Clinical effectiveness of an 810-nm diode laser in addition to non-surgical periodontal therapy in patients with chronic periodontitis: A randomized single-blind clinical trial
Evaluation of the efficacy of an 810-nm diode laser as an adjunct to scaling and root planing (SRP) in improving periodontal parameters in patients with chronic periodontitis.
Design
randomized, superiority, parallel group, controlled trial with blinded outcome assessment
Settings and conduct
School of dentistry of Mashhad University of Medical Sciences
Participants/Inclusion and exclusion criteria
This clinical trial consists of 36 patients with chronic periodontitis and pocket depths of 4-6 mm
Intervention groups
One week after SRP, the quadrants are randomly divided into two sides; one side of each patient is selected as the laser group (SRP + laser) and the other side serves as the control group (SRP alone).
Main outcome variables
The clinical parameters including bleeding on probing (BOP), probing depth (PD), plaque index (PI), and clinical attachment level (CAL) are measured at baseline, and at 6 and 18 weeks after therapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091118002736N3
Registration date:2020-02-06, 1398/11/17
Registration timing:registered_while_recruiting
Last update:2020-02-06, 1398/11/17
Update count:0
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
Farzaneh Ahrari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 1883 1145
Email address
ahrarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical effectiveness of an 810-nm diode laser in addition to non-surgical periodontal therapy in patients with chronic periodontitis: A randomized single-blind clinical trial
Public title
effectiveness of diode laser in addition to periodontal therapy in patients with chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients older than 18 years with
chronic periodontitis with pocket depths of 4-6 mm in at least four teeth per jaw quadrant.
Exclusion criteria:
Patients who have received periodontal treatment over the 12 months preceding the study
those who have consumed antibiotics or anti-inflammatory drugs within the past month
patients with systemic disorders
pregnant, smokers or alcohol drinkers
patients having partial dentures
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
36
More than 1 sample in each individual
Number of samples in each individual:
2
The quadrants are divided into two sides (left and right); one side is randomly selected as the control group (SRP), and the other side as the laser group (SRP + laser).
Randomization (investigator's opinion)
Randomized
Randomization description
The test and control sides are determined randomly using a random numbers table.
Blinding (investigator's opinion)
Single blinded
Blinding description
The subject who assesses the outcomes is not aware of the test and control sides.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873477
Approval date
2015-09-25, 1394/07/03
Ethics committee reference number
IR.mums.sd.REC.1394.73
Health conditions studied
1
Description of health condition studied
chronic periodontitis and pocket depths of 4-6 mm
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Bleeding on probing (BOP):
Timepoint
before the treatment (baseline), at 6 and 18 weeks later
Method of measurement
The periodontal probe is inserted approximately 2 mm into the gingival sulcus at the buccal surface of each tooth.
2
Description
Probing depth (PD)
Timepoint
before the treatment (baseline), at 6 and 18 weeks later
Method of measurement
The periodontal probe is placed in the gingival sulcus and enters as far as possible into the pocket. The pocket depth is recorded in millimeters.
3
Description
Plaque index (PI)
Timepoint
before the treatment (baseline), at 6 and 18 weeks later
Method of measurement
To determine PI, plaque detection tablets are used. The plaque index is calculated by dividing the number of plaque containing surfaces by the total number of available surfaces (four surfaces ) and multiplying the result by 100.
Secondary outcomes
1
Description
Clinical attachment level (CAL):
Timepoint
before the treatment (baseline) as well as at 6 and 18 weeks later
Method of measurement
CAL is determined by measuring the distance in millimeters from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket using a periodontal probe.
Intervention groups
1
Description
One side of each patient is randomly selected as the laser group (SRP + laser).
Category
Treatment - Devices
2
Description
Control group: the other side of the patient is considered as the control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of dentistry of Mashhad University of Medical Sciences
Full name of responsible person
Majidreza Mokhtari
Street address
Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873476
Phone
+98 51 3882 9502
Email
Mokhtarim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873477
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Ahrari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873476
Phone
+98 51 3882 9502
Email
Ahrarif@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Ahrari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873476
Phone
+98 51 3882 9502
Email
Ahrarif@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Ahrari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873476
Phone
+98 51 3882 9502
Email
Ahrarif@mums.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