Evaluation of the effect of adding low level laser irradiation to drug therapy in patients affected with burning mouth syndrome: A randomized clinical trial
Determining the effect of low level laser with drug therapy in patients with oral burning mouth syndrome in comparison with the control group
Design
A clinical randomized trial with a group control, with cross randomized groups, on 46 patients, used a random number table for randomization.
Settings and conduct
10 milligram Citalopram is prescribed for all patients who where diagnosed with burning mouth syndrome in the first week and increased to 20 milligram in the second week. The samples are then divided into two groups of intervention and control by using a random number table.In the intervention group, Thor DD2 low power diode laser with 810 nano meter wavelength, 0.5 watt power and continuous radiation is used. Laser irradiation is performed 3 times in a week for up to 4 sessions. the tip of the probe is square. Laser irradiation is applied in a contact method and in contact to point for 15 seconds for each area of the affected mucosa with an area of approximately 2 cm.all these procedures will be accomplished by specialist of oral medicine in laser center of Tehran university. In the control group, laser radiation will not be done.
Participants/Inclusion and exclusion criteria
Patients with a diagnosis of burning mouth syndrome who are systemically healthy and have a daily burning sensation for 4 to 6 months with constant or increased intensity during the day.
Intervention groups
Intervention group: Patients diagnosed with burning mouth syndrome are prescribed citaloperam increased from 10 milligram in the first week and to 20 milligram in the second week and then exposed to 920 nano meter diode laser for one month (12 sessions).
In the control group, patients with a diagnosis of burning mouth syndrome increased citalopram 10 milligram in the first week and to 20 milligram in the second week and were not exposed to laser radiation.
Main outcome variables
burning rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200905048623N1
Registration date:2020-09-21, 1399/06/31
Registration timing:registered_while_recruiting
Last update:2020-09-21, 1399/06/31
Update count:0
Registration date
2020-09-21, 1399/06/31
Registrant information
Name
Hooman Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 3288
Email address
h.ebrahimi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding low level laser irradiation to drug therapy in patients affected with burning mouth syndrome: A randomized clinical trial
Public title
Evaluation of the effect of adding low level laser irradiation to drug therapy in patients affected with burning mouth syndrome: A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are diagnosed with burning mouth syndrome.
Patients are systemically healthy.
Patients with normal oral mucosa should be examined clinically.
Patients have a burning sensation daily 4 to 6 months with constant or increased intensity during the day.
Exclusion criteria:
Patients with systemic problems manifested by burning mouth, such as diabetes, severe anemia, vitamin deficiency.
There are contraindications to laser administration such as pregnancy, epilepsy, cancer, chemotherapy.
Patients with severe psychiatric disorders, such as major depression
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized,individual unit Using a table of random numbers,no concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committiee of Islamic Azad university;Tehran dental branch
The amount of mouth burning is measured by asking the patient using a 0 to 10 graduated ruler.
Timepoint
The severity of burning will be measured before the start of treatment and at the end of each week after treatment (first week, second week, third week, fourth week) and the end of the third month.
Method of measurement
Patient questions are measured using the Visual Analogue Scale, a scale from 0 to 10
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The drug given to all patients is citalopram, the initial dose of which is 10 mg and after one week it is increased to 20 mg and used once a day for one month and in half of the patients, after one week from the start of drug treatment, laser treatment will be performed. In the intervention group, low power Thor DD2 (control unit,Thor,London,UK) diode laser with 810 nano meters wavelength and 0.5 watt power and continuous radiation is used about 15 seconds for each area were affected. The laser is performed about 3 times in a week for up to 4 sessions. The diameter of the probe tip is 1 centi meter(cm), the cross-sectional area is 0.785 cm2 and the energy density is 9.5 joules / cm2.
Category
Treatment - Devices
2
Description
Control group: The drug was given to all patients with citalopram (Sobhan Daru, Iran) whose initial dose was increased to 10 milligrams and after a week to 20 milligrams and used once a day for one month and half of Patients who do not receive laser treatment are in the control group.