Implant/Abutment Module Stability of Original vs Compatible Connections

Study Overview
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Brief Summary
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Together with materials and type of retention, the stability of the implant abutment connection represents one of the key factor for the success rate of an implant supported restoration. The recent diffusion of high quality and easy to use CAD/CAM systems has contributed to market launch of a number of competing companies that offer the so called clonical or compatible restorative components. Although they are claimed to be identical, the original abutments are supposed to present maximum accuracy and consequently lower microleakage. The aim of the present randomized controlled trial will be to analyze the implant abutment junction stability comparing implant-supported crowns restored with original components and compatible non-original abutments. The hypothesis is that original components will present significantly better stability than non-original abutments.

Official Title
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Implant/Abutment Module Stability: a RCT Comparing Original vs Compatible Connections (Estabilidad Del módulo Implante/Pilar: ECA Comparando Conexiones Originales vs Compatibles).

Conditions
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Bone Loss, Alveolar, Dental Implant Failure Nos

Intervention / Treatment
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* Device: Original CAD/CAM prosthetic abutment
* Device: Compatible CAD/CAM abutment
* Procedure: Local anesthesia
* Drug: Painkillers
* Drug: Mouthwashes
* Device: Implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any healthy patient scheduled for an implant-supported restoration will be considered for inclusion in this study, independently of the implant and prosthetic protocols used. Exclusion Criteria: general medical contraindications to oral surgery (American Society of Anesthesiologist, ASA, class III or IV), patients <18 years of age, smoking habit (>10 cigarettes/day), sites with acute infection or requiring regenerative procedures, Full Mouth Plaque Score Full Mouth Bleeding Score >25 %, pregnant and lactating.

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Original CAD/CAM abutment<br>Patients will be rehabilitated using Sweden&Martina implants and original (Sweden&Martina) CAD/CAM abutments. | Device: Original CAD/CAM prosthetic abutment<br>* Original (Sweden&Martina) CAD/CAM abutments will be screwed to the implants at 32N/cm.<br>Procedure: Local anesthesia<br>* Infiltration of 4% articaine with 1:100,000 adrenalin (Inibsa).<br>Drug: Painkillers<br>* Patients will be prescribed ibuprofen 600 mg three times per day for five days<br>Drug: Mouthwashes<br>* Patients will be prescribed mouth-rinse with chlorhexidine 0.12% twice daily starting 3 days prior to surgery and for 2 weeks afterward<br>Device: Implant placement<br>* Dental implants (Sweden & Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions.<br>|
| Experimental: Compatible CAD/CAM abutment<br>Patients will be rehabilitated using Sweden&Martina implants and compatible (New Ancorvis) CAD/CAM abutments. | Device: Compatible CAD/CAM abutment<br>* Compatible (New Ancorvis) CAD/CAM abutments will be screwed to the implants at 32N/cm.<br>Procedure: Local anesthesia<br>* Infiltration of 4% articaine with 1:100,000 adrenalin (Inibsa).<br>Drug: Painkillers<br>* Patients will be prescribed ibuprofen 600 mg three times per day for five days<br>Drug: Mouthwashes<br>* Patients will be prescribed mouth-rinse with chlorhexidine 0.12% twice daily starting 3 days prior to surgery and for 2 weeks afterward<br>Device: Implant placement<br>* Dental implants (Sweden & Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological complications | Proportion of cases with peri-implant disease. | 1 year | 
| Biomechanical complications | Proportion of cases with fracture or loosening of screws | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial loads | Quantitative analysis of microbial species will be studied using Illumina protocol for 6S ribosomal RNA | 1 year | 
| Probing Pocket Depth | Measured from the mucosal margin to the bottom of the probable pocket. | 1 year | 
| Modified Plaque Index | Presence/absence of plaque at the cervical part of the implant-supported crown scored by running a probe along the implant-supported crown surface. | 1 year | 
| Bleeding on Probing | Presence/absence of bleeding after probing. | 1 year |