Protocol summary

Study aim
Investigating the effect of vitamin 3D on the average clinical indicators of chronic periodontitis in the group consuming vitamin D3 and the placebo group
Design
A controlled, parallel-group, double-blind, randomized, phase 4 clinical trial on 32 patients. Random allocation software was used for randomization.
Settings and conduct
This study is a double-blind randomized clinical trial study after the proposal was approved by the Research Council of the Yazd School of Dentistry with a sample size of 32 people in the age group of 30 to 45 years with periodontitis stage 1 and 2 and vitamin D3 deficiency from patients referred to Yazd Faculty of Dentistry is done. The samples will be divided into two experimental and control groups. The experimental group will be given oral vitamin 3D supplement and the control group will be given placebo. After three months, the indicators of bleeding after probing (BOP), pocket depth (PD), clinical adhesion loss (CAL) will be compared in two groups.
Participants/Inclusion and exclusion criteria
Entry criteria: female should be healthy, between 30 and 45 years old, have at least 20 teeth and levels below 30 ng/ml. Inclusion criteria: no recent antibiotic treatment, vitamin D supplements, corticosteroids or immunosuppressive drugs, aspirin use, NSAID use, bisphosphonates or hormone therapy, patients who were in menopause, patients who were pregnant, patient with a history of infective endocarditis, congenital problem or acquired heart defects, immunodeficiency, history of diabetes, calcium deficiency, bone diseases or other systemic conditions that may affect the periodontium and the treatment protocol
Intervention groups
Intervention group: the group receiving vitamin d3 soft gel 4000 IU. Control group: the group receiving placebo soft gel without active ingredient.
Main outcome variables
clinical attachment loss; probing depth; bleeding on probing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221212056786N3
Registration date: 2023-11-05, 1402/08/14
Registration timing: prospective

Last update: 2023-11-05, 1402/08/14
Update count: 0
Registration date
2023-11-05, 1402/08/14
Registrant information
Name
Seyed mohammad Arab farashahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3621 2222
Email address
sm.arab@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-11, 1402/09/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of vitamin D3 in improvement clinical parameters of patients with chronic periodontitis-clinical trial
Public title
Evaluation the effect of vitamin D3 in improvement clinical parameters of patients with chronic periodontitis-clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female Has at least 20 teeth Blood vitamin D levels below 30 ng/ml (normal level is ≥ 30 ng/ml). Healthy Between 30 and 45 years
Exclusion criteria:
Recent antibiotic therapy Taking vitamin D supplements Use of corticosteroids or immunosuppressive drugs Taking aspirin tablets NSAID use Taking bisphosphonates or hormone therapy Patients who were in menopause or pregnancy Bone diseases Patient with history of infective endocarditis, congenital problem or acquired heart defects Immunodeficiency History of diabetes Calcium deficiency Other systemic conditions that may affect the periodontium and the treatment protocol
Age
From 30 years old to 45 years old
Gender
Female
Phase
4
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients are placed in two groups using Random Allocation software version 1.0 under Windows and stratified in a simple random manner based on age so that the two groups are the same in terms of age.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the study participants and the researcher will be unaware of the division of patients into experimental and control groups, and only a third person outside the study will be aware of the division method. (double-blinding) Vitamin 3D supplement and placebo will be provided to patients in the same containers. (so that the contents of the containers are not visible from the outside)
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشکده دندان پزشکی _ دانشگاه علوم پزشکی شهید صدوقی یزد
Street address
Yazd-Imam Street-Beginning of Daheh Fajr Boulevard-Shahid Sadoughi Dental School, Yazd
City
yazd
Province
Yazd
Postal code
8914881167
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1401.095

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
clinical attachment loss
Timepoint
At the beginning of the study and 12 weeks after the start of vitamin D intake
Method of measurement
Williams periodontal probe

Secondary outcomes

1

Description
probing depth
Timepoint
At the beginning of the study and 12 weeks after the start of vitamin D intake
Method of measurement
Williams periodontal probe

2

Description
Bleeding on probing
Timepoint
At the beginning of the study and 12 weeks after the start of vitamin D intake
Method of measurement
Williams periodontal probe

Intervention groups

1

Description
Intervention group: The ingredient used is vitamin D3 4000 soft gel in yellow color. Two 4000 IU vitamin D3 oral supplement capsules (Dana Pharmaceutical Company product) daily, one in the morning and one at night, will be given to the patients of this group every day (seven days a week) for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: They will receive the placebo in the form of a soft gel without the active ingredient, which is similar in size and color to vitamin D3. The patient should take one pill in the morning and one pill at night, every day (seven days a week) for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Faculty of Dentistry, Yazd
Full name of responsible person
seyed mohammad arab farashahi
Street address
Yazd-Imam Street-Beginning of Daheh Fajr Boulevard-Shahid Sadoughi Dental School, Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 2222
Email
Sm.arab@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
seyed mohammad arab farashahi
Street address
Yazd-Imam Street-Beginning of Daheh Fajr Boulevard-Shahid Sadoughi Dental School, Yazd
City
yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 2222
Email
Sm.arab@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
mina zamani
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Yazd-Imam Street-Beginning of Daheh Fajr Boulevard-Shahid Sadoughi Dental School, Yazd
City
yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 2222
Email
miina.zmn99@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed mohammad Arab farashahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Yazd school of dentistry, emam reza blvd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 2222
Fax
Email
Sm.arab@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed mohammad Arab farashahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Yazd school of dentistry, emam reza blvd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3621 2222
Fax
Email
Sm.arab@ssu.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
Loading...