To assess the effect of non-surgical periodontal treatment on blood parameters in patients with chronic periodontitis
Design
This a before-after clinical trial, phase II, in which 31 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with chronic periodontitis who will refer to School of Dentistry during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 25 to 55 years; Chronic periodontitis; Pocket depth of at least 5 mm
Attachment loss at least 3 mm
Bleeding during probing
Exclusion criteria:
A history of trauma or surgery in oral cavity; Using antibiotic during the past 3 months; Using ferrous supplements during the past 3 months; Transfusion during the past 3 months
Intervention groups
Intervention group: Non-surgical periodontal treatment using ultrasonography with input-power of 100 to 240 w and frequency of 50 to 60 Hz and output-power of 3 to 20 w and water pressure o f0.01 to 0.5 mega Pascal and dimension of 115×305×375
Control group: In comparison with before intervention
Main outcome variables
Measuring hematocrit before intervention and one month later through laboratory test
Measuring hemoglobin before intervention and one month later through laboratory test
Measuring red blood cells before intervention and one month later through laboratory test
Measuring CRP before intervention and one month later through laboratory test
Measuring LDL/VLDL before intervention and one month later through laboratory test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N212
Registration date:2018-03-12, 1396/12/21
Registration timing:registered_while_recruiting
Last update:2018-03-12, 1396/12/21
Update count:0
Registration date
2018-03-12, 1396/12/21
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The treatment effect of non-surgical periodontal treatment on blood parameters in patients with chronic periodontitis: a before-after clinical trial
Public title
The treatment effect of non-surgical periodontal treatment on blood parameters in patients with chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 25 to 55 years
Chronic periodontitis
Pocket depth of at least 5 mm
Attachment loss at least 3 mm
Bleeding during probing
Exclusion criteria:
A history of trauma or surgery in oral cavity
Using antibiotic during the past 3 months
Using ferrous supplements during the past 3 months
Transfusion during the past 3 months
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
IR.UMSHA.REC.1396. 571
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Measuring hematocrit
Timepoint
Before intervention and one month later
Method of measurement
Through laboratory test
2
Description
Measuring hemoglobin
Timepoint
Before intervention and one month later
Method of measurement
Through laboratory test
3
Description
Measuring red blood cells
Timepoint
Before intervention and one month later
Method of measurement
Through laboratory test
4
Description
Measuring CRP
Timepoint
Before intervention and one month later
Method of measurement
Through laboratory test
5
Description
Measuring LDL/VLDL
Timepoint
Before intervention and one month later
Method of measurement
Through laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Non-surgical periodontal treatment using ultrasonography with input-power of 100 to 240 w and frequency of 50 to 60 Hz and output-power of 3 to 20 w and water pressure o f0.01 to 0.5 mega Pascal and dimension of 115×305×375
Category
Treatment - Devices
2
Description
Control group: In comparison with before intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Omid Taherpoor
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
omid_tah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Omid Taherpoor
Position
Dental Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
omid_tah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Janet Moradi Haghgoo
Position
Periodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Janet_haghgoo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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