1. Home
  2. Approved trials
  3. » فارسی

Local clinical effect of simvastatin tablets on pain after maxillary premolar tooth extraction in patients recommended for orthodontic treatment

Protocol summary

Study aim
Clinical Effect of Simvastatin Tablets on Reducing Pain After Extracted Maxillary Maxillary Teeth in Patients Referring to Orthodontic Treatments
Design
Clinical trial with control group, with parallel groups, one blind, randomized
Settings and conduct
This research was carried out in the surgery department of Mazandaran Dental School, and the whole process of removing the teeth, inserting the simvastatin drug into silence and suturing, was done by one person (designer).
Participants/Inclusion and exclusion criteria
Patients with systemic problems, or certain drugs, as well as addicts and smokers were excluded from the study and only healthy patients were examined. The criteria for entering the study include the age range of 18-35 years, and the orthodontic order to remove any of the two first premolars for future orthodontic treatment. Also, the teeth should not have periapical radiographic changes and caries, and they should also be removed by local anesthetic and non-surgical forceps and anesthesia.
Intervention groups
To assign each pair to the control or intervention group based on the first or second time, using the random numbers table, 10 people were assigned to the intervention group
Main outcome variables
The findings of this study indicate that in general, the pain level in the local consumption group of simvastatin was significantly higher than the control group at all times than 6 hours after tooth extraction, which is statistically significant have been. There is also no relationship between sex and age with the amount of pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190701044070N1
Registration date: 2019-07-06, 1398/04/15
Registration timing: retrospective

Last update: 2019-07-06, 1398/04/15
Update count: 0
Registration date
2019-07-06, 1398/04/15
Registrant information
Name
sanaz akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4426 7456
Email address
sanazkbr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-28, 1397/08/06
Expected recruitment end date
2019-03-13, 1397/12/22
Actual recruitment start date
2018-10-28, 1397/08/06
Actual recruitment end date
2019-03-13, 1397/12/22
Trial completion date
2019-03-13, 1397/12/22
Scientific title
Local clinical effect of simvastatin tablets on pain after maxillary premolar tooth extraction in patients recommended for orthodontic treatment
Public title
The effect of simvastatin on reducing tooth pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The orthodontic order to extract of each 2 maxillary premolars for future orthodontic treatment
Exclusion criteria:
Age
From 18 years old to 35 years old
Gender
Both
Phase
0
Groups that have been masked
  • Participant
Sample size
Target sample size: 10
More than 1 sample in each individual
Number of samples in each individual: 2
First maxillary premolar teeth on the left and the right
Actual sample size reached: 10
More than 1 sample in each individual
Actual sample size in each individual: 2
First maxillary premolar teeth on the left and the right
Randomization (investigator's opinion)
Randomized
Randomization description
To assign each pair to the control group or the intervention based on the first or second time, using the random numbers table, 10 people will be assigned to the intervention group and 10 will be assigned to the control group. Patients with systemic problems, or certain drugs, as well as addicts and smokers will be removed from the study group, and only healthy patients will be examined. The criteria for entering the study can be from the age of 35 to 18 years, and the orthodontic order for the removal of each of the first two premolars in the right and left upper jaw. Also, the teeth should not have periapical radiographic changes and can also be removed by forceps and local anesthetics. The pain according to the patient's own opinion, based on the subjective criteria and according to the Visual Analog Scale (VAS), will be available at the intervals before, 30 minutes later, 6 hours, 12 hours and 24 hours after surgery. . In addition, the patient is urged to visit the department 7 days a day to examine and pull sutures.
Blinding (investigator's opinion)
Single blinded
Blinding description
This clinical trial is parallel, randomized, and blind clinical trials. In the intervention group, the gelatin sponge coated with simvastatin (10 mg, combined with saline) (Poursina, Tehran, Iran) was placed in silence and then sutured with suture wrap 3 to 3 vikril. In the control group, just after washing, only gelatin sponge is placed and the silent just sutures.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
empty

2

Registry name
Secondary trial Id
Registration date
empty

3

Registry name
Secondary trial Id
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
medical university of mazandaran, Vali asr Ave., sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2019-04-08, 1398/01/19
Ethics committee reference number
IR.MAZUMS..REC13983394

Health conditions studied

1

Description of health condition studied
tooth pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The amount of pain
Timepoint
Before, 30 minutes later, 6 hours, 12 hours and 24 hours after surgery
Method of measurement
The VAS is a 10-cm linear scale that is graded from zero to ten and is zero in the no-pain sense and ten most severe pain. After considering the line, the patient determines the amount of pain on the line, and then the pain is calculated based on millimeters from the origin of zero.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first premolar was the one used with simvastatin
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry Sari
Full name of responsible person
Dr. Reza Mofidian
Street address
Mazandaran University of Medical Sciences and Health Services, Beginning of Valiasr highway, Sari, Mazandaran
City
sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3304 4001
Email
ict@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Reza Mofidian
Street address
Mazandaran University of Medical Sciences and Health Services, Beginning of Valiasr highway, Sari, Mazandaran
City
sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3304 4001
Email
ict@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Reza Mofidian
Position
University teacher
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mazandaran University of Medical Sciences and Health Services, Beginning of Valiasr highway, Sari, Mazandaran
City
sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3304 4001
Email
reza_mofidian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Reza Mofidian
Position
teacher of university
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mazandaran University of Medical Sciences and Health Services, Beginning of Valiasr highway, Sari, Mazandaran
City
sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3304 4001
Email
reza_mofidian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Reza Mofidian
Position
teacher of university
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mazandaran University of Medical Sciences and Health Services, Beginning of Valiasr highway, Sari, Mazandaran
City
sari
Province
Mazandaran
Postal code
48157-33971
Phone
+1 33044001
Email
sanazkbr@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
Clinical Effect of Simvastatin Tablets on the Post-Injury of Premolar Maxillary Pain in Patients Referring to Orthodontic Treatments
When the data will become available and for how long
It's ready
To whom data/document is available
University - Supervisor - Student
Under which criteria data/document could be used
To reduce tooth pain and under any circumstances
From where data/document is obtainable
Student
What processes are involved for a request to access data/document
University permit - Propeller - Research - Conclusion - Thesis
Comments
Loading...