Determining and comparing the effect of placing Simvastatin and platelet rich fibrin on the level of pain and the quality of bone formed in the socket of extracted teeth.
Design
A single-blind, parallel-group, randomized clinical trial on 19 patients. Randomization is done using a table of random numbers.
Settings and conduct
The selected patients need to have two teeth extracted on both sides of the jaw and are candidates for implant treatment. Silent selection is randomized to platelet-rich fibrin (PRF) or Simvastatin. The sample size of 38 people in two groups of 19 is randomly selected with a table of random numbers. The ingredients are placed in absorbable collagen (Gelfoam) and the patient does not know about the ingredients. After tooth extraction, we put PRF on one side and Simvastatin on the other side. 3 months later, for implant treatment, sampling is done and interpreted by light microscope. In the current study, the information that can distort the results of the intervention (such as the type, shape, color, smell, and method of intervention treatment) is hidden from the participant.
Participants/Inclusion and exclusion criteria
Including criteria is patients candidate for implant replacement of two similar hopeless tooth of both sides of a jaw, between age 20 to 65 years old. Excluding criteria is systemic diseases, the use of steroids, history of radiotherapy, diabetes, pregnancy, smoking, periodontal disease and allergy.
Intervention groups
The intervention group includes patients who need tooth extraction for implant treatment and who receive PRF intervention.
The comparison group includes patients who need tooth extraction for implant treatment and receive Simvastatin intervention.
Main outcome variables
bone quality; felt pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171015036782N10
Registration date:2024-09-27, 1403/07/06
Registration timing:prospective
Last update:2024-09-27, 1403/07/06
Update count:0
Registration date
2024-09-27, 1403/07/06
Registrant information
Name
farzane vaziri
Name of organization / entity
Shahid sadoughi dental university
Country
Iran (Islamic Republic of)
Phone
+98 35 3620 4764
Email address
f.vaziri@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-06, 1403/07/15
Expected recruitment end date
2025-02-03, 1403/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the quality of formed bone and pain after use of platelet rich fibrin (PRF) and Simvastatin in the extracted tooth socket
Public title
Evaluation the effect of Simvastatin and platelets rich fibrin in the socket of extracted teeth.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 20 to 65 years old
candidate for implant insertion of both sides of a jaw
two similar hopeless tooth of both sides of a jaw
Exclusion criteria:
Pregnancy
Smoking
Using immunosuppressive medications
Uncontrolled diabetes
Systemic disease
History of radiotherapy
Allergy
Periodontal disease
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
19
More than 1 sample in each individual
Number of samples in each individual:
2
split mouth
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomizing the samples is done using a table of random numbers. In order to hide the random allocation, the method of using a non-transparent sealed envelope is also used. In this way, two envelopes are prepared with aluminum fibers (in order to make the contents of the envelopes unclear) and each of the random intervention methods is recorded on a card and the cards are placed inside the envelopes in order. At the start of the intervention, based on the order of the intervention, one of the letter envelopes is opened and its assigned group is revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants will not be aware of the type of prescribed drug
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of yazd University of Medical Sciences
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Yazd
Postal code
8916147860
Approval date
2023-07-31, 1402/05/09
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1402.032
Health conditions studied
1
Description of health condition studied
Loss of teeth due to accident, extraction or local periodontal disease
ICD-10 code
K08.1
ICD-10 code description
Complete loss of teeth
Primary outcomes
1
Description
percentage of vital bone
Timepoint
3 months after tooth extraction at the time of the implant surgery, samples will be taken.
Method of measurement
light microscope
Secondary outcomes
1
Description
pain
Timepoint
1 and 7 days after the extractions, pain will be measured.
Method of measurement
Visual Analogue Scale
2
Description
non-vital bone
Timepoint
3 months after tooth extraction at the time of the implant surgery, samples will be taken.
Method of measurement
light microscope
3
Description
percentage of amorphous bone
Timepoint
3 months after tooth extraction at the time of the implant surgery, samples will be taken.
Method of measurement
light microscope
4
Description
Percentage of trabecular bone
Timepoint
3 months after tooth extraction at the time of the implant surgery, samples will be taken.
Method of measurement
light microscope
Intervention groups
1
Description
Intervention group: Platelet-rich fibrin extracted from 40 cc of the patient's own blood, topically in extracted tooth socket.The blood extracted from the patient is immediately placed in a centrifuge and after separating the platelets rich fibrin (PRF) along with absorbable collagen, placed in the dental socket.
Category
Other
2
Description
Intervention group: Simvastatin 20 mg manufactured by Tehran Chemical Company with the brand name Sivesterol 20, topically in extracted tooth socket. Simvastatin is powdered and then placed inside the socket of the extracted tooth by absorbable collagen.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Faridoddin Fani
Street address
Shahid Sadoughi Faculty of Dentistry Yazd, Emam Reza square
City
yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
faridf2171@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alireza Danesh Kazemi
Street address
Shahid Sadoughi Faculty of Dentistry Yazd, Emam Reza Square
City
yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
faridf2171@gmail.com
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
Faridoddin Fani
Position
Post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
yazd
Province
Yazd
Postal code
8916147860
Phone
+98 35 3830 1323
Email
faridf2171@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Faridoddin Fani
Position
Post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
yazd
Province
Yazd
Postal code
8916147860
Phone
+98 35 3830 1323
Email
faridf2171@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Faridoddin Fani
Position
Post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
yazd
Province
Yazd
Postal code
8916147860
Phone
+98 35 3830 1323
Email
faridf2171@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
Data sets used and/or analyzed during the present study are available from the corresponding author upon request.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Data sets used and/or analyzed during the present study are available from the corresponding author upon request.
From where data/document is obtainable
In order to receive data/documents, you can contact the author of this study through the e-mail address faridf2171@gmail.com.
What processes are involved for a request to access data/document
By sending an email to the responsible author and explaining about the applicant's project proposal and how to use the information, the requested information will be available to the applicant after 10 days after approval by the responsible author.