This study was undertaken to evaluate the effect of 940-nm diode laser on clinical parameters and microbial load in patients with chronic periodontitis.
Design
Randomized, single blinded, clinical trial
Settings and conduct
This study will be carried out on patients refereed to Faculty of Dentistry, Shahed University, Tehran. Full-mouth SRP will be done with an ultrasonic device. Oral hygiene instructions, consisting of correct brushing technique and correct use of dental floss will be given to each patients. One week after completion of SRP in the test group after simple randomization with random number , 940-nm diode laser beams will be applied. One tooth from each quadrant will be selected for evaluation of clinical and microbiological parameters. Sterile paper cones will be placed in the deepest area of the pocket and after 20 seconds will be immediately placed in tubes for transferring to the laboratory. All the four samples of each patient will be sent to the laboratory. Real-time PCR will be used to determine pathogen counts.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
-Subjects had moderate-to-severe chronic periodontitis.
-At least one pocket, measuring 4‒6 nm in depth, and bleeding on probing in each quadrant.
-Systemic health.
-Lack of active root infection or teeth caries.
Exclusion criteria:
-Lack of compliance.
-Periodontal pockets deeper than 10 mm, and severe luxation (third degree).
-Antibiotics intake during the research and in previous three months.
-Smoking
Papillary bleeding index (PBI), probing pocket depth (PPD), clinical attachment level (CAL), modified gingival index (MGI) and margin level (ML), and microbial load
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161216031432N2
Registration date:2018-04-02, 1397/01/13
Registration timing:retrospective
Last update:2018-04-02, 1397/01/13
Update count:0
Registration date
2018-04-02, 1397/01/13
Registrant information
Name
zahra zohri
Name of organization / entity
Shahed University,Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 9210
Email address
z.zohri@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
no fund
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2018-02-04, 1396/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the clinical and microbiologic effects of 940 nm Diode laser as an adjunct to scaling and root planing in treatment of Chronic periodontitis
Public title
Laser in periodontitis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe chronic generalized periodontitis, presence of one pocket
measuring 4‒6 mm in depth and bleeding on probing in all the 4 quadrants
Systemic health
Exclusion criteria:
Presence of radicular infection or active caries
Systemic diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization of subjects with random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blind; participants
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University of Medical Sciences
Street address
Shahed University,Tehran, Iran. N71, Italia Str, Vesal Ave, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.Shahed.REC.1395.220
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic pericoronitis Periodontitis: NOS complex simplex
Primary outcomes
1
Description
Pocket Probing Depth
Timepoint
before treatment,1 month and 3 month after treatment
Method of measurement
The distance between the gingival margin and the pocket base, which will be measured at 6 points of each tooth (mesiobuccal, buccal, distobuccal, distolingual, lingual and mesiolingual) with the use of a Williams graduated probe. The mean probing depth at each site will be registered as the probing depth in that area.
2
Description
Clinical Attachment Level
Timepoint
before treatment,1 month and 3 month after treatment
Method of measurement
Williams probe
3
Description
Gingival Level
Timepoint
before treatment,1 month and 3 month after treatment
Method of measurement
Williams probe
4
Description
Modified Gingival Index
Timepoint
before treatment,1 month and 3 month after treatment
Method of measurement
Observation
5
Description
Papillary Bleeding Index
Timepoint
before treatment,1 month and 3 month after treatment
Method of measurement
Periodontal probe and observation
6
Description
Porphyromonas gingivalis
Timepoint
before treatment,1 month and 3 month after treatment
Method of measurement
Real time polymerase chain reaction
7
Description
Tannerella forsythia
Timepoint
before treatment,1 month and 3 month after treatment
Method of measurement
Real time polymerase chain reaction
8
Description
Treponema denticola
Timepoint
before treatment,1 month and 3 month after treatment
Method of measurement
Real time polymerase chain reaction
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
The control group: The treatment consists of scaling with an ultrasonic device and oral hygiene instructions, including how to brush correctly and use dental floss.
Category
Treatment - Devices
2
Description
The intervention group: Scaling will be carried out with the use of an ultrasonic device in association with oral hygiene instructions, including correct brushing and use of dental floss. One week after scaling and root planing, 940-nm diode laser beams w
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry of Shahed University
Full name of responsible person
Zahra Zohri (post graduate)
Street address
Shahed University, Persian gulf highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 4445 9468
Email
z.zohri@shahed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
No sponser
Full name of responsible person
Zahra Zohri
Street address
Shahed University, Persian gulf highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 4445 9468
Email
z.zohri@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
No sponser
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
School of Dentistry of Shahed University
Full name of responsible person
Zahra Zohri
Position
Post graduate
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Shahed University, Persian gulf highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 8895 9210
Fax
Email
z.zohri@shahed.ac.ir
Web page address
http://shahed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry of Shahed University
Full name of responsible person
Zahra Zohri
Position
Postgraduate
Latest degree
Medical doctor
Other areas of specialty/work
Street address
N71, Italia Str, Vesal Ave
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 8895 9210
Fax
Email
z.zohri@shahed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry of Shahed University
Full name of responsible person
Zahra Zohri
Position
Postgraduate
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
N71, Italia Str, Vesal Ave
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 8895 9210
Fax
Email
z.zohri@shahed.ac.ir
Web page address
http://shahed.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data after removal of private information will release via article publication.
When the data will become available and for how long
6 months after publication.
To whom data/document is available
Students and professors
Under which criteria data/document could be used
By written consent of investigators.
From where data/document is obtainable
Dr. Zohri
What processes are involved for a request to access data/document