The comparison of the effect of laser therapy versus mouthwash on the oral malodor in patients with chronic periodontitis: a single-blind randomized clinical trial
To compare the effect of laser therapy versus mouthwash on the oral malodor in patients with chronic periodontitis
Design
This is a single-blind randomized clinical trial, phase II, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible 60 patients with chronic periodontitis who will refer to the School of Dentistry during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 50 years
Chronic periodontitis with a minimum depth of 5 mm in at least 2 teeth
The plaque index less than or equal to 30%
Having at least 15 teeth
Exclusion criteria:
A history of antibiotic use in the last 6 months
A history of periodontal surgery
A history of digestive or respiratory diseases
Oral Fungal Infections
Oral lesions, tonsillitis, and adenoid enlargement
Intervention groups
Intervention group: Scrubbing plus Er, Cr: YSGG laser radiation with a wavelength of 2780 nm, MZ5 type, 10 degree angle to the inner surface of the packets, spirally, from bottom to top, for 10-15 min on the first, third and seventh days
Control group: Scrubbing plus Halita mouthwash 10 ml after brushing for one min, twice a day, for 7 days
Main outcome variables
Primary outcome: Assessing the oral malodor through physical examination with Rosenberg method in 2 and 12 weeks after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N224
Registration date:2018-06-16, 1397/03/26
Registration timing:registered_while_recruiting
Last update:2018-06-16, 1397/03/26
Update count:0
Registration date
2018-06-16, 1397/03/26
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of laser therapy versus mouthwash on the oral malodor in patients with chronic periodontitis: a single-blind randomized clinical trial
Public title
The comparison of the effect of laser therapy versus mouthwash on the oral malodor in patients with chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 50 years
Chronic periodontitis with a minimum depth of 5 mm in at least 2 teeth
The plaque index less than or equal to 30%
Having at least 15 teeth
Exclusion criteria:
A history of antibiotic use in the last 6 months
A history of periodontal surgery
A history of digestive or respiratory diseases
Oral Fungal Infections
Oral lesions, tonsillitis, and adenoid enlargement
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through drawing of lots
Blinding (investigator's opinion)
Single blinded
Blinding description
The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as single-blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-05-17, 1397/02/27
Ethics committee reference number
IR.UMSHA.REC.1397.94
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Assessing the oral malodor
Timepoint
2 and 12 weeks after treatment
Method of measurement
Through physical examination with Rosenberg method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Scrubbing plus Er, Cr: YSGG laser radiation with a wavelength of 2780 nm, MZ5 type, 10 degree angle to the inner surface of the packets, spirally, from bottom to top, for 10-15 min on the first, third and seventh days
Category
Treatment - Other
2
Description
Control group: Scrubbing plus Halita mouthwash 10 ml after brushing for one min, twice a day, for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Zahra Lotf Hagh Panah
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zlotfhaghpanah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Lotf Hagh Panah
Position
Dental Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zlotfhaghpanah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Banafsheh Poormoradi
Position
Periodontist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Poormoradi.banafsheh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available