Effect of conventional scaling and root planning with and without diode laser 940 nm on gingival sulcus disinfection in chronic periodontitis patients: a randomized clinical trial
To assess the effect of conventional scaling and root planning with and without diode laser 940 nm on gingival sulcus disinfection in chronic periodontitis patients
Design
This is a randomized clinical trial, in which 40 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible chronic periodontitis patients who will refer to School of Dentistry during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years;
At least 15 teeth;
Visible plaque (less than or equal to 30%);
At least 2 teeth with a pocket depth of more than 4 mm
Exclusion criteria:
Pregnancy or breastfeeding;
Using alcohol or cigarette;
Using vitamin;
Using antibiotic;
Using anti-inflammatory drugs;
Periodontal treatment in the past year
Intervention groups
Intervention group: Conventional scaling and root planning plus radiating diode laser 940 nm, Type E3 and an optical fiber diameter of 300 microns at 10 degrees angle for 15 seconds
Control group: Conventional scaling and root planning
Main outcome variables
Primary outcome:
Probing pocket depth,
Measuring clinical attachment level,
Measuring gingival index,
Measuring bleeding on probing,
Measuring plaque index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N234
Registration date:2018-09-04, 1397/06/13
Registration timing:retrospective
Last update:2018-09-04, 1397/06/13
Update count:0
Registration date
2018-09-04, 1397/06/13
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
2018-04-30, 1397/02/10
Expected recruitment end date
2018-07-01, 1397/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of conventional scaling and root planning with and without diode laser 940 nm on gingival sulcus disinfection in chronic periodontitis patients: a randomized clinical trial
Public title
Effect of conventional scaling and root planning with and without diode laser 940 nm on gingival sulcus disinfection in chronic periodontitis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years;
At least 15 teeth;
Visible plaque (less than or equal to 30%);
At least 2 teeth with a pocket depth of more than 4 mm
Exclusion criteria:
Pregnancy or breastfeeding;
Using alcohol or cigarette;
Using vitamin;
Using antibiotic;
Using anti-inflammatory drugs;
Periodontal treatment in the past year
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the right and left sides of the patients to the intervention and control groups through drawing of lots
Blinding (investigator's opinion)
Not blinded
Blinding description
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
2018-04-28, 1397/02/08
Ethics committee reference number
IR.UMSHA.REC.1397.044
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
Probing pocket depth
Timepoint
Before intervention, 4, and 8 weeks after intervention
Method of measurement
By physical examination
2
Description
Measuring clinical attachment level
Timepoint
Before intervention, 4, and 8 weeks after intervention
Method of measurement
By physical examination
3
Description
Measuring gingival index
Timepoint
Before intervention, 4, and 8 weeks after intervention
Method of measurement
By physical examination
4
Description
Measuring bleeding on probing
Timepoint
Before intervention, 4, and 8 weeks after intervention
Method of measurement
By physical examination
5
Description
Measuring plaque index
Timepoint
Before intervention, 4, and 8 weeks after intervention
Method of measurement
By physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Conventional scaling and root planning plus radiating diode laser 940 nm, Type E3 and an optical fiber diameter of 300 microns at 10 degrees angle for 15 seconds
Category
Treatment - Other
2
Description
Control group: Conventional scaling and root planning
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Leila Mohammadpoor
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
leilamohamadpour93@gmail.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
Leila Mohammadpoor
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
leilamohamadpour93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Nazli Rabianejad
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
nazlirabi@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
+98 918 111 3963
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