Effect of vitamin D3 versus not receiving vitamin D3 on the inflammation and complications after hidden third molar surgery in mandible in patients with vitamin D3 deficiency: a randomized clinical trial
To assess the effect of vitamin D3 versus not receiving vitamin D3 on the inflammation and complications after hidden third molar surgery in the mandible
Design
This is a randomized clinical trial, phase II, in which 30 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with vitamin D3 deficiency who are the candidate for hidden third molar surgery in the mandible and will refer to School of Dentistry during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 40 years;
Candidate for third molar surgery in mandible;
Vitamin D3 deficiency
Exclusion criteria:
Narcotic addiction;
Cigarette smoking;
Diabetes;
Renal failure;
Bowel inflammatory disease
Intervention groups
Intervention group 1: Hidden third molar surgery in mandible in one side by random without receiving vitamin D3
Intervention group 2: Hidden third molar surgery in mandible in the other side 10 days after the first surgery plus tablet vitamin D 0.25 mg once daily for 3 months and ampulla vitamin D 300,000 IU once a month for 3 months
Main outcome variables
Primary outcome:
Cheek inflammation
Mouth opening
Pain on surgery location
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N227
Registration date:2018-07-25, 1397/05/03
Registration timing:retrospective
Last update:2018-07-25, 1397/05/03
Update count:0
Registration date
2018-07-25, 1397/05/03
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-01, 1396/12/10
Expected recruitment end date
2018-06-18, 1397/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D3 versus not receiving vitamin D3 on the inflammation and complications after hidden third molar surgery in mandible in patients with vitamin D3 deficiency: a randomized clinical trial
Public title
Effect of vitamin D3 versus not receiving vitamin D3 on the inflammation and complications after hidden third molar surgery in mandible in patients with vitamin D3 deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years;
Candidate for third molar surgery in mandible;
Vitamin D3 deficiency
Choosing the third molar of the mandible in either side of the patient by throwing the coin
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.UMSHA.REC.1396.818
Health conditions studied
1
Description of health condition studied
Vitamin D deficiency
ICD-10 code
E50
ICD-10 code description
Vitamin D deficiency
Primary outcomes
1
Description
Cheek inflammation
Timepoint
1, 3, 7, and 10 days after surgery
Method of measurement
By physical examination
2
Description
Mouth opening
Timepoint
1, 3, 7, and 10 days after surgery
Method of measurement
By physical examination
3
Description
Pain on surgery location
Timepoint
1, 3, 7, and 10 days after surgery
Method of measurement
By visual analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Third molar surgery in mandible in one side by random without receiving vitamin D3
Category
Treatment - Surgery
2
Description
Intervention group 2: Third molar surgery in mandible in the other side 10 days after the first surgery plus tablet vitamin D 0.25 mg once daily for 3 months and ampulla vitamin D 300,000 IU once a month for 3 months
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Golnaz Ziaee
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
goli0311@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Golnaz Ziaee
Position
Dental Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
goli0311@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Amir Hosein Babaee Soroor
Position
Oral, Maxillofacial Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dr.amirsoroor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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