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Comparison of salivary markers (lactate dehydrogenase and hemoglobinA1C) in patients with severe chronic periodontitis before and after phase one periodontal treatment

Protocol summary

Study aim
Determination of LDH and HbA1c levels in patients with severe chronic periodontitis before and after phase one of periodontal treatment
Design
Clinical efficacy without control group and without the need for randomization and Blinding on 30 patients before and after receiving phase 1 periodontal treatment
Settings and conduct
30 person of Clients to the School of Dentistry with entry criteria have selected and after explaining the plan, patients are asked to avoid eating and drinking 2 hours before sampling, then they are asked to spit their saliva in sterile containers (Falcon 15 cc tubes)By spitting method for 2 minutes. and will be tried 3 ml of non-stationary saliva will be collected from each person and this will be done again 1 month after phase 1 of periodontal treatment
Participants/Inclusion and exclusion criteria
inclusion:1- People between 30 and 50 years old 2 - No smoking and other tobacco products 3- Failure to take effective drugs 4- Non-pregnant and non-breastfeeding women 5- consent of the patient 6- Not taking antibiotics in the last 6 months 7- Lack of previous periodontal treatments 8. There are at least 20 teeth in the mouth 9- Do not consume corticosteroids 10. Severe chronic periodontitis 11. Lack of systemic disease affecting periodontal conditions 12. The presence of a larger CAL equals at least two teeth.Exclusoion:Patients who do not want to continue working for any reason during the research process or who miss the entry criteria during the research process will be excluded from the study.
Intervention groups
Phase 1 Periodontal treatment for patients with severe chronic periodontitis
Main outcome variables
Lactate dehydrogenase and hemoglobin A1c

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180122038475N3
Registration date: 2020-06-15, 1399/03/26
Registration timing: registered_while_recruiting

Last update: 2020-06-15, 1399/03/26
Update count: 0
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
somaye ansarimoghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 1814
Email address
ansarimoghadam@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-14, 1399/03/25
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of salivary markers (lactate dehydrogenase and hemoglobinA1C) in patients with severe chronic periodontitis before and after phase one periodontal treatment
Public title
Comparison of lactate dehydrogenase and hemoglobinA1C in patients with severechronic periodontitis before and after SRP
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
People between 30 and 50 years old Non-pregnant and non-breastfeeding women Conscious consent of the patient There are at least 20 teeth in the mouth Severe chronic periodontitis The presence of a larger CAL is equal to 5 at least two teeth
Exclusion criteria:
Smoking and other tobacco products Taking effective over-the-counter medications Antibiotics have been used for the past 6 months previous periodontal treatment use corticosteroids Existence of systemic disease affecting periodontal conditions
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
ZaUMS Main campus, Jenat Boulevard., Zahedan, Sistan and Baluchestan, Iran
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.ZAUMS.REC.1398.422

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
Lactate dehydrogenase
Timepoint
Periodontal treatment before phase 1 and periodontal treatment 1 month after phase 1
Method of measurement
Laboratory tests of lactate dehydrogenase

2

Description
Hemoglobin A1c
Timepoint
Periodontal treatment before phase 1 and periodontal treatment 1 month after phase 1
Method of measurement
Hemoglobin A1c Laboratory Kit

Secondary outcomes

empty

Intervention groups

1

Description
Phase 1 Periodontal treatment:scaling and rootplaning
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences
Full name of responsible person
Somaye Ansari Moghadam
Street address
College of dentistry , Eastern Azadegan St. , Zahedan City
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Email
ansarimoghadam@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nour Mohammad Bakhshani
Street address
Ethics Committee of Zahedan University of Medical Sciences
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5715
Email
ansarimoghadam@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Somaye Ansari Moghadam
Position
Assistant Professor of Periodontics Department, Dental College of Zahedan Universit
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental College of Zahedan Universityof Medical Sciences, Azadegan St.Zahedan, Iran
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
ansarimoghadam@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Somaye Ansari Moghadam
Position
Assistant Professor of Periodontics Department, Dental College of Zahedan University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental College of Zahedan University of Medical Sciences, Azadegan St. Zahedan, Iran
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
Ansarimoghadam@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
hadis abilnajafzadeh
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
College of dentistry , Eastern Azadegan St. Zahedan city
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3223 8659
Email
hadisnajafzadeh2@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
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