Bone Loss, Alveolar, Dental Implant Failure Nos
Conditions
Brief summary
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.
Interventions
DEVICEOriginal CAD/CAM prosthetic abutment
Original (Sweden&Martina) CAD/CAM abutments will be screwed to the implants at 32N/cm.
DEVICECompatible CAD/CAM abutment
Compatible (New Ancorvis) CAD/CAM abutments will be screwed to the implants at 32N/cm.
PROCEDURELocal anesthesia
Infiltration of 4% articaine with 1:100,000 adrenalin (Inibsa).
DRUGPainkillers
Patients will be prescribed ibuprofen 600 mg three times per day for five days
DRUGMouthwashes
Patients will be prescribed mouth-rinse with chlorhexidine 0.12% twice daily starting 3 days prior to surgery and for 2 weeks afterward
DEVICEImplant placement
Dental implants (Sweden & Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The devices will have the same shape and will be delivered to the surgeon unlabeled in an identical sterile envelope.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biological complications | 1 year | Proportion of cases with peri-implant disease. |
| Biomechanical complications | 1 year | Proportion of cases with fracture or loosening of screws |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbial loads | 1 year | Quantitative analysis of microbial species will be studied using Illumina protocol for 6S ribosomal RNA |
| Probing Pocket Depth | 1 year | Measured from the mucosal margin to the bottom of the probable pocket. |
| Modified Plaque Index | 1 year | Presence/absence of plaque at the cervical part of the implant-supported crown scored by running a probe along the implant-supported crown surface. |
| Bleeding on Probing | 1 year | Presence/absence of bleeding after probing. |
Countries
Spain
Contacts
Primary ContactDavid Peñarrocha Oltra
Outcome results
None listed