Comparing the Effect of Short-Term Use of Vitamin D with Vitamin D Plus Calcium Supplement in Treatment of Patients with Periodontitis Referred to Qom Dental School from 2021 to 2022
Determine the impact of Short-Term Use of Vitamin D with Vitamin D Plus Calcium Supplement in Treatment of Patients with Periodontitis Referred to Qom Dental School from 2021 to 2022
Design
The clinical trial has a control group based on parallel groups. Assignment of patients to three groups receiving vitamin D and SRP, vitamin D and calcium and SRP and SRP will be done by block method alone and using 6 blocks.
Settings and conduct
Individuals who have referred to the periodontics department of Qom Dental School will enter the study after obtaining informed consent.
Participants/Inclusion and exclusion criteria
Inclusion criteria: people with an average age of 20 to 70 years old. They have more than 20 teeth left in his mouth. At least two interproximal areas with CAL (clinical attachment level) more than 3 mm. Exclusion criteria: people with systemic problems such as diabetes, hypothyroidism or hyperthyroidism and any endocrine-related diseases. Severe systemic diseases such as cancer. Consumption of vitamin D and calcium during the three months before the study. Pregnancy and lactation. People who have received non-surgical periodontal treatment or periodontal surgery in the past year. Use of antibiotics and immunosuppressive drugs that affect the metabolism of vitamin D and calcium.
Intervention groups
Interventions: patients with chronic periodontitis whose vitamin level is less than 32 ng / ml are included in the study. For all patients, Scaling & Root Planning of the whole mouth and then health education is done similarly by flossing and brushing with modified Bass. Then, after two weeks, the first group is given 50,000 IU weekly vitamin D and 1,000 mg of daily calcium supplement, and the second group is given only 50,000 IU weekly vitamin D for 3 months, and the third group as the control group is not given any medication.
Main outcome variables
Periodontal clinical parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210510051255N1
Registration date:2021-07-05, 1400/04/14
Registration timing:registered_while_recruiting
Last update:2021-07-05, 1400/04/14
Update count:0
Registration date
2021-07-05, 1400/04/14
Registrant information
Name
Fateme Abedini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3660 2455
Email address
dentistryabedini74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Short-Term Use of Vitamin D with Vitamin D Plus Calcium Supplement in Treatment of Patients with Periodontitis Referred to Qom Dental School from 2021 to 2022
Public title
Comparing the Effect of Short-Term Use of Vitamin D with Vitamin D Plus Calcium Supplement in Treatment of Patients with Periodontitis Referred to Qom Dental School from 2021 to 2022
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with an average age of 20 to 70 years old
They have more than 20 teeth left in his mouth
At least two interproximal areas with CAL (clinical attachment level) more than 3 mm.
Exclusion criteria:
People with systemic problems such as diabetes, hypothyroidism or hyperthyroidism and any endocrine-related diseases
Severe systemic diseases such as cancer
Consumption of vitamin D and calcium during the three months before the study
Pregnancy and lactation
People who have received non-surgical periodontal treatment or periodontal surgery in the past year
Use of antibiotics and immunosuppressive drugs that affect the metabolism of vitamin D and calcium
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Assigning patients to three groups receiving vitamin D and SRP, vitamin D and calcium, and SRP and SRP alone.It will be done by blocking method and using 6 blocks.
Patients are divided into three groups using a randomized balanced block method with a block size of 6. A random sequence is created by an epidemiologist by running an online application on the website (https://www.sealedenvelope.com)
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 Qom University of Medical Sciences
Determination of plaque score according to O’Leary method
5
Description
Gingival index
Timepoint
Baseline, three months later
Method of measurement
Observation
Secondary outcomes
1
Description
25-hydroxyvitamin D
Timepoint
During the study
Method of measurement
Venous blood sampling
Intervention groups
1
Description
The first Intervention group: Scaling & Root Planning of the whole mouth and then hygiene training is done similarly by flossing and brushing with the modified Bass method. After two weeks of SRP, Prescribe 50,000 IU of vitamin D weekly and 1,000 mg of calcium supplement daily.
Category
Treatment - Drugs
2
Description
The second intervention group: Scaling & Root Planning of the whole mouth and then hygiene training is done similarly by flossing and brushing with the modified Bass method. After two weeks of SRP, Prescribe 50,000 IU of vitamin D weekly.
Category
Treatment - Drugs
3
Description
Control group: Scaling & Root Planning of the whole mouth and then hygiene training is done similarly by flossing and brushing with the modified Bass method. No medication is prescribed for this group as a control group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom Dental School-Periodontics depatment
Full name of responsible person
Dr.Leila Khodadadifard
Street address
Qom School of Dentistry, Lavasani St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 0095
Email
l.khodadadifard@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr. Ehsan Sharifipoor
Street address
No 83, Jihad Daneshgahi Alley, Shahid Lotfi Niasar (Alley No. 4), Safashahr St.
City
Qom
Province
Ghoum
Postal code
37169-93456
Phone
+98 25 3285 2720
Email
research@mail.muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
80
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
Ghoum University of Medical Sciences
Full name of responsible person
Fateme Abedini
Position
Dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Qom Dental School, Shahid Lavasani St.
City
Qom
Province
Ghoum
Postal code
39367-37136
Phone
+98 25 3770 3738
Email
dentistryabedini74@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr. Leila Khodadadifard
Position
Periodontist, Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qom Dental School, Lavasani St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 0095
Email
l.khodadadifard@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Fateme Abedini
Position
Dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Qom Dental School, Shahid Lavasani St.
City
Qom
Province
Ghoum
Postal code
39367-37136
Phone
+98 25 3770 3738
Email
dentistryabedini74@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after unidentified individuals
When the data will become available and for how long
access the data 6month after the result are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
People working on patients with periodontitis or vitamin D deficiency
From where data/document is obtainable
Applicants can apply via the following e-mail to receive the required documents or data
dentistryabedini74@gmail.com
What processes are involved for a request to access data/document
Email to the project presenter-Request from the Vice Chancellor for Research-If positive, provide information to the applicant