Randomized Controlled Trial of Full-Arch Rehabilitation

Study Overview
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Brief Summary
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This clinical study has the objective to compare the radiographic evaluations after 3 years of follow-up of immediate loaded implant-prosthetic rehabilitation, carried out randomly using the methodology for computer guided implant planning with software polyvalent or free hand implants placement.

Official Title
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Clinical Evaluation of Immediate Loading Full Arch Rehabilitation Made With Methodology for Computer Guided Implant Planning With Software Polyvalent vs Free Hand Implants Placement

Conditions
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Bone-to-implant Contact, Success Rate, Survival Rate

Intervention / Treatment
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* Procedure: computer guided implant planning
* Procedure: free hand implants placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Edentulous patients with an adequate area: at least two teeth in the posterior area Age over 18 years Adequate width of the bone crest without the need for bone regeneration Consensus to participate in a oral hygiene maintenance program Consensus to participate in a long-term study Availability to provide their free and informed consensus. Exclusion Criteria: Systemic diseases that preclude participation in the study History of radiation therapy Bone lesions Cigarette smoking (more than 10 cigarettes per day) Inadequate oral hygiene Untreated periodontitis affecting residual teeth

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: computer guided implant planning<br>radiographic and clinical evaluation of full-arch dental implant rehabilitation | Procedure: computer guided implant planning<br> <br> |
| Experimental: free hand implants placement<br>radiographic and clinical evaluation of full-arch dental implant rehabilitation | Procedure: free hand implants placement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone-to-implant contact | 2D radiographic assessment of the implant surface in contact with bone expressed in percentage | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant survival rate | the absence of clinically detectable implant mobility a lack of persistent or irreversible signs and symptoms such as pain or any subjective sensation the absence of recurrent peri-implant infection the absence of concrete evidence of continuous periimplant radiolucency | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implants, immediate loading, full-arch, computer guided implant surgery