Comparision of a newly developed laser pen as a home care device versus conventional treatment in reduction of gingival inflammation reduction and acceleration of aphthous and herpetic lesion in up to 15 years old population
The aim of this study is to determiningofthe effect of laser tooth brush and also aphthous and herpetic laser pens in reduction of gingival inflammation after doing of conventional treatment and determining of the laser pen effect in reduction of pain and acceleration of wound healing in the patient with aphthous or herpetic lesion. inclusion criteria including gingivitis and chronic periodontitis in laser tooth brush group and minor aphthous laesion in the aphthous laser pen group and also the patient with herpetic lesion (in the three stages:premordial,vesicle,crust).exclusion criteria including:malignancy,thyroid ptoblem,pregnancy,phtosensitivity,epilepsy and mental retardations).this study will be done in the population up to 15 years old after disease diagnosis and fulfilment of patient's consent form and also education of the devices usage. the main outcoms including pain reduction, healing time, bleeding index, gingival index and gingival pocket index will be measured after starting of intervention and during three months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061113639N1
Registration date:2013-07-29, 1392/05/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-29, 1392/05/07
Registrant information
Name
Masoud Shabani
Name of organization / entity
Ardebi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1552 1412
Email address
m.shabani@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy For Research of Ardebil University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2014-03-19, 1392/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of a newly developed laser pen as a home care device versus conventional treatment in reduction of gingival inflammation reduction and acceleration of aphthous and herpetic lesion in up to 15 years old population
Public title
Construction of laser tooth brush ,laser aphthous pen and laser herpetic ulcer pen for improving of gum healthy and mouth wounds
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:up to 15 years old; fulfilment of consent form; suffer from gingivitis and periodontitis; herpetic ulcer and aphthous ulcer
exclusion criteria: pregnancy; malignancy; photosensitivity; thyroid problems; mental handicap; coagulopathy; corticosteroid application; epilepsy
Age
From 15 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethical committee of ardebil university of medical sciences
Street address
ardebil university of medical sciences
City
ardebil
Postal code
0451-5522196
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
arums.rec.1391.23
Health conditions studied
1
Description of health condition studied
periodontitis,aphthous ulcer,herpetic ulcer
ICD-10 code
k00-k14
ICD-10 code description
Diseases of oral cavity, salivary glands and jaws,Other viral diseases
Primary outcomes
1
Description
dental microbial plaque index
Timepoint
weekly and monthly
Method of measurement
disclosing agent and periodontal probe and observation
2
Description
periodontal pocket index
Timepoint
monthly
Method of measurement
periodontal probe
3
Description
gingival bleeding index
Timepoint
weekly and monthly
Method of measurement
periodontal pocket probe and observation
4
Description
gingival index
Timepoint
monthly
Method of measurement
periodontal probe and observation
5
Description
visual analogue scale(VAS)
Timepoint
befor intervention,immediately,daily,
Method of measurement
interview and standard cheklist
6
Description
function activity
Timepoint
daily
Method of measurement
interview and standard check list
7
Description
ulcer recurrent activity
Timepoint
monthly
Method of measurement
interview and standard check list
8
Description
time of cure
Timepoint
daily weekly monthly and annually
Method of measurement
interview and check list
Secondary outcomes
empty
Intervention groups
1
Description
intervention lased group:The group one (n = 10) is treated with
660 nm, 40 mW, continuous wave, 566 mw/cm2, class 2M, for five consecutive days (twice per
day, 30 seconds each session).
Category
Treatment - Devices
2
Description
intervention group one (lased grouo):a laser tooth brush with wavelength 660nm, output power 40mw,spot size 3mm, power density
566mw/cm2,irradiation time 10 seconds energy, density5.66 J/cm2, laser tooth brush was perpendicularly applied during laser emission at the labial (buccal) interdental papilla ,every other two days. This method is applied by patient at home, after receiving the face to face education and after getting the best skill training at the office in order to use it at home by wearing eye glasses protector.
Category
Treatment - Devices
3
Description
intervention lased group:The group one (n = 10) is treated with
655 nm, 40 mW, continuous wave, 655mw/cm2, class 2M, 30 seconds . this intervention is implemented for herpetic lesion in prodromal and vesicular stages but in the crust stage the laser setting will be the power of 40mw and 120 second irradiation time .
Category
Treatment - Devices
4
Description
in the first control group for aphthous ulcer we will use non laser red light as placebo ,two times per day for 30seconds for 5 days
Category
Treatment - Drugs
5
Description
inthe first control group for herpetic lesion we will use the nonlaser red light as placebo for30seconds in the primordial and vesicle stage and also for 120 seconds in the crust stage in one week
Category
Treatment - Drugs
6
Description
in the second control group for aphthous ulcer we will use the adcortyl in orabase ointment,4 times per day for 5 days
Category
Treatment - Drugs
7
Description
in thefirst control group for reduction of the gingival inflammation we will use the nonlaser red lihgt as placebo ,two times per day at the interdental papilla
Category
Treatment - Drugs
8
Description
in the second control group for reduction of the gingival inflammation reduction we will use the tooth brush plus tooth paste two times per day
Category
Treatment - Drugs
9
Description
in the second control group for herpetic lesion we will use the acyclovir ointment in the primordial and vesicle stage four times per day in oneweek
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental And Dermatological Clinics
Full name of responsible person
Masoud shabani And Hassan Adalatkhah
Street address
Sarcheshmeh Square
City
Ardebil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy For Research
Full name of responsible person
Dr.Haddi Piriee
Street address
Ardebil University of Medical Sciences
City
Ardebil
Grant name
10506000و10503000متمرکز و ردیف جاری
Grant code / Reference number
10506000،10503000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy For Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Masoud Shabani
Position
Head of Oral Health -School Health-Health Education Department DDS,Msc laserdontics
Other areas of specialty/work
Street address
Deputy for Health
City
Ardebil
Postal code
00984515521412
Phone
+98 45 1552 1412
Fax
+98 914 151 1477
Email
m.shabani@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Masoud Shabani
Position
Head of Oral Health-School Health-Health Education Department/DDS,Msc laserdontics
Other areas of specialty/work
Street address
Deputy For Health
City
Ardebil
Postal code
00984515521412
Phone
+98 45 1552 1412
Fax
+98 914 151 1477
Email
m.shabani@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Masoud Shabani
Position
Head of Oral Health-School Health-Health Education Department/DDS,Msc laserdontics
Other areas of specialty/work
Street address
Deputy for Health
City
Ardebil
Postal code
00984515521412
Phone
+98 45 1552 1412
Fax
+98 914 151 1477
Email
m.shabani@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)