Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone.

Study Overview
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Brief Summary
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Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.

Detailed Description
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Main goals. Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone. Specific goals. Evaluate the marginal peri-implant bone loss after the healing period through radiographs, from the day of surgery, to a month, to 3 and 6 months after and a year after the implants insertion. Evaluate the primary stability of each individual implant the day of their insertion to verify their load on the moment of surgery and also compare the values of each preparation techniques of implant bone preparation. Evaluate the secondary stability of each individual implant and compare the values of each preparation techniques. Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.

Official Title
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Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone: Randomized Clinical Trials.

Conditions
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Dental Implants, Tooth Loss

Intervention / Treatment
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* Procedure: Piezoelectric osteotomy.
* Procedure: Conventional drilling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Absence of teeth on the aesthetic zone, whether its an incisor, canine or premolar. 3 months after the dental extraction without alveolar scar tissue remains. Bone availability of at least 5mm of width and 13mm of length. At least 2 to 3 mm of soft tissue for the establishment of an adequate peri-implant biological width. Oclusal pattern that ensures prosthetic success. Implants need to have at least a 35 N and 70 ISQ index to be loaded. Index of plaque < 20% and/or inactive periodontal disease. Exclusion Criteria: Acute myocardial infarction in the last 2 months. Uncontrolled coagulation disorders Uncontrolled diabetes (HbA1c> 7.5%). Radiotherapy on head/neck in the last 24 months. Immunocompromised patient. History of medication related to osteonecrosis of the jaws. Psychiatric disorders, alcohol, drugs and large smokers (>10 cigarrillos). Plaque index > 20%. Need for simultaneous or previous peri-implant guided bone regeneration procedures.

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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trials.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piezoelectric osteotomy<br>Implant placement by piezoelectric osteotomy | Procedure: Piezoelectric osteotomy.<br>* Implants placed using the ultrasonic technique.<br>|
| Active Comparator: Conventional drilling<br>Implant placement by conventional drilling | Procedure: Conventional drilling<br>* Implants placed using drilling technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal Bone Loss | To compare MBL measured using radiographs. | 1 month | 
| Marginal Bone Loss | To compare MBL measured using radiographs. | 3 months | 
| Marginal Bone Loss | To compare MBL measured using radiographs. | 6 months | 
| Marginal Bone Loss | To compare MBL measured using radiographs. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary stability | Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording immediately. | Baseline | 
| Secondary stability | Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording at 3 months. | 3 months | 
| Probing depth | Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing. | 3,6,12 months | 
| Bleeding of probing | Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing. | 3,6,12 months | 
| Survival rate | To measure implant success rate. | 3,6,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implants, Piezoelectric osteotomy, Piezoelectric surgery, Immediate load