Evaluation of the local effect of clindamycin before the placement of immediate implants(fresh socket) in bone and implant osteointegration after treatment
Determination if the local effect of clindamycin before the placement of immediate implants in bone and implant osteointegration after treatment
Design
A two-arm parallel group with a control group that both study and control groups are from one patient
Settings and conduct
This study use the patient that refer to the postgraduate periodontics unit of dental school at the Islamic Azad university of isfahan
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Minimum age should be 18; the Patient has at least 2 areas that is an infected teeth that should be extracted and implanted.
Exclusion criteria:
Patient has systemic disease; Pregnancy; Patient has peridontitis; Smokers.
Intervention groups
One group use clindamycin
Another one don't use this drug
Main outcome variables
Osteointegration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230607058412N1
Registration date:2023-08-21, 1402/05/30
Registration timing:prospective
Last update:2023-08-21, 1402/05/30
Update count:0
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
Mostafa Esmaeilzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3422 0424
Email address
mostafa.esm22@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-09-01, 1402/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the local effect of clindamycin before the placement of immediate implants(fresh socket) in bone and implant osteointegration after treatment
Public title
Evaluation of the local effect of clindamycin before the placement of immediate implants(fresh socket) in bone and implant osteointegration after treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least one infected tooth that should be extracted
Be indicated for implant insertion
Exclusion criteria:
Smoker's
Low oral hygiene
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Azad university of isfahan
Street address
Arghavanie Ave., danehsgah Blvd., Azad university of isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2023-06-25, 1402/04/04
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.155
Health conditions studied
1
Description of health condition studied
Periimplantitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Rate of osteointegration
Timepoint
3 months
Method of measurement
Periotest device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group solution of clindamycin irrigated at the socket of extracted tooth
Category
Treatment - Drugs
2
Description
Control group: in this group we don't use irigation of clindamycin solution
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Azad university
Full name of responsible person
Ehsan Rafiei
Street address
Arghavanieh
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2000
Email
Info@khuisf.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrdad Barekatain
Street address
Arghavanieh
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2000
Email
Info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Ehsan Rafiei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Arghavanieh
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2000
Email
Info@khuisf.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ehsan Rafiei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Arghavanieh
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2000
Email
Info@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ehsan Rafiei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Arghavanieh
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2000
Email
Info@khuisf.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Final Result of study
When the data will become available and for how long
After the finishing of study at 2023
To whom data/document is available
Patient that included in study
Under which criteria data/document could be used
Improvement of knowledge
From where data/document is obtainable
Azad university
What processes are involved for a request to access data/document