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The effectiveness of Vitamin C on the Level of Salivary Total Antioxidant Capacity(TAC) in bruxism patients

Protocol summary

Study aim
Evaluation the effectiveness of Vitamin C on the level of Total Antioxidant Capacity (TAC) in bruxism patients
Design
This clinical trial with a sample size of 30 people was a three-phase, double-blind study with parallel groups. Block randomization was performed in six-piece block individually by a sealed envelope. The random sequence was determined by draw.
Settings and conduct
The study population was patients with bruxism of Dentistry Faculty of Tehran University of Medical Sciences in international campus branch. After the examination, completing the questionnaire, and evaluating the patients’ pain severity by numerical rating scale, 1 mm non- excitatory and excitatory saliva was collected from the patients. Then, 250 mg vitamin C was prescribed for the intervention group and one daily was given to the placebo control group. Eventually, after a month, their pain was measured and their excitatory and non- excitatory saliva was collected.In order to blinding, the medications were put into boxes of one color and one form, and the difference was the code on which they were inserted; the list was kept by clinical caregiver until decoded. The patient,researcher, outcome evaluator, and data analyzer are kept compared to the blinded study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: symptoms of grinding teeth on each other, discomfort and fatigue, increase in the size of masticatory muscles. toothpicking, recurrent migraines ,broken dental fillings or splint, ulceration of denture underlying mucosa and sensitivity to percussion. Exclusion criteria: consumption of alcohol and cigarettes and specific medications, systemic problems (diseases of kidney and liver, thyroid and diabetes) and cancer
Intervention groups
This study was conducted on a control group of 15 patients with placebo and the intervention group of 15 patients with vitamin C.
Main outcome variables
Total Antioxidant Capacity of stimulated and unstimulated saliva of patient

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160903029651N2
Registration date: 2018-03-04, 1396/12/13
Registration timing: retrospective

Last update: 2018-03-04, 1396/12/13
Update count: 0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
hodays yeganehfard
Name of organization / entity
Tehran University of Medical Sciences Faculty of Dentistry international campus
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 6837
Email address
yhodais@yahoo.com
Recruitment status
Recruitment complete
Funding source
Research Center School of Tehran Dentistry Faculty
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2017-11-22, 1396/09/01
Trial completion date
empty
Scientific title
The effectiveness of Vitamin C on the Level of Salivary Total Antioxidant Capacity(TAC) in bruxism patients
Public title
The effect of Vitamin C on salivary antioxidant level in patients with bruxism (gnash)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Our diagnostic criteria for bruxism is considered based on ICSD-R: 1. Symptoms indicating grinding teeth on each other while sleeping 2. Abnormal grinding of teeth 3. Sound of grinding teeth 4. Discomfort of jaw muscle As well as other symptoms stated by Murali: 1. Toothpicking 2. Fatigue of masticatory muscles 3. Recurrent migraines 4. Broken Dental fillings or splint 5.Ulceration of denture underlying mucosa 6. Sensitivity to percussion 7. Increase in the size of the Temporal and Masseter muscles
Exclusion criteria:
Those who have the following features are removed from the list: 1. Record of severe trauma and dental surgeries 2. Clinical record of functional disorder (depression and anxiety)and sleep disorders (Apnea and Insomnia) 3. Moderate to high consumption of alcohol and cigarettes 4. Systemic problems (diseases of kidney and liver, thyroid and diabetes) and cancer, pregnant and nursing mothers 5. Taking drugs (Glucocorticoids or Selective Serotonin, edible contraceptives, variety of Antioxidants,Folic acid, Allopurinol such as Zenthine Oxidase Inhibitor) 6. Epilepsy or neurological disorders such as Parkinson’s and Alzheimer’s 7. Infectious diseases 8. Those who had taken muscle relaxing drugs such as Benzodiazepines 9. Neuromuscular disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization was done individually through a sealed envelope and the manner of creating random sequences was through draw.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blinding, the medications were put into boxes of one color and one form, and the difference was the code on which they were inserted; the list was kept hidden by clinical caregiver until decoded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Dentistry school of Tehran university of medical science
Street address
Tehran University of Medical Sciences of Dentistry School, next to Hakim Highway, up to Atomic Energy Organization, end of Kargar Shomali
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2017-10-21, 1396/07/29
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1396.3757

