Clinical Efficacy of the Immediate Implant Loading

Study Overview
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Brief Summary
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Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect). Materials and methods: 20 implant in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is achieved for the 20 implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing and bone resorption Esthetic assessment and patient acceptance will be assessed using specific tools. Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.

Detailed Description
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Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect). Materials and methods: 20 implant (Implant Direct ) in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is achieved for the 20 implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing and bone resorption Aesthetic assessment and patient acceptance will be assessed using specific tools Lab aspect: surface roughness and Marginal fit will be measured to have clue vision. The participants were non-dental students from University colleges in and around Damascus. They were recruited by reviewing the case documents 20 patient with hapless incisal and canine for extraction and immediate implantation and immediate loading with either the two different provisional methods participants had to demonstrate a hopeless central incisor or canine with no perio-active infection. With two types of provisional technique we will have a two groups were calculated a priori in such a way that index can be identified with with alpha = .05 in a two-tailed test, a sample size of 2 X10 implants would result in a power of 94% (g power 3.1.3) based on a pilot study. Cone-beam computed tomography (CBCT) images for each patient to measure the bone level change and aesthetic assessment by three general dentists will be achieved. Replica technique required the application of impression material build up of addition-silicone. Addition-silicone of very low viscosity (ExpressTM2 Ultra-Light Body Quick) was applied to all restorations interior, after which the crowns were set onto basic samples. Impression material was polymerized within the time which is recommended by the manufacturer, while the pressure force of 50 N was applied toward occlusal direction After the removal of all restorations from the basic samples, the layer of impression material remained on the restoration's inner surface due to its higher roughness compared to the abutment surface. With Rt 200 device the roughness will bw measured and then Scanning Electronic Microscope (SEM) images will give a close understanding of the surface. Easy shade will measure the color change.

Official Title
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Evaluation of the Clinical Efficacy of the Immediate Implant Loading in the Aesthetic Zone

Conditions
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Implant Site Reaction

Intervention / Treatment
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* Procedure: Direct provisional technique
* Procedure: Indirect Provisional technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: esthetic request. either incisor or canine indicated for extraction. symmetrical gingival level. no active periodontal disease. age between 20-40 years old Exclusion Criteria: Lateral hopeless tooth . Active periodontal lesion . loss of periodontal tissue . missed incisor or missed canine in the area of implantation.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct provisional technique<br>Patients here will be subjected to the direct provisional technique | Procedure: Direct provisional technique<br>* The method of implantation will be accomplished directly.<br>|
| Active Comparator: Indirect Provisional technique<br>Patients here will be subjected to the indirect provisional technique | Procedure: Indirect Provisional technique<br>* The method of implantation will be accomplished indirectly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in alveolar bone level | This will be measured using cone-beam computed tomography images | T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation | 
| Change in the Gingival Index | This will be measured using the the gingival index | T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation | 
| Change in Esthetic Appearance | This will be measured by using the White Esthetic Scale (WES) | T1: at one day before implantation, T2: at three months following implantation | 
| Change in the Plaque Index | This will be measured using the the plaque index | T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation | 
| Change in the Pink Esthetic Scale | This will be measured using the Pink Esthetic Scale | T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Restoration Color | This will be measured using a standardized color guide | T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation |