Comparison of implant stability changes (ISQ or Implant Stability Quotient,) in SLA and Impregnated with Ca solution in patients referred to the implant department of Dentistry Azad University and a private clinic
Design
A randomized clinical trial study to examine if there is a difference in the integration of an implant in two different surfaces of acid etching-sandblasting and calcium-impregnated .Clinical evaluation of implants over time will be done using the ISQ (Implant Stability Quotient,) by the Osstell system.
Settings and conduct
The osteotomy cavity would be performed. And if there is an initial Insertion Torque of above 25N samples, then after the ISQ assessment, the initial stability will be recorded,By closing the Gingival former, the implants will be placed in a single step.
4 weeks and 8 weeks after surgery, Gingival former are reopened and an RFA and ISQ record will be assessed. During this time, implants will be examined for clinical conditions n.
Participants/Inclusion and exclusion criteria
30 patients without at least 2 posterior teeth in the mandible or maxillary.
Entry criteria for the study:
1- At least two implants in the posterior maxilla and mandible in each patient
2. Agree with the terms of the research and consent letter
Output criteria of the study:
1. Failure to reach the initial torque above 25N
2- Bone Dehisense Existence
3. Bone typing D4 (decision by surgeon)
4. The presence of uncontrolled systemic disease
5- Top 10 cigarettes per day
6. History of the use of bisphosphonates
7.Need for bone graft
Intervention groups
The control group of implants with SLA level (Osstem SA surface, TS||| SA South Korea) and impregnated with Ca solution group (osstem CA surface, TS||| CA South Korea)
Main outcome variables
Implant stability (ISQ) in case and control group immediately after surgery, 4 weeks and 8 weeks after surgery
General information
Reason for update
Acronym
SLA, ISQ
IRCT registration information
IRCT registration number:IRCT20180714040460N5
Registration date:2019-07-03, 1398/04/12
Registration timing:prospective
Last update:2019-07-03, 1398/04/12
Update count:0
Registration date
2019-07-03, 1398/04/12
Registrant information
Name
Nima Nadafpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
n_nadaf@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2019-11-01, 1398/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of implant stability changes (ISQ or Implant Stability Quotient) in SLA implants with and without calcium solution
Public title
Comparison of Impact of Implant with Two SLA Levels and Calcium Impregnated on Bone around the Implant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least two implants in the posterior of maxilla and mandible in each patient
Agreement with research conditions and Signature of consent
Exclusion criteria:
Failure to achieve primary torque above 25N
Bone dehiscence existence
Bone D4 Type (Decision by Surgeon)
Over 10 cigarettes a day
History of taking bisphosphonates
not required to bone graft
The presence of an uncontrolled systemic related disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
30 patients without at least 2 posterior teeth in Mandible maxilla were randomly divided into two groups: control and test group
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method
By using a coin flipping, we assign one of two implant sites to the SLA, and the other to a impregnated calcium implant.
Blinding (investigator's opinion)
Double blinded
Blinding description
Only the practitioner and surgeon knows the difference between the site of the two implants and the participant, evaluator, analyst and safety committee, and data monitoring are aware of the type of implants used and are blind to the position of each implant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of central organization of Islamic Azad university
Street address
No.9 , 9th Neyestan Ave., Pasdaran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.041
Health conditions studied
1
Description of health condition studied
Implant stability changes (ISQ or implant stability factor) in SLA implants and impregnated with calcium solution
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
ISQ(Implant Stability Quotient)
Timepoint
Immediately after surgery, 4 weeks and 8 weeks after surgery
Method of measurement
Osstell Device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Implants impregnated with calcium to change superficial properties that increase bone responses and accelerate osteointrigation.
Category
Treatment - Devices
2
Description
Control group: SLA implants without calcium solution
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Implant Department of Islamic Azad University and a private clinic*
Full name of responsible person
Nima nadaf pour
Street address
No.9 , 9th Neyestan Ave., Pasdaran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
n_nadaf@dentaliau.ac.ir
2
Recruitment center
Name of recruitment center
private office of Dr.Nima Naddaf pour
Full name of responsible person
Nima Naddaf pour
Street address
Unit.24 , No.38 , Juy pa alley , Sarv cross , Paknejad blvd , Saadat Aabad Town
City
Tehran
Province
Tehran
Postal code
1998798331
Phone
+98 21 2676 7768
Email
n_nadaf@dentaliau.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nima nadafpour
Street address
No.9 , 9th Neyestan Ave., Pasdaran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
n_nadaf@dentaliau.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
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
Islamic Azad University
Full name of responsible person
Nima Nadafpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit.24 ,No.38 ,Juy pa alley , Sarv cross ,Paknejad blvd ,Saadat Aabad Town
City
Tehran
Province
Tehran
Postal code
1998798331
Phone
+98 21 2676 7768
Fax
Email
n_nadaf@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nima Nadafpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit.24 ,No.38 ,Juy pa alley , Sarv cross ,Paknejad blvd ,Saadat Aabad Town
City
Tehran
Province
Tehran
Postal code
1998798331
Phone
+98 21 2676 7768
Fax
Email
n_nadaf@dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nima Nadafpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit.24 ,No.38 ,Juy pa alley , Sarv cross ,Paknejad blvd ,Saadat Aabad Town
City
Tehran
Province
Tehran
Postal code
1998798331
Phone
+98 21 2676 7768
Fax
Email
n_nadaf@dentaliau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information with respect to the subject