Comparison of Immediate and Delayed Implantation on Insertion Torque and Primary Stability
Design
Clinical trial, with control group, double blinded, split mouth, on 8 patients
Settings and conduct
The clinical trial study would be done in Islamic azad university dental branch in 2019-2020. Implants with SLA surface in immediate method (case group) and delayed method (control group) will be inserted while they are similar in length, diameter and their position in jaw.
Participants/Inclusion and exclusion criteria
Implants with SLA surface in same length diameter and place in jaw will be inserted in delayed(control) or immediate (case) approach. These patient will be removed:heavy smokers, uncontrolled diabete, poor oral hygiene, pregnant, need ridge augmentation, long term use of NASIDs, oral or intravenous bisphosphonat usage, untreatment periodontal disease
Intervention groups
Recently extracted area will received immediate implant and will be a case group and area in same or opposite sextant will receive delayed implant and will be control group.
Main outcome variables
Primary stability and insertion torque of immediate implantation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048522N1
Registration date:2020-09-01, 1399/06/11
Registration timing:registered_while_recruiting
Last update:2020-09-01, 1399/06/11
Update count:0
Registration date
2020-09-01, 1399/06/11
Registrant information
Name
Ali Hassani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2277 6996
Email address
editor@traumamon.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-02, 1398/07/10
Expected recruitment end date
2020-10-11, 1399/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Immediate and Delayed Implantation on Insertion Torque and Primary Stability
Public title
Comparison of immediate and delayed implantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy systemic conditions
Have at least one hopeless tooth to extract
An edentulous area with similar position in jaw and bone density to area with hopeless tooth
Exclusion criteria:
Heavy smoker
Uncontrolled diabetes
Ridge augmentation necessity
Long term use of NASIDs
Lake of space from opposite jaw that cannot use implant
Oral or intravenous use of Bisphosphonate
Untreatment periodental disease
Malocclusion
Severe cavities
Periapical lesions
Unacceptable occlusion because of over eruption or tilt of teeth to edentulous area
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
8
More than 1 sample in each individual
Number of samples in each individual:
2
Control area will be implanted in delayed approach and case area will be implanted in immediate approach that have hopeless teeth ti extract
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran national committe for ethics in biomedical research
Measure of primary stability of immediate implantation
Timepoint
Immediatly after insertion of implant
Method of measurement
Using Osstell and numbered torque wrench
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The site to receive the implant immediately. After the atroumatic extraction of the tooth and then the full thickness flaps will be prepared under local anesthesia and the osteotomy areas will be prepared according to the manufacturer's instructions. Exploratory examination of the socket after extraction will be performed by the probe to identify defects - especially in the buccal wall - which in this study are considered immediate contraindications. According to the existing protocol for one-step surgery, two implants will be placed in each patient by a calibrated torque wrench for implant placement and torque measurement. The amount of torque for each implant is measured relative to time and the maximum final value will be calculated in Ncm. Immediately after implant placement, an RF analyzer will be used to directly measure initial stability. The resulting data will be displayed as a graph with RF-domain axes. The RF values calculated from the amplitude peak will be displayed as a quantitative scale from zero to 2 called the Implant stability quotient (ISQ). Thus, the higher the ISQ, the higher the stability of the implant. After surgery, the ISQ value for each implant will be measured by the same surgeon (initial stability). The flaps are returned to their original position by the sling suture. All implant stability measurements are repeated three times for each case and the average of three numbers will be recorded as the final value. If the difference between these three numbers in an implant is more than one unit, or indicates an error device, the measuring device will be disconnected, reconnected and the measurement will be performed again.
Category
Treatment - Surgery
2
Description
Control group: On the edentulous side, full-thickness flaps will then be provided under local anesthesia, and osteotomy areas will be prepared according to the manufacturer's instructions. A scale will be placed for implant placement and torque measurement. The amount of torque for each implant is measured relative to time and the maximum final value will be calculated in Ncm. Immediately after implant placement, an RF analyzer will be used to directly measure initial stability. The resulting data will be displayed as a graph with RF-domain axes. The RF values calculated from the amplitude peak will be displayed as a quantitative scale from zero to 2 called the Implant stability quotient (ISQ). Thus, the higher the ISQ, the higher the stability of the implant. After surgery, the ISQ value for each implant will be measured by the same surgeon (initial stability). The flaps are returned to their original position by the sling suture. All implant stability measurements are repeated three times for each case and the average of three numbers will be recorded as the final value. If the difference between these three numbers in an implant is more than one unit, or indicates an error device, the measuring device will be disconnected, reconnected and the measurement will be performed again.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Implant Research Center of Islamic Azad University of Dentistry, Tehran