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Comparison of the effect of two wavelengths of 660 and 808 nm as a low-level laser therapy on non-surgical periodontal treatment in patients with chronic periodontitis

Protocol summary

Study aim
Comparison of the effect of two wavelengths of 660 and 808 nm as a low-level laser therapy on non-surgical periodontal treatment in patients with chronic periodontitis
Design
Controlled, randomized, double-blind, parallel clinical trial, split mouth structure, sample size of 71 patients, Convenience sampling, selection of quadrants and wavelength type based on random shift pattern , in four-mode quadrant selection (AB-BA-CD-DC) which is repeated periodically based on the patient's number.In the first quadrant, the laser is 660 nm and in the second quadrant, the laser is 808 nm.
Settings and conduct
A double-blind study (patient and periodontal specialist) performed at the School of Dentistry examines the clinical parameters of periodontitis, including: clinica attachment level , bleeding on probing, gingival index and probing pocket depth in patients' premolars . SRP treatment is performed throughout the mouth. The diode laser is then irradiated with two wavelengths of 660 nm and 808 nm in two different quadrants and by the student.Diode laser treatment is repeated 1, 3 and 7 days later.
Participants/Inclusion and exclusion criteria
Inclusion: 1) chronic periodontitis with = 6-4PPD = and CAL ≥3mm in maxillary premolars 2) People over 20 years old No entry: 1) Any periodontal treatment in the last 6 months. 2) Use of antibiotics for the past 3 months for a week. 3) systemic disease affecting the periodontal tissue 4) Drug use. 5) Pregnancy and lactation. 6) Use of drugs that affect periodontal tissue 7) Patients with partial dentures. 8) fixed prostheses in premolars. 9) grade 3 mobility.
Intervention groups
Scaling and Root Planing is done in the whole mouth, then the diode laser with two wavelengths of 660 nm and 808 nm is irradiated in two
Main outcome variables
Improve periodontal parameters such as:clinica attachment level, bleeding on probing, gingival index and probing pocket depth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201005048942N1
Registration date: 2020-10-24, 1399/08/03
Registration timing: registered_while_recruiting

Last update: 2020-10-24, 1399/08/03
Update count: 0
Registration date
2020-10-24, 1399/08/03
Registrant information
Name
Faezeh Estaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 1331
Email address
estaji.f@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two wavelengths of 660 and 808 nm as a low-level laser therapy on non-surgical periodontal treatment in patients with chronic periodontitis
Public title
Investigation of the effect of two wavelengths of 660 and 808 nm on chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having chronic periodontitis with mmP-4-6 and CAL ≥3mm in maxillary premolars People over 20 years old
Exclusion criteria:
Any periodontal treatment has been performed in the last 6 months. Use of antibiotics for the past 3 months for a week. Existence of systemic diseases affecting periodontal tissue such as diabetes, cancer patients undergoing radiotherapy, malnutrition, zerostomia, hyperparathyroidism, hormonal diseases Smoking, alcohol or other drugs. Pregnancy and lactation. The use of drugs that affect the periodontal tissue, such as immunosuppressive drugs, anticonvulsants, antihypertensives. Patients with partial dentures. Patients with fixed prostheses in premolars. Teeth with grade 3 mobility.
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 71
More than 1 sample in each individual
Number of samples in each individual: 2
Two quadrants One jaw is selected from the four quadrants in the patient's mouth. In patients who have premolars in all four quadrants, the choice of quadrant and the wavelength used for it will be based on a random permutation pattern. In selecting the quadrant, we have four modes (AB-BA-CD-DC) which are repeated periodically based on the patient number. In the first quadrant, 660 nm laser light is irradiated and in the second quadrant, 808 nm laser light is irradiated.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected by Convenience sampling, but to select the studied quadrants and the type of wavelength, a random permutation pattern using a random number table will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient: Aware of laser radiation but does not know what wavelength each quadrant has received. Periodontal specialist: Measures clinical parameters but does not know what wavelength each quadrant has received.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Shahriar 5, Shahriar Town,Gorgan
City
Gorgan
Province
Golestan
Postal code
۴۹۱۳۹۸۳۶۳۵
Approval date
2020-09-30, 1399/07/09
Ethics committee reference number
IR.GOUMS.REC.1399.196

Health conditions studied

1

Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.30
ICD-10 code description
Chronic periodontitis, unspecified

Primary outcomes

1

Description
Clinica attachment level ,Bleeding on probing, Gingival index, . Probing pocket depth
Timepoint
1,3 and 6 month after treatment
Method of measurement
williams periodontal probe(Hu-Friedy,Chicago/USA)

Secondary outcomes

1

Description
Improving periodontal status and oral hygiene
Timepoint
1, 3 and 6 months after treatment
Method of measurement
williams periodontal probe(Hu-Friedy,Chicago/USA)

Intervention groups

1

Description
Intervention group 1:After Scaling and Root Planing Low level laser (Klas-DX, Konftec, Malaysia) with a wavelength of 660 nm. Diode laser treatment is repeated 1, 3 and 7 days after the initial treatment. How to irradiate laser light from buccal and lingual surfaces (palatal) non-contact (distance of fiber with tissue 0.5 mm) and continuous (power) with power W2 / 0 for s20 with fiber diameter ^ 2 cm 1 is for the buccal and lingual surfaces of the tooth.
Category
Treatment - Other

2

Description
Intervention group 2:After Scaling and Root Planing Low level laser (Klas-DX, Konftec, Malaysia) is irradiated with a wavelength of 808 nm. Diode laser treatment is repeated at intervals of 1, 3 and 7 days after initial treatment. How to irradiate laser light from buccal and lingual surfaces (palatal) non-contact (distance of fiber with tissue 0.5 mm) and continuous (power) with power W2 / 0 for s20 with fiber diameter ^ 2 cm 1 is for the buccal and lingual surfaces of the tooth.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Gorgan Dental School
Full name of responsible person
Amir Reza Ahmadinia
Street address
Shahriar 5, Shahriar Town, Gorgan Dental School
City
Gorgan
Province
Golestan
Postal code
۴۹۱۳۹۸۳۶۳۵
Phone
+98 17 3262 7824
Email
Ar.ahmadinia@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Roshandel
Street address
the first of Shast Kola road, 5 km of Gorgan-Sari road, Higher education complex of Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
۷۴۵۱۵۴۹۳۴۱
Phone
+98 17 3245 1660
Email
roshandel@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Amir Reza Ahmadinia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahriar 5 St., Shahriar Town, Gorgan
City
Gorgan
Province
Golestan
Postal code
۴۹۱۳۹۸۳۶۳۵
Phone
+98 17 3193 2173
Email
Ar.ahmadinia@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Faezeh Estaji
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Ahmadi 11Ave., Abuzar 21 St.,Gorgan
City
Gorgan
Province
Golestan
Postal code
4918653885
Phone
+98 17 3244 0386
Email
estaji.f@goums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Faezeh Estaji
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Ahmadi 11Ave., Abuzar 21 St.,Gorgan
City
Gorgan
Province
Golestan
Postal code
4918653885
Phone
+98 17 3244 0386
Email
estaji.f@goums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Since 1399
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no conditions.
From where data/document is obtainable
estaji.f@goums.ac.ir
What processes are involved for a request to access data/document
There is no process
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