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Investigating the effect of simvastatin and collogen on the healing condition of extracted tooth socket (histomorphometric evaluation).

Protocol summary

Study aim
Determining effect of simvastatin with collagen compared to collagen on the healing of extracted tooth socke
Design
Controlled clinical trial, with two-arm parallel-group, single-blinded, randomized, on 40 patients
Settings and conduct
Patients referring to the dental faculty of Shahid Sadoughi Yazd university of medical science are chosen if they have the inclusion criteria. Patients are divided into two intervention and control groups based on a table of random numbers. In group A, as a control group, after tooth extraction and socket washing with normal saline and inserting collagen, suturing was performed. Groups B include those who receive Simvastatin, and then sutured Hidden X suture with 4-0 silk and needle 19. For the single-blinding of the study, the primary and secondary outcomes are evaluated by one of the project partners.
Participants/Inclusion and exclusion criteria
Patients with not-restorable or crowned teeth, with root fractures and extensive decay, with residual roots without apical lesions, dental atraumatic extraction, and healthy individuals are the inclusion criteria. Smokers, pregnant and lactating women, a history of radiation therapy and chemotherapy, sensitivity to statin drugs are exclusion criteria.
Intervention groups
.Patients are divided into 2 groups. Group A, as control group receive collagen and group B receive Simvastatin and collagen
Main outcome variables
healing of hard tissue of extracted tooth socket, Bucco-lingual width, Mesiodistal, height and buccal wall thickness of extracted tooth socket, Histo-pathology evaluation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200324046848N1
Registration date: 2020-12-03, 1399/09/13
Registration timing: retrospective

Last update: 2020-12-03, 1399/09/13
Update count: 0
Registration date
2020-12-03, 1399/09/13
Registrant information
Name
seyyedeh nasrin fa'al rastegar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3730 1370
Email address
nasrinrastegar26@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-23, 1397/10/02
Expected recruitment end date
2020-04-22, 1399/02/03
Actual recruitment start date
2018-12-23, 1397/10/02
Actual recruitment end date
2020-04-22, 1399/02/03
Trial completion date
2020-06-29, 1399/04/09
Scientific title
Investigating the effect of simvastatin and collogen on the healing condition of extracted tooth socket (histomorphometric evaluation).
Public title
The effect of simvastatin on healing of extracted tooth socket
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient with not restorable tooth or crown, a root fracture, extensive decay Residual roots without apical lesions Atraumatic tooth extraction People who are in complete health status
Exclusion criteria:
Smokers Pregnant and lactating women History of radiation therapy and chemotherapy Sensitivity to statin drugs
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Investigator
Sample size
Target sample size: 40
Actual sample size reached: 35
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with randomization table. Randomization is done using Random allocation software (RAS)version 2 by writing the number of groups and the sample size in the specified field and clicking on the generate random list option gives each sample a code in which The group is placed. Allocation concealment as Sequentially numbered, opaque, sealed envelopes (SNOSE); is.The sealed envelopes are given to the ward secretary and she registers the patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher who had measured and recorded the indices were not aware of the intervention which was performed for patients to conduct single blinding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Fajr Ave.,Emam Reza Square., Dentistry Faculty of Shahid Sadoughi University of Medical Sciences and Health Services Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.SSU.REC.1397.120

Health conditions studied

1

Description of health condition studied
Loss of teeth due to extractio
ICD-10 code
K08.1
ICD-10 code description
Complete loss of teeth

Primary outcomes

1

Description
The healing of hard tissue of extracted tooth socket
Timepoint
At baseline and 8 weeks after surgery
Method of measurement
Amount of bone trabecule formed in the extracted tooth socket is measured in histologic specimen using ImageJ software

Secondary outcomes

1

Description
Percentage of mineralized bone
Timepoint
2 months after the surgery
Method of measurement
By histo-pathology evaluation

Intervention groups

1

Description
Intervention group: Simvastatin 10 mg and native collagen (Bone Protect Cone,Dentegris GmbH,Germany) in extracted tooth socket
Category
Treatment - Drugs

2

Description
Control group: Receive native collagen cone (BoneProtect Cone,Dentegris GmbH,Germany) in extracted tooth socket
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Sciences and Health Services Yazd
Full name of responsible person
Nasrin Faal Rastegar
Street address
Fajr Ave., Emam Reza Square., Dentistry Faculty of Shahid Sadoughi University of Medical Sciences and Health Services Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
nasrinrasegar26@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahdie Khezri
Street address
Fajr Ave., Emam Reza Square., Dentistry Faculty of Shahid Sadoughi University of Medical Sciences and Health Services Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
pajoheshdentyazd@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
Farzane Vaziri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Fajr Ave., Emam Reza Square., Dentistry Faculty of Shahid Sadoughi University of Medical Sciences and Health Services Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 913 156 3245
Email
farzane.vaziri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farzane Vaziri
Position
Assisstant professir
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Fajr Ave., Emam Reza Square., dentistry faculty of Shahid Sadoughi University of Medical Sciences and Health Services
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
36255881 (035)
Email
farzane.vaziri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nasrin Faal Rastegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Fajr Ave., Emam Reza Square., Dentistry faculty of Shahid Sadoughi University of Medical Sciences and Health Services
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
36255881 (035)
Email
nasrinrastegar26@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 of evaluated index will be released.
When the data will become available and for how long
6 months after the publication of final result
To whom data/document is available
Anyone can access the dat
Under which criteria data/document could be used
In order to conduct similar research , the date will be accessible
From where data/document is obtainable
nasrinrastegar26@gmail.com
What processes are involved for a request to access data/document
After sending an email and explaining the similar research they are performing, the data will be accessible in 4 weeks
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