This study aimed to assess the effect of Atorvastatin gel on clinical and histological parameters in dental socket preservation
Design
Randomized clinical trial with control group, parallel group and double blind, on 15 patients
Settings and conduct
The present clinical trial is performed on 15 patients who need to extract at least two teeth. In each patient, Atorvastatin gel with collagen membranes are used to maintain the alveolar socket on one side and collagen membranes on the other side. The patient is not aware of the type of treatment.
Participants/Inclusion and exclusion criteria
Patients who required extraction of two teeth
Intervention groups
Atorvastatin gel with resorbable collagen membrane in intervention group and resorbable collagen membrane in control group
Main outcome variables
Width and height of dental socket; width and thickness of gingiva before and 2 months after intervention; histology index of ossification percentage and thickness of trabeculae, 2 months after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110109005570N11
Registration date:2021-07-22, 1400/04/31
Registration timing:prospective
Last update:2021-07-22, 1400/04/31
Update count:0
Registration date
2021-07-22, 1400/04/31
Registrant information
Name
Parichehr Behfarnia
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1666 1707
Email address
behfarnia@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effects of using 1.2% Atorvastatin gel with absorbable membrane on clinical and histological parameters in socket preservation
Public title
Effect of Atorvastatin gel on clinical and histological parameters in socket preservation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with healthy systemic condition
Single-rooted or double-rooted teeth
Presence of sound buccal and lingual plates after tooth extraction
Presence of a minimum of 10 mm vertical bone height without invading the adjacent critical structures,
Exclusion criteria:
Allergy to collagen membrane
Severe untreated periodontitis
Acute infection or pus at the extraction site
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
15 patients who required extraction of two teeth
Randomization (investigator's opinion)
Randomized
Randomization description
In each patient, one dental socket is selected as the case and the other socket as the control. Randomization method for selecting the socket in each patient is done by the sealed envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant is not able to identify the type of treatment performed. The person performing the histological examination is not aware of the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib- Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
814673461
Approval date
2020-05-31, 1399/03/11
Ethics committee reference number
IR.MUI.MED.REC.1398.107
Health conditions studied
1
Description of health condition studied
socket preservation
ICD-10 code
K08.40
ICD-10 code description
Partial loss of teeth, unspecified cause
Primary outcomes
1
Description
Length of socket
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Periodontal probe
2
Description
Width of socket
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Periodontal probe
3
Description
Width of keratinized gingiva
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Periodontal probe
4
Description
Thickness of gingiva
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Periodontal probe
5
Description
Percent of ossification of alveolar socket
Timepoint
2 months after the intervention
Method of measurement
Histological evaluation
6
Description
Thickness of new trabecula
Timepoint
2 months after the intervention
Method of measurement
Histological evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: extraction of tooth and placing atorvastatin gel in socket and covering it with claprotect membranes made by Bottis company and then suturing on it
Category
Treatment - Other
2
Description
Control group: extraction of tooth and covering socket by claprotect membranes made by Bottis company and then suturing on it
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school, Medical University of Isfahan
Full name of responsible person
Parichehr Behfarnia
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673761
Phone
+98 31 3792 5570
Email
dr.pbehfarnia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nakisa Torabinia
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673761
Phone
+98 31 3792 5524
Email
torabinia@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673761
Phone
+98 31 3792 5559
Email
behfarnia@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
seyedh Negin Hosseini
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Shiraz University of Medical Sciences, Ghasrodasht St,
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
n.hosseini67@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyedeh Negin Hosseini
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Shiraz University of Medical Sciences, Ghasrodasht St,
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
n.hosseini@yahoo.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
All data can be shared after unidentifying individuals
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
for all researcher
Under which criteria data/document could be used
For a comparative study
From where data/document is obtainable
Dr. Negin Hosseini, assistant professor of dental school, Shiraz University of Medical Sciences
What processes are involved for a request to access data/document
Request via email to the corresponded and will be send within 3 months after review