Health conditions studied

1

Description of health condition studied
bruxism
ICD-10 code
F45.8
ICD-10 code description
Any other disorders of sensation, function and behaviour, not due to physical disorders, which are not mediated through the autonomic nervous system, which are limited to specific systems or parts of the body, and which are closely associated in time with

Primary outcomes

1

Description
Changes the level of Total Antioxidants Capacity (TAC) of stimulated and unstimulated saliva
Timepoint
Before intervention and one month after
Method of measurement
Taking 1 ml stimulated and unstimulated saliva samples and measurement of total antioxidant capacity by the ZellBio GmBh (CAT No. ZB-TAC-96A) and (CAT No. ZB-TAC-48A) kits through oxidation-reduction calorimetry

Secondary outcomes

1

Description
The score of myofascial pain associated with bruxism
Timepoint
Before intervention and one month after
Method of measurement
Numeric Scale Rating (NRS)

Intervention groups

1

Description
Chewing Vitamin C 250 mg/day with the taste of cherry of Osweh Companyو chew one of them daily for a month in the morning (30 days).
Category
Treatment - Drugs

2

Description
Chewing Placebo (Similst to Vitamin C)250 mg/day with the taste of cherry of Osweh Company, chew one of them daily for a month in the morning (30 days).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
International Campus Branch, Tehran University of Medical Sciences, School of Dentistry
Full name of responsible person
Hodays Yeganehfard
Street address
International Campus Branch,Tehran University of Medical Sciences,School of Dentistry, opposite the Shariati Boostan, Mahan St., Khani Abad Ave.
City
Tehran
Province
Tehran
Postal code
1894787549
Phone
+98 21 5585 1151
Email
Yhodais@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
International Campus Branch, Tehran University of Medical Sciences, School of Dentistry
Full name of responsible person
Shamsoulmolouk Najafi
Street address
International Campus Branch, Tehran University of Medical Sciences, School of Dentistry, opposite the Shariati Boostan, Mahan St., Khani Abad Ave.
City
Tehran
Province
Tehran
Postal code
1894787549
Phone
+98 21 5585 1149
Email
Najafi_sh@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Campus Branch, Tehran University of Medical Sciences, School of Dentistry
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
International Campus Branch, Tehran University of Medical Sciences, School of Dentistry
Full name of responsible person
Shamsoulmolouk Najafi
Position
mouth disease specialist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
International Campus Branch, Tehran University of Medical Sciences, School of Dentistry, opposite the Shariati Boostan, Mahan St., Khani Abad Ave.
City
Tehran
Province
Tehran
Postal code
1894787549
Phone
+98 21 5585 1149
Fax
Email
Najafi_sh@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
International Campus Branch, Tehran University of Medical Sciences, School of Dentistry
Full name of responsible person
Shamsoulmolouk Najafi
Position
mouth disease specialist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
International Campus Branch, Tehran University of Medical Sciences, School of Dentistry, opposite the Shariati Boostan, Mahan St., Khani Abad Ave.
City
Tehran
Province
Tehran
Postal code
1894787549
Phone
+98 21 5585 1149
Fax
Email
Najafi_sh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
International Campus Branch,Tehran University of Medical Sciences, School of Dentistry
Full name of responsible person
Hodays Yeganehfard
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
International Campus Branch, Tehran University of Medical Sciences, School of Dentistry, opposite the Shariati Boostan, Mahan St., Khani Abad Ave.
City
Tehran
Province
Tehran
Postal code
1894787549
Phone
+98 21 5585 1149
Fax
Email
Yhodsais@yahoo.com
Web page address

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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
In the Effect of vitamin C in the level of total antioxidant saliva in patients with bruxism and the consequences resulting from it such as pain relief, only part of the data, such as information on the primary and secondary consequences, can be shared.
When the data will become available and for how long
It will be available one year after publishing
To whom data/document is available
Researchers working in the field of dentistry and medicine
Under which criteria data/document could be used
Any analysis of the data is not allowed and only the documentation is used to obtain its results in order to help other studies.
From where data/document is obtainable
Doctor Shamsoulmolouk Najafi, Najafi_sh@tums.ac.ir Hodays Yeganehfard, Yhodais@yahoo.com
What processes are involved for a request to access data/document
At first, an email is sent to the requested people and we waited 3 to 10 days to submit the file
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