Investigating the effect of vitamin B complement administration on pain and sensory problems following implant surgery in the posterior portion of mandible
Investigating the effect of vitamin B complement administration on pain and sensory problems following implant surgery in the posterior portion of mandible
Design
Clinical trial with parallel intervention group, without blinding, randomized, random sampling method. Randomization method is simple and with a random number table. 46 people will be selected (23 people will receive routine treatment after implantation and 23 people will receive vitamin B complex pills daily for two weeks in addition to routine treatment.
Settings and conduct
The study will be performed in the Periodontics department of Tabriz Dental School. 23 people are prescribed vitamin B complex pills for two weeks (intervention group) in addition to routine treatment, and 23 people are prescribed only routine treatment (control group). The patient is aware of his pills. The incidence of sensory symptoms will be measured.
Participants/Inclusion and exclusion criteria
Entry requirements: Satisfaction to participate in the study, Sensory disorder and unilateral pain in the mandible because of the implant placement, Healthy patients without the use of special drugs. Exit conditions: Previous history of inferior alveolar nerve injury, Inability of the patient to follow the treatment and clinical examinations of the study, Patients with clinical and radiographic symptoms indicating nerve damage due to implant or instrument invasion of the nerve canal .
Intervention groups
46 patients will be divided into two groups. In addition to routine treatment, the intervention group will receive one vitamin B tablet daily for two weeks, and the control group will receive only routine post-implant treatment.
Main outcome variables
Pain and numbness after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180630040290N5
Registration date:2020-09-03, 1399/06/13
Registration timing:registered_while_recruiting
Last update:2020-09-03, 1399/06/13
Update count:0
Registration date
2020-09-03, 1399/06/13
Registrant information
Name
Amir Reza Babaloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3428 3025
Email address
babalooa@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-09-10, 1399/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of vitamin B complement administration on pain and sensory problems following implant surgery in the posterior portion of mandible
Public title
Evaluation of the effect of vitamin B supplementation on pain caused by implant surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Sensory disorder and unilateral pain in the mandible due to the implant placement
Healthy patients without the use of special drugs
Exclusion criteria:
Inability of the patient to follow the treatment and clinical examinations of the study
Previous history of inferior alveolar nerve injury
People with primary neurological problems such as neuropathies and paresthesia
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method is randomly available among individuals referring to periodontics department of Tabriz dental faculty. The randomization method is simple and the unit is individual, our tool for randomization is the randomized number chart. Furthermore, the allocation of treatment to patients is done randomly. To do this, the types of the treatment are identified with code A (prescribing vitamin B) and B (not prescribing vitamin B) and then the treatment are sealed in envelopes that will be placed in a box and stirred. Then they are randomly chosen from the box and after observing the code, the treatment is given to the patient.
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 Tabriz University of Medical Sciences
Street address
Central office of Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Approval date
2020-08-24, 1399/06/03
Ethics committee reference number
IR.TBZMED.REC.1399.551
Health conditions studied
1
Description of health condition studied
Mandibular implants
ICD-10 code
Z96.5
ICD-10 code description
Presence of tooth-root and mandibular implants
Primary outcomes
1
Description
Pain after surgery
Timepoint
It will be done 14, 28 days and 1, 2 and 3 months after receiving treatment.
Method of measurement
Visual Analogue Scale
2
Description
Postoperative malaise
Timepoint
It will be done 14, 28 days and 1, 2 and 3 months after receiving treatment.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine treatment, the intervention group will receive vitamin B complex -50 milligram tablets daily for two weeks , immediately after implantation.
Category
Treatment - Other
2
Description
Control group: Patients in the control group will receive routine post-implant treatment .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences Dentistry Faculty Periodontics Department
Full name of responsible person
Amirreza Babaloo
Street address
Dentistry Faculty of Tabriz, Golgasht Ave, Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
amirrezababaloo@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Central office No. 2, Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Web page address
https://researchvice.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amir reza Babaloo
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
amirezababaloo@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amir reza Babaloo
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
amirezababaloo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amir reza Babaloo
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
amirezababaloo@yahoo.com
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