Evaluation of the Effect of the Gap Between Bone and Implant Surface on the Implants Stability

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the changes in the stability of implants of the same macro-design placed with particle grafting in the fresh extraction socket, without grafting and placed in healed implant sites.

Official Title
-----------------
Evaluation of the Effect of the Gap Between Bone and Implant Surface on the Implants Stability

Conditions
-----------------
Missing Teeth

Intervention / Treatment
-----------------
* Device: Dental implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having a non-repairable premolar or molar tooth, or an edentulous area where the corresponding teeth have been extracted at least six months ago, At least 18 years old, Maintaining good dental hygiene, Having a favorable occlusion, Having intact socket walls after extraction. Exclusion Criteria: Any local or systemic disorders that had contraindications for dental implant insertion, Pregnant and lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: With graft<br> | Device: Dental implant<br>* Dental implant placement<br>|
| Active Comparator: Without graft<br> | Device: Dental implant<br>* Dental implant placement<br>|
| Active Comparator: Delayed healing site<br> | Device: Dental implant<br>* Dental implant placement<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Implant Stability Quotient (ISQ) values | Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows: T0: baseline T1: follow-up of one week T2: follow-up of eight weeks T3: follow-up of twelve weeks | 12 weeks | 
| Change in implant stability measured by Easy Check device | Easy check is an implant stability measuring device which gives similar outcome measurements with Ostell and has the advantage of application at any angle with disposable vinyl caps. It gives numerical values from 1 to 100 (higher values mean higher stability). | 12 weeks | 
| Primary insertion torque value | The torque value was recorded as insertion torque value of this case at the moment when the implant positioned at the 1mm under the socket wall edge and correct hex position. It gives numerical values from 0 to 100 (higher values mean higher stability). | 1 day At the implant placement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental implant, primary stability, immediate placement