzed using the Visual Analog Scale unstimulated salivary flow xerostomia and dysgeusia with TENS and LLLT interventions
Detailed Description:
Experimental group 20 participants with burning mouth were submitted to transcutaneous electrical nerve stimulation using a device at a frequency of 50 Hertz with intensity modulated according to the patients comfort ranging from 1 - 4 pulse amplitude with a duration of 25 minutes per session with one session per week totaling eight weeks of treatment at the end of the study The devices self-adhesive electrodes were fixed on the participants face following the path of the trigeminal nerve branch on the side affected by pain andor burning
Control group 20 participants with burning mouth underwent low power laser therapy with punctual applications of infrared laser L2 power of 100mW 808 nm 6 joules of energy60 seconds in the affected region keeping one centimeter of distance between the points until the entire area of the complaint was irradiated being held one session per week totaling eight weeks of treatment at the end of the study
Control group 20 participants with burning mouth underwent low power laser therapy with punctual applications of infrared laser L2 power of 100mW 808 nm 6 joules of energy60 seconds in the affected region keeping one centimeter of distance between the points until the entire area of the complaint was irradiated being held one session per week totaling eight weeks of treatment at the end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RBR-7fvcjkz | REGISTRY | BRAZILIAN REGISTRATION OF CLINICAL TRIALS ReBEC | None |