Achieving a suitable method for the treatment of stable and recurrent pockets in the periodontal maintenance phase using less invasive methods and avoiding surgery
Diode laser (Biolase Inc, India) specifications are as follows: wavelength: 940 nm; power: 1 w; 300 micrometer symbol uninitiated fibers; continuous radiation mode and energy level: 80J / S. The laser fibers then are inserted into the pockets in such a way that they are in contact with the soft tissue wall of the pockets and parallel to the root surface and then move to the apical surface through a horizontal sweeping motion while remaining in contact with the soft tissue wall of the pockets. The control group undergo treatment using placebo laser and adjacent areas of the studied areas are treated with the treatment protocol used for the same area. The studied areas do not receive any local anesthesia and each patient is given oral health training at the same treatment session and will examine to re-measure the indices in the first and third months after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria included no systemic diseases, no smoking, no pregnancy and breastfeeding, no regular use of nonsteroidal anti-inflammatory drugs and antibiotics in the last three months, no history of any periodontal treatment for at least the last 3 months, and at least 3 teeth in two different quadrants with 4-7 mm PPD and positive BI. Exclusion criteria also included non-co-working patients, and patients with PI≥1.
Intervention groups
After collecting the indices, the areas in different quadrants with 4-7 mm PPD and positive BI are randomly divided into experimental (SRP + Laser) and control groups (SRP alone) by throwing coins.
Main outcome variables
Evaluation of PI PPD، CAL و BI indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201226049831N1
Registration date:2021-01-01, 1399/10/12
Registration timing:retrospective
Last update:2021-01-01, 1399/10/12
Update count:0
Registration date
2021-01-01, 1399/10/12
Registrant information
Name
Zahra Alizadeh Tabari
Name of organization / entity
Department of periodontics, International Campus, School of Dentistry, Tehran University of Medical
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 3503
Email address
drz.alizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-25, 1396/02/05
Expected recruitment end date
2018-04-30, 1397/02/10
Actual recruitment start date
2017-04-25, 1396/02/05
Actual recruitment end date
2018-04-30, 1397/02/10
Trial completion date
2018-06-05, 1397/03/15
Scientific title
Clinical efficacy of 940-nm diode laser in the treatment of persistent and recurrent pockets in the periodontal maintenance phase
Public title
Laser in periodontal maintenance phase
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
no systemic diseases, no smoking, no pregnancy and breastfeeding, no regular use of nonsteroidal anti-inflammatory drugs and antibiotics in the last three months, no history of any periodontal treatment for at least the last 3 months, and at least 3 teeth in two different quadrants with 4-7 mm PPD and positive BI.
Exclusion criteria:
included non-co-working patients, and patients with PI≥1.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
experimental (SRP + Laser) and control groups (SRP alone)
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple
After collecting the indices, the areas in different quadrants with 4-7 mm PPD and positive BI are randomly divided into experimental (SRP + Laser) and control groups (SRP alone) by throwing coins. The both groups are then matched for PI, based on the silness-loe plaque index and when treatment of the first area was determined, the next area was treated using another protocol.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the operator are not aware of the laser or placebo, and the third person makes the laser adjustments
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Before intervention and 1 and 3 months after intervention
Method of measurement
PPD is measured in millimeters from the free gingival margin to the base of the periodontal pockets using a manual periodontal probe. BI was defined as the presence or absence of bleeding 30 seconds after probing (±). CAL is also defined as the distance (mm) from cementoenamel junction (CEJ) to the bottom of the pockets.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: all oral areas are treated with SRP using ultrasonic pens. Laser is then performed on the experimental group to remove the inner layer of the pockets and thus reduce the microbial load using the diode laser according to the manufacturer's instructions.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School,Qazvin University of Medical Sciences
Full name of responsible person
Zahra Alizadeh Tabari
Street address
Bahonar
City
Qazvin
Province
Qazvin
Postal code
34157-59811
Phone
+98 28 3335 3061
Email
Drz.alizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Alizadeh Tabari
Street address
Bahonar
City
Qazvin
Province
Qazvin
Postal code
34157-59811
Phone
+98 28 3335 3061
Email
Drz.alizadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Alizadeh Tabari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar
City
Qazvin
Province
Qazvin
Postal code
34157-59811
Phone
0283336103
Email
Drz.alizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Alizadeh Tabari
Position
استادیار
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar
City
Qazvin
Province
Qazvin
Postal code
34157-59811
Phone
0283336103
Email
Drz.alizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Alizadeh Tabari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar
City
Qazvin
Province
Qazvin
Postal code
34157-59811
Phone
+98 28 3335 3061
Email
Drz.alizadeh@gmail.com
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
Not applicable
Title and more details about the data/document
The charts are in periodontics department of Qazvin dental school
When the data will become available and for how long
Starting 2 months after pulication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Access to view and review data
From where data/document is obtainable
By sending email to drz.alizadeh@gmail.com
What processes are involved for a request to access data/document