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Evaluation Of The Effect Of Chronic Periodontitis Treatment On Changes In Vitamin D Serum Level Before And After Periodontal Treatment

Protocol summary

Study aim
Determining the effect of chronic periodontitis treatment on the changes in vitamin D serum level before and after periodontal treatment
Design
a single-arm clinical trial with a sample size of 38 patients
Settings and conduct
Patients from the periodontics department of Gilan Dental School are included in the study. Serum vitamin D levels of patients are measured and periodontal Scaling and Root Planing treatment and, if necessary, surgical treatment are performed for patients. 1 month and 3 months after periodontal treatment, the serum level of vitamin D will be measured again and its level will be compared with the level before periodontal treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients with untreated chronic periodontitis and having at least 6 teeth for each patient; Exclusion criteria include having a systemic disease that affects bone metabolism, having a history of cancer, consuming vitamin D and calcium supplements, consuming interfering drugs such as bisphosphonates, barbiturates, cardiac glycosides, cholestyramine, glucocorticoids, and laxatives, being pregnant and has a history of antibiotic therapy and periodontal treatment in the past 6 months.
Intervention groups
First, the indices of probe depth and clinical bone loss, index plate and radiographic bone loss of each patient are recorded. A blood sample is taken from the intervention group, and then periodontal treatment of scaling and leveling of the root surface and, if necessary, surgical treatment such as curettage or grafting are performed. One month later and three months later, the indicators are recorded again and the blood sample is taken from the patient.
Main outcome variables
Serum 25(OH)D3 level; periodontal therapy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240212060975N1
Registration date: 2024-03-02, 1402/12/12
Registration timing: registered_while_recruiting

Last update: 2024-03-02, 1402/12/12
Update count: 0
Registration date
2024-03-02, 1402/12/12
Registrant information
Name
Amin Rajabzadeh Kanafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3348 6418
Email address
a_rajabzadeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-13, 1402/11/24
Expected recruitment end date
2024-07-14, 1403/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Of The Effect Of Chronic Periodontitis Treatment On Changes In Vitamin D Serum Level Before And After Periodontal Treatment
Public title
Evaluation Of The Effect Of Chronic Periodontitis Treatment On Changes In Vitamin D Serum Level Before And After Periodontal Treatment
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with untreated chronic periodontitis Having at least 6 teeth for each patient
Exclusion criteria:
Having a systemic disease that affects bone metabolism Having a history of cancer Taking vitamin D and calcium supplements Users of interfering drugs such as Bisphosphonates, Barbiturates, Cardiac Glycosides, Cholestyramine, Glucocorticoids, and Laxatives Being pregnant Having a history of antibiotic therapy and periodontal treatment in the last 6 months
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 38
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Single-arm Clinical trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gilan University of Medical Sciences
Street address
Guilan University Of Medical Sciences, Namjoo Blv.
City
Rasht
Province
Guilan
Postal code
33697-41938
Approval date
2024-01-31, 1402/11/11
Ethics committee reference number
IR.GUMS.REC.1402.574

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
25(OH)D3 Serum Level
Timepoint
Before periodontal treatment, 1 month after and 3 months after periodontal treatment
Method of measurement
Serum vitamin D level measurement by Razi Pathobiology Laboratory of Rasht

Secondary outcomes

empty

Intervention groups

1

Description
A total of 38 patients with chronic periodontitis with entry criteria from the periodontics department of Gilan Dental School were included in the study. First, the indices of probe depth and clinical bone loss, index plate and radiographic bone loss of each patient are recorded. A blood sample will be taken from the intervention group to evaluate the vitamin D serum level, and then periodontal treatment of scaling and leveling of the root surface and, if necessary, surgical treatment such as curettage or grafting will be performed. One month later and three months later, indicators are recorded again, blood samples are taken from the patient, and the effect of periodontal treatment on changes in vitamin D serum level is checked.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Periodontics of Guilan Faculty of Dentistry
Full name of responsible person
Amin Rajabzadeh Kanafi
Street address
Faculty of Dentistry, Guilan University of Medical Sciences, Fuman-Saravan Rd.
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6407
Email
dental@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ramyar Farzan
Street address
Research Vice-Chancellor of the University, Shahid Siyadati St., Namjoo Blv.
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Amin Rajabzadeh Kanafi
Position
Assistant Professor of Periodontology
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Guilan University of Medical Sciences, Saravan-Fuman Rd., Rasht.
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6418
Fax
Email
a_rajabzadeh@gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Amin Rajabzadeh Kanafi
Position
Assistant Professor of Periodontology
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Guilan University of Medical Sciences, Saravan-Fuman Rd., Rasht.
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6418
Fax
Email
a_rajabzadeh@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Amin Rajabzadeh Kanafi
Position
Assistant Professor of Periodontology
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Guilan University of Medical Sciences, Saravan-Fuman Rd., Rasht.
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6418
Fax
Email
a_rajabzadeh@gums.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
Yes - There is 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
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions can apply to receive data.
Under which criteria data/document could be used
If there are titles in measuring the relationship between microparticles such as vitamin D and diseases such as periodontitis, the results can be used.
From where data/document is obtainable
Applicants can call Yasmin Saadat Rouhi on 09111317821 or send their application to info.saadatrouhi@gmail.com.
What processes are involved for a request to access data/document
The applicant, by calling the mobile number 09111317821 in the name of Yasmin Saadat Rouhi, put forward his request and the conditions of its use and explain in what other conditions there will be for the use of these data or documents. During the call, the requester's email will be received, and after checking, the data files will be emailed to the requester within two to three days.
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