Immediate Loading and Fully Guided Surgery: Single Implants

Study Overview
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Brief Summary
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To evaluate the overall treatment outcome of single implants installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning, during a 1-year follow-up period.

Official Title
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Immediate Loading of Single Implants, Guided Surgery, Digital Impression and CAD/CAM Technology: Clinical and Patient-centered Outcome.

Conditions
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Osseointegration Failure of Dental Implant

Intervention / Treatment
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* Procedure: Immediate loading, fully guided surgery and 3D printed restoration
* Procedure: Immediate loading


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years of age who had signed an informed consent in need of a single-tooth replacement of an incisor, canine or pre-molar in the maxilla. Exclusion Criteria: general contraindications for oral surgery patients with inadequate oral hygiene need for bone grafting or ridge augmentation.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Immediate loading<br>Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing | Procedure: Immediate loading, fully guided surgery and 3D printed restoration<br>* Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.<br>|
| Other: Immediate loading<br>Historic cohort subjected to immediate loading | Procedure: Immediate loading<br>* Only subjected to immediate loading. Conventional procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Implant Survival | Survival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction | 12 months | 
| MBL | Marginal bone loss MBL, measured in mm from implant abutment junction. | 12 months | 
| Pink Esthetic Score | Pink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome. | 12 months | 
| White Esthetic Score | White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome. | 12 months | 
| Oral Health Impact Profile - 14 | Oral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite. | 12 months |