The result of this study can be more effective in the treatment of patients with chronic periodontitis
The result of this study can be more economical in the treatment of patients with chronic periodontitis
The result of this study can be effective in treating patients with chronic periodontitis with fewer side effects
Design
A randomized clinical trial with a control group, parallel groups, one-way blind, on 19 patients. The patient is selected by admission to the office based on a three-choice selection envelope (one enrollment envelope and two random non-enrollment envelopes).
Settings and conduct
Patients with chronic periodontitis referred to the periodontist's office in Bushehr have been included in the study and the treatment protocol will be such that the whole mouth SRP will be performed with ultrasonic device and hand scaling devices along with local anesthesia in all patients in the first session. Complementary laser treatment will then be performed on days 1 and 7 after SRP treatment by another clinician. The laser treatment will be performed with a 940 nm diode laser and pilot light will be used for the control group to be one-sided blind. PI, BOP, PD, CAL indices will be measured before treatment and in 4 and 12 weeks after treatment. Then we will examine these 4 indices.
Participants/Inclusion and exclusion criteria
Patient with chronic periodontitis
Patient with full systemic health
Patient with at least two teeth in each Quadrant
Patient with a periodontal pocket depth of at least 3 millimeter
The ability of the patient or his companion to perform the necessary oral hygiene
Intervention groups
The group who the laser treatment will be performed
Main outcome variables
More effective treatment of patients with chronic periodontitis
More economical treatment of patients with chronic periodontitis
Treatment with fewer side effects in patients with chronic periodontitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200924048829N2
Registration date:2021-06-18, 1400/03/28
Registration timing:prospective
Last update:2021-06-18, 1400/03/28
Update count:0
Registration date
2021-06-18, 1400/03/28
Registrant information
Name
Saman Mohammadzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 3226
Email address
s.mohammadzadeh@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical effectiveness of diode laser (940 nm) as an adjunct to non-surgical therapy of chronic periodontitis
Public title
Effect of diode laser in chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic periodontitis
Patients with full systemic health
Patients with at least 2 teeth per each quadrant
Patients with at least 3 millimeter depth of tooth pocket
Patients or their attendants capable of maintaining oral hygiene
Exclusion criteria:
Patients who are not on time during the study
patients who develop systemic disease during the study
patients who lose tooth and there will be less than 2 Teeth per each quadrant
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
19
Randomization (investigator's opinion)
Randomized
Randomization description
For random specialization of quadrants and their selection as an intervention or control unit, dual block randomization method will be used. (For patients who have 4 complete quadrants to participate in the study and for patients who have only 2 quadrants are eligible to participate in the study Random number assignment method will be used).
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the fact that each patient selected in the study will be both an intervention group and a control group, they will enter the study split-mouth, ie the patient's mouth will be divided into equal quadrants and a quadrant as a control group under SRP treatment. It will be equipped with ultrasonic devices and hand-held scaling devices, and a quadrant as a laser group will be treated with a diode laser in addition to the SRP, and ultimately the outcome assessor will be completely unaware of the grouping.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Boushehr University of Medical Science
Street address
Moalem street
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۴۶۳۳۱۹۶
Approval date
2020-12-14, 1399/09/24
Ethics committee reference number
IR.BPUMS.REC.1399.184
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
Percentage of people with chronic periodontitis
Timepoint
In the study "Evaluation of clinical effectiveness of diode laser (940 nm) ..." periods of time in measuring of chronic periodontitis is at the beginning of study , 1 and 3 months after intervention
Method of measurement
In the study "Evaluation of clinical effectiveness of diode laser (940 nm) as an adjunct to non-surgical therapy of chronic periodontitis" how to measure the process variable can be "periodontal probe and mirror "
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Epic X 940 nm diode laser with 1.0-2 W settings. fiber diameter: 300/400 and mode of operation: cw parallel to the surface of the tooth cementum and on each tooth will be done for 20 seconds in this group
Category
Treatment - Devices
2
Description
Control group: Pilot light will be used
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Bushehr University of Medical Sciences
Full name of responsible person
Saman Mohammadzadeh
Street address
Moalem street
City
Bushehr
Province
Boushehr
Postal code
7514633196
Phone
+98 77 3332 3226
Email
s.mohammadzadeh@bpums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Moalem Ave
City
Bushehr
Province
Boushehr
Postal code
7514633196
Phone
+98 77 3332 3226
Email
R.Khamisipour@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Saman Mohammadzade
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bushehr University of Medical Science ,Moalem St.,Bushehr
City
Bushehr
Province
Boushehr
Postal code
7514633196
Phone
+98 77 3332 3226
Email
s.mohammadzadeh@bpums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Saman Mohammadzadeh
Position
َAssociate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bushehr University of Medical Science , Moalem St., Bushehr
City
Bushehr
Province
Boushehr
Postal code
7514633196
Phone
+98 77 3332 3226
Email
s.mohammadzadeh@bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Saman Mohammadzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bushehr University of Medical Science , Moalem St., Bushehr
City
Bushehr
Province
Boushehr
Postal code
7514633196
Phone
+98 77 3332 3226
Email
s.mohammadzadeh@bpums.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