Trial Outcomes & Findings for Comparison Between Two Treatments for Burning Mouth (NCT NCT05816200)
NCT ID: NCT05816200
Last Updated: 2024-06-21
Results Overview
Changes in the intensity of pain/burning was determined by Visual Analogue Scale. Possible scores range from 0 (no pain) to 10 (worst possible pain).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Baseline (T0), after the 4th treatment session (4 weeks), after the 8th treatment session (8 weeks). ), 30 days after the end of treatment (8 weeks + 30 days).
Results posted on
2024-06-21
Participant Flow
The study population consisted of patients complaining of burning mouth treated at the Stomatology Service of the Department of Dentistry (DOD) at UFRN from April 2021 to February 2022.
Individuals who presented clinical changes in the oral mucosa such as erosive lichen planus, geographic tongue, infections, allergic reactions, trauma and injuries caused by physical or chemical agents were excluded.
Participant milestones
| Measure |
Grupo TENS
Participants with burning mouth underwent to transcutaneous electrical nerve stimulation.
Transcutaneous Electric Nerve Stimulation: Using a device at a frequency of 50 Hertz with intensity modulated according to the patient's 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 device's self-adhesive electrodes were fixed on the participant's face, following the path of the trigeminal nerve branch on the side affected by pain and/or burning.
|
Grupo LLLT
Participants with burning mouth underwent low-level laser therapy. One participant was excluded from this group for not completing the treatment protocol of the present study
Low-Level Light Therapy: Punctual applications of infrared laser (L2) (power of 100mW, 808 nm, 6 joules of energy/60 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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Grupo TENS
Participants with burning mouth underwent to transcutaneous electrical nerve stimulation.
Transcutaneous Electric Nerve Stimulation: Using a device at a frequency of 50 Hertz with intensity modulated according to the patient's 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 device's self-adhesive electrodes were fixed on the participant's face, following the path of the trigeminal nerve branch on the side affected by pain and/or burning.
|
Grupo LLLT
Participants with burning mouth underwent low-level laser therapy. One participant was excluded from this group for not completing the treatment protocol of the present study
Low-Level Light Therapy: Punctual applications of infrared laser (L2) (power of 100mW, 808 nm, 6 joules of energy/60 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Patients older than 18 years who had a burning or dysesthetic sensation in the oral mucosa that recurred daily for more than 2 h per day for more than 3 months, in the absence of clinically evident causal lesions, were included in the study. We also included patients with hyposalivation or any systemic alteration that could be related to a burning sensation in the oral mucosa.
Baseline characteristics by cohort
| Measure |
Grupo TENS
n=12 Participants
Participants with burning mouth underwent to transcutaneous electrical nerve stimulation
Transcutaneous Electric Nerve Stimulation: Using a device at a frequency of 50 Hertz with intensity modulated according to the patient's 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 device's self-adhesive electrodes were fixed on the participant's face, following the path of the trigeminal nerve branch on the side affected by pain and/or burning.
|
Grupo LLLT
n=13 Participants
Participants with burning mouth underwent low-level laser therapy
Low-Level Light Therapy: Punctual applications of infrared laser (L2) (power of 100mW, 808 nm, 6 joules of energy/60 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.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Continuous
|
58.36 years
STANDARD_DEVIATION 10.56 • n=99 Participants
|
61.36 years
STANDARD_DEVIATION 10.40 • n=107 Participants
|
59.86 years
STANDARD_DEVIATION 10.40 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Baseline (T0) · White
|
10 Participants
n=99 Participants
|
07 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Baseline (T0) · Brown
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
12 Participants
n=99 Participants • Patients older than 18 years who had a burning or dysesthetic sensation in the oral mucosa that recurred daily for more than 2 h per day for more than 3 months, in the absence of clinically evident causal lesions, were included in the study. We also included patients with hyposalivation or any systemic alteration that could be related to a burning sensation in the oral mucosa.
|
13 Participants
n=107 Participants • Patients older than 18 years who had a burning or dysesthetic sensation in the oral mucosa that recurred daily for more than 2 h per day for more than 3 months, in the absence of clinically evident causal lesions, were included in the study. We also included patients with hyposalivation or any systemic alteration that could be related to a burning sensation in the oral mucosa.
