Gingival Inflammation, Implant Complication, Osseointegration Failure of Dental Implant, Peri-Implantation Loss, Periimplantitis, Periodontal Bone Loss
Conditions
Keywords
short implants, surface treatment
Brief summary
The aim of the research is to evaluate the clinical outcome of short dental implants, characterized by a new macro-structural design and inserted in the upper or lower jaw in patients with reduced bone volume. The clinical outcomes will be compared for different surface treatments of implant neck and those of prosthetic components.
Interventions
DEVICEimplants placement
The intervention will consist of placement of two types of short implants (one with traditional machined collar and one with anodized collar). After their healing period, the prosthetic rehabilitation will be made.
Sponsors
Universita degli Studi di Genova
University of Turin, Italy
University of Foggia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* healthy patients, with edentulous maxillary or mandibular ridge, requiring rehabilitation with two adjacent implants; * at least 6 month after extraction;
Exclusion criteria
* post-extractive implants; * sites requiring bone regeneration or maxillary sinus lift; * general health problems that contraindicate implant treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone remodeling around the implant | 0-4-12 months after implant placement | The marginal bone remodeling will be evaluated by Radiographic examination. Periapical radiographs will be performed using paralleling technique with a Rinn-type positioner, customized for each patient at implant placement (T0), prosthetic restoration delivery (T1), and after 12 months (T2).Peri-implant bone levels will be measured at each time point as the linear distance (in mm) between implant platform and bone crest at mesial and distal aspects of each implant. A positive value will be assigned if the bone crest is coronal to the implant platform, whereas a negative value will be assigned if the first bone-to implant contact is apical to the implant platform. All measurements will be performed by two examiners, using measuring software (Image J). Each measurement will be performed three times at three different points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque index of peri-implant tissues | The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement. | Plaque Index (PI) will be calculated by assigning a binary score to each surface (1= plaque present, 0 = plaque absent). |
| Periodontal indexes: Probing Depth | The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement. | Probing Depth (PD) will be calculated as the distance (in mm) from the gingival peri-implant margin to the bottom of the peri-implant pocket. |
| Implant Stability evaluation | 0-4 months. | Primary and secondary implant stability will be measured with resonance frequency analysis (RFA) and subsequently expressed as an implant stability quotient (ISQ). The Implant stability will be measured immediately after placement (T0) and at 4 months (T1) after placement, when the osseointegration is supposed to take place. |
| Bleeding on Probing | The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement. | Bleeding on probing (BoP) will be scored dichotomously (Yes/No). The probing will be performed on 6 sites around the implant (3 buccal and 3 palatal/lingual) and appearance of blood will be registered (Yes). The final score will be expressed as number of bleeding sites/total of probed sites (%) |
| Suppuration on probing | The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement. | Suppuration on probing (SUP) will be scored dichotomously (Yes/No). The probing will be performed on 6 sites around the implant (3 buccal and 3 palatal/lingual) and appearance of pus or purulent exudate will be registered (Yes). The final score will be expressed as number of suppurative sites/total of probed sites (%) |
Countries
Italy
Outcome results
None listed