Comparing the effect of two methods of scaling and root planning (SRP) and diode laser therapy in treatment of pateints with moderate to severe periodontitis
Comparing the effect of two methods of scaling and root planning (SRP) and diode laser therapy in treatment of pateints with moderate to severe periodontitis.
Design
Randomization is done by random numbers table.
The sample size is 36 people.
The clinical trial has 3 groups. A control group and two intervention groups.
Double blind study with parallel groups.
Settings and conduct
The place is Birjand Dental School
Patients do not know the type of treatment they receive. Variables evaluators and data analyzers are unaware of which sample groups are located.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having at least 20 teeth in the mouth; having at least 1 area with a pocket depth of 4 mm and more in at least 2 quadrants of the mouth, with bleeding in the mild probing; having an index plaque less than 30%; availability during the research process and the signing of the written agreement.
Exclusion criteria: pregnancy; smoking; the presence of systemic disease that affects the periodontal condition; receiving scaling and root planning or antibiotic therapy in the last 6 months.
Intervention groups
Group 1: Laser diode therapy.
Group 2: Scaling and root planning.
Group 3: Scaling and root planing with laser diode therapy.
Main outcome variables
1- Clinical Attachment Level (CAL) : The distance between the CEJ and the gingival groove in millimeters.
2- bleeding on probing (BOP): presence or absence of bleeding 30 seconds after mild probing in the buccal and lingual area of the tooth.
3- probing pocket depth(PPD):the distance between the free gingiva to the end of gingival groove in millimeters.
4- Percentage of BOP Total Oral Area.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180712040442N1
Registration date:2018-09-08, 1397/06/17
Registration timing:registered_while_recruiting
Last update:2018-09-08, 1397/06/17
Update count:0
Registration date
2018-09-08, 1397/06/17
Registrant information
Name
Gholamreza Niknahad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 7729
Email address
gh.niknahad@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of two methods of scaling and root planning (SRP) and diode laser therapy in treatment of pateints with moderate to severe periodontitis
Public title
Comparing the effect of two methods of dental scaling in patients with gum disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 20 teeth in the mouth
Having at least 1 area with a pocket depth of 4 mm and more in at least 2 quadrants of the mouth, with bleeding in the mild probing
Having an index plaque less than 30%
Availability during the research process and the signing of the written agreement
Exclusion criteria:
Pregnancy
Smoking
The presence of systemic disease that affects the periodontal condition
Receiving scaling and root planning or antibiotic therapy in the last 6 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers tables were used for randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients participating are not aware of the type of treatment they receive. Also data analyzer and the variables evaluator dont know about groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2018-05-13, 1397/02/23
Ethics committee reference number
IR.BUMS.REC.1397.6
Health conditions studied
1
Description of health condition studied
Chronic peridontitis
ICD-10 code
1
ICD-10 code description
Certain infectious and parasitic diseases
Primary outcomes
1
Description
Clinical Attachment Level (CAL) : The distance between the CEJ and the gingival groove in millimeters
Timepoint
At the beginning of the study, 3, 6 and 12 weeks after the intervention
Method of measurement
By periodontal probes
2
Description
Bleeding on probing (BOP): presence or absence of bleeding 30 seconds after mild probing in the buccal and lingual area of the tooth
Timepoint
At the beginning of the study, 3, 6 and 12 weeks after the intervention
Method of measurement
Presence or absence of bleeding and seeing it by clinician
3
Description
Probing pocket depth(PPD):the distance between the free gingiva to the end of gingival groove in millimeters
Timepoint
At the beginning of the study, 3, 6 and 12 weeks after the intervention
Method of measurement
By periodontal probes
4
Description
Percentage of BOP Total Oral Area
Timepoint
At the beginning of the study, 3, 6 and 12 weeks after the intervention
Method of measurement
Presence or absence of bleeding and seeing it by clinician and Counting the percentage of bleeding areas
Secondary outcomes
empty
Intervention groups
1
Description
Control group: scaling and root planing
Category
Treatment - Other
2
Description
Intervention group: Using a laser diode system at a wavelength of 980 nm and a power of 3 watts, a pulse frequency of 15 Hz, an energy of 1.2 j/mm 2 in a pulsed state in each periodontal pocket using a 15 mm periotip for at least 30 seconds in periodontal pocket of each tooth
Category
Treatment - Other
3
Description
Intervention group: scaling and root planing followed by Using a laser diode system at a wavelength of 980 nm and a power of 3 watts, a pulse frequency of 15 Hz, an energy of 1.2 j/mm 2 in a pulsed state in each periodontal pocket using a 15 mm periotip for at least 30 seconds in periodontal pocket of each tooth
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic Dependent on Birjand Dental School
Full name of responsible person
Saeid Asadollahi
Street address
Emam Reza hospital - Taleghani avenue
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3223 3690
Email
ghanei_fateme@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ebrahim Miri Moghaddam
Street address
Birjand University of Medical Sciences, Ghaffari blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3223 4717
Email
public-r@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Gholamreza Niknahad
Position
dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Birjand University of Medical Sciences, Ghaffari Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 7729
Email
gh.niknahad@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyed Mohammad Ali Tabatabaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Birjand University of Medical Sciences, Ghaffari Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3223 4717
Email
sma.tabatabaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Gholamreza Niknahad
Position
dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Birjand University of Medical Sciences, Ghaffari Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 7729
Email
gh.niknahad@bums.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