|
25 Participants
n=206 Participants • Patients older than 18 years who had a burning or dysesthetic sensation in the oral mucosa that recurred daily for more than 2 h per day for more than 3 months, in the absence of clinically evident causal lesions, were included in the study. We also included patients with hyposalivation or any systemic alteration that could be related to a burning sensation in the oral mucosa.
|
|
Painful symptoms
|
7.58 units on a scale
STANDARD_DEVIATION 2.64 • n=99 Participants
|
6.92 units on a scale
STANDARD_DEVIATION 2.54 • n=107 Participants
|
7.39 units on a scale
STANDARD_DEVIATION 2.48 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (T0), after the 4th treatment session (4 weeks), after the 8th treatment session (8 weeks). ), 30 days after the end of treatment (8 weeks + 30 days).Changes in the intensity of pain/burning was determined by Visual Analogue Scale. Possible scores range from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Grupo TENS
n=12 Participants
Participants with burning mouth underwent to transcutaneous electrical nerve stimulation.
Transcutaneous Electric Nerve Stimulation: Using a device at a frequency of 50 Hertz with intensity modulated according to the patient's 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 device's self-adhesive electrodes were fixed on the participant's face, following the path of the trigeminal nerve branch on the side affected by pain and/or burning.
|
Grupo LLLT
n=13 Participants
Participants with burning mouth underwent low-level laser therapy. One participant was excluded from this group for not completing the treatment protocol of the present study
Low-Level Light Therapy: Punctual applications of infrared laser (L2) (power of 100mW, 808 nm, 6 joules of energy/60 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.
|
|---|---|---|
|
Painful Symptoms
T0
|
7.58 score on a scale
Standard Deviation 2.64
|
6.92 score on a scale
Standard Deviation 2.54
|
|
Painful Symptoms
T1
|
5.08 score on a scale
Standard Deviation 2.94
|
5.33 score on a scale
Standard Deviation 3.23
|
|
Painful Symptoms
T2
|
3.17 score on a scale
Standard Deviation 2.48
|
4.50 score on a scale
Standard Deviation 2.88
|
|
Painful Symptoms
T3
|
5.75 score on a scale
Standard Deviation 2.49
|
3.75 score on a scale
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: Baseline (T0), after the 4th treatment session (4 weeks), after the 8th treatment session (8 weeks). ), 30 days after the end of treatment (8 weeks + 30 daysThe unstimulated salivary flow rate will be determined by the ratio volume of saliva collected, expressed in millimeters per minute (ml/min).
Outcome measures
| Measure |
Grupo TENS
n=12 Participants
Participants with burning mouth underwent to transcutaneous electrical nerve stimulation.
Transcutaneous Electric Nerve Stimulation: Using a device at a frequency of 50 Hertz with intensity modulated according to the patient's 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 device's self-adhesive electrodes were fixed on the participant's face, following the path of the trigeminal nerve branch on the side affected by pain and/or burning.
|
Grupo LLLT
n=13 Participants
Participants with burning mouth underwent low-level laser therapy. One participant was excluded from this group for not completing the treatment protocol of the present study
Low-Level Light Therapy: Punctual applications of infrared laser (L2) (power of 100mW, 808 nm, 6 joules of energy/60 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.
|
|---|---|---|
|
Salivary Flow
T0
|
0.32 average of ml collected per minute
Standard Deviation 0.23
|
0.27 average of ml collected per minute
Standard Deviation 0.20
|
|
Salivary Flow
T1
|
0.22 average of ml collected per minute
Standard Deviation 0.08
|
0.30 average of ml collected per minute
Standard Deviation 0.30
|
|
Salivary Flow
T2
|
0.36 average of ml collected per minute
Standard Deviation 0.22
|
0.22 average of ml collected per minute
Standard Deviation 0.13
|
|
Salivary Flow
T3
|
0.30 average of ml collected per minute
Standard Deviation 0.36
|
0.24 average of ml collected per minute
Standard Deviation 0.14
|
Adverse Events
Grupo LLLT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Grupo TENS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
PhD Cristianne Kalinne Santos Medeiros
Federal University of Rio Grande do Norte
Phone: +55(84)3342-2341
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place