The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics

Study Overview
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Brief Summary
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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.

Official Title
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The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics: Multicentric RCT

Conditions
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Peri-Implantation Loss, Periodontal Bone Loss, Periimplantitis, Gingival Inflammation, Implant Complication, Osseointegration Failure of Dental Implant

Intervention / Treatment
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* Device: implants placement


Participation Criteria
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Eligibility Criteria
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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.

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: machined collar<br>The arm will be constituted by healthy people, that need to be rehabilitated by dental implant placement. A short implant (length 6mm; diameter 4.3) will be inserted in an edentulous site. The implant will present a surface treated with double acid etching and traditional machined collar. A definitive transgingival standard machined abutment will be immediately screwed. Four months later, prosthetic procedures will start. | Device: implants placement<br>* 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.<br>|
| Experimental: anodized collar<br>The arm will be constituted by healthy people, that need to be rehabilitated by dental implant placement. A short implant (length 6mm; diameter 4.3) will be inserted in an edentulous site. The implant will present a surface treated with double acid etching and anodized collar. A definitive transgingival anodized abutment will be immediately screwed. Four months later, prosthetic procedures will start. | Device: implants placement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal Bone remodeling around the implant | 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. | 0-4-12 months after implant placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal indexes: Probing Depth | 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. | The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement. | 
| Implant Stability evaluation | 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. | 0-4 months. | 
| Bleeding on Probing | 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 (%) | The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement. | 
| Suppuration on probing | 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 (%) | The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement. | 
| Plaque index of peri-implant tissues | Plaque Index (PI) will be calculated by assigning a binary score to each surface (1= plaque present, 0 = plaque absent). | The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short implants, surface treatment