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The effect of chronic periodontitis treatment on blood parameters

Protocol summary

Study aim
The effect of treatment of  moderate to severe chronic periodontitis on blood parameters
Design
This clinical trial was performed on 36 patients with chronic periodontitis (moderate to severe) and 18 patients with periodontal disease referred to Baghei Hematology Clinic of Shahid Sadoughi Hospital, Khatam-ol-Anbia Clinic and Dental School of Yazd
Settings and conduct
The patients under study in this study included 36 male patients referring to Baghei Hematology Clinic of Shahid Sadoughi Hospital and Khatam-ol-Angiyah Clinic of Yazd (who have been requested for this study independently of this study) with moderate to severe chronic periodontitis The average age of 25-50 years of age, which is systemically healthy, will be selected as a group, of which 18 will begin immediately periodontal treatment and will be performed for free after 18 weeks of treatment for the remaining 18, and For the control group, 18 patients with similar age and sex conditions were filled Vdntaly were healthy, elected
Participants/Inclusion and exclusion criteria
Inclusion criteria: male patients (25-50 years)، lack of systemic diseases, lack of the history hospitalization, no history of receiving or donating blood, no periodontal treatment in the last three months. Exclusion criteria: a patients who doesn't attend for giving blood sample after 6 weeks or when periodontal treatment was not conducted completely for any specific reason
Intervention groups
36 patients with chronic periodontitis (moderate to severe) and 18 patients with periodontal disease referred to Baghei Hematology Clinic of Shahid Sadoughi Hospital ،Khatam-ol-Anbia Clinic and Dental School Yazd
Main outcome variables
Bleeding on probing ( BOP ), periodontal pocket depth ( PPD ), clinical attachment loss (CAL), Hemoglobin, Hematocrit, Mean Corpuscular volume ( MCV ), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC ), Ferritin, Vitamin D,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151013024509N3
Registration date: 2018-02-09, 1396/11/20
Registration timing: prospective

Last update: 2018-02-09, 1396/11/20
Update count: 0
Registration date
2018-02-09, 1396/11/20
Registrant information
Name
Fahimeh Rashidi Maybodi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 519 6227
Email address
f-rashidi63@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-14, 1396/11/25
Expected recruitment end date
2018-04-14, 1397/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chronic periodontitis treatment on blood parameters
Public title
The effect of periodontal treatment on blood parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male patients ( 25-50 years ) With lack of systemic diseases such as: diabetes, kidney disease, cancer Fungal and respiratory diseases No history of hospitalization No history of receiving or donating blood No periodontal treatment in the last three months Non- use of cigarettes, alcohol and tobacco Serum ferritin levels greater than 50 ng/ml Do not use the following medications: warfarin, anti-coagulants, lithium, aspirin Corticosteroid drugs Heparin, phenytoin Anti-hypertensive drugs Non steroid anti-inflamatory drugs Antibiotics Antiarrhythmic drugs Drugs used in the treatment of kidney patients
Exclusion criteria:
A patient who doesn't attend for giving blood sample after 6 weeks when periodontal treatment was not conduced completely for any specefic reason
Age
From 25 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 54
More than 1 sample in each individual
Number of samples in each individual: 1
All patients undergo periodontal examination, including the recording of PPD, BOP, and CAL indexs, and blood samples are taken from the patient at the same time. and will be sent to the laboratory for the evaluate blood parameters including hemoglobin (Hb), ferritin, hematocrit, MCV, MCH, MCHC and Vit D.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by random number table
Blinding (investigator's opinion)
Single 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 shahid sadoughi University of Medical Sciences
Street address
shahid sadoughi University of Medical Sciences ،Shahid Bahonar Square
City
Yazd
Province
Yazd
Postal code
12345
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.SSU.REC.13950242

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
Moderate to severe chronic periodontitis
Timepoint
At the beginning of the study (before the intervention) and 6 weeks after the beginning of the study
Method of measurement
All patients under periodontal examination, including the recording of bleeding on probing (BOP), periodontal pocket depth ( PPD) and clinical attachment loss (CAL) indices

Secondary outcomes

1

Description
Blood parameters
Timepoint
At the beginning of the study (before the intervention) and after 6 weeks
Method of measurement
Taking blood samples of patients

Intervention groups

1

Description
Control group: 18 people with healthy periodontium, at the beginning of the study, complete periodontal examinations and taking blood samples and sent to the laboratory, 6 weeks later, a re-examination and taking blood samples
Category
Behavior

2

Description
Intervention group: 18 patient with moderate to severe chronic periodontitis, at baseline, full periodontal examinations,scaling and root planing, taking blood samples and sending to the laboratory, 6 weeks later, re-examination and taking of blood samples.
Category
Treatment - Other

3

Description
Intervention group: 18 patients with moderate to severe chronic periodontitis, at baseline, full periodontal examinations, taking blood samples, and sent to the laboratory, 6 weeks later, re-examination, scaling and root planing, taking of blood samples
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Faculty of Dentistry Yazds
Full name of responsible person
Ali Reza Ebrahimi
Street address
Imam Reza Square, Shahid Sadoughi Faculty of Dentistry Yazd
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3625 1222
Fax
+98 35 3625 0334
Email
Ebrahimi.Dentist@Gmail.Com

2

Recruitment center
Name of recruitment center
Khatam al-Anbia Clinic Yazd
Full name of responsible person
Alireza Ebrahimi
Street address
Taleghani Blvd
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3676 6860
Email
Ebrahimi.Dentist@Gmail.Com

3

Recruitment center
Name of recruitment center
Baghaee Pour Clinic
Full name of responsible person
Alireza Ebrahimi
Street address
Ibn Sina Street, Safayee, Yazd
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3183 3737
Email
Ebrahimi.dentist@Gmail.Com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alireza Danesh Kazemi
Street address
Shahid Sadoughi Faculty of Dentistry, Imam Reza Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
F-rashidi63@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fahimeh Rashidi Maybodi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dahe Fajr Blvd, Dental School
City
Yazd
Province
Yazd
Postal code
89195/165
Phone
+98 35 3625 1222
Fax
+98 35 3625 0334
Email
F-rashidi63@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ali Reza Ebrahimi
Position
4. Post – Graduate Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dahe Fajr, Blvd, Dental School
City
Yazd
Province
Yazd
Postal code
89195/165
Phone
+98 35 3625 1222
Fax
+98 35 3625 0334
Email
Ebrahimi.Dentist@Gmail.Com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ali Reza Ebrahimi
Position
Post – Graduate Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dahe Fajr Blvd, Dental School
City
Yazd
Province
Yazd
Postal code
89195/165
Phone
+98 35 3625 1222
Fax
+98 35 3625 0334
Email
Ebrahimi.Dentist@Gmail.Com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
The whole data is shared
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Email, Call
From where data/document is obtainable
Alireza Ebrahimi, 09360210362, 09177315007, Ebrahimi.Dentist@Gmail.Com
What processes are involved for a request to access data/document
After sending the email, the data will be transmitted
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