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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Original CAD/CAM abutment | Active Comparator | Patients will be rehabilitated using Sweden&Martina implants and original (Sweden&Martina) CAD/CAM abutments. |
|
| Compatible CAD/CAM abutment | Experimental | Patients will be rehabilitated using Sweden&Martina implants and compatible (New Ancorvis) CAD/CAM abutments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Original CAD/CAM prosthetic abutment | Device | Original (Sweden&Martina) CAD/CAM abutments will be screwed to the implants at 32N/cm. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David PeƱarrocha Oltra | Contact | 0034649952560 | david.penarrocha@uv.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClĆnica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis | Recruiting | Valencia | 46010 | Spain |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| D000082 | Acetaminophen |
| D009067 | Mouthwashes |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000083 | Acetanilides |
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The devices will have the same shape and will be delivered to the surgeon unlabeled in an identical sterile envelope.
| Compatible CAD/CAM abutment | Device | Compatible (New Ancorvis) CAD/CAM abutments will be screwed to the implants at 32N/cm. |
|
| Local anesthesia | Procedure | Infiltration of 4% articaine with 1:100,000 adrenalin (Inibsa). |
|
| Painkillers | Drug | Patients will be prescribed ibuprofen 600 mg three times per day for five days |
|
| Mouthwashes | Drug | Patients will be prescribed mouth-rinse with chlorhexidine 0.12% twice daily starting 3 days prior to surgery and for 2 weeks afterward |
|
| Implant placement | Device | Dental implants (Sweden & Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions. |
|
| 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 |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |