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The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.
This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SA Implants | Active Comparator | Dental implant with sandblasted and Acid-etched (SA) surface |
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| SOI Implants | Experimental | Same dental implant with sandblasted and Acid-etched surface modified with pH buffering agent |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of dental implants (surgical procedure) | Procedure | The two study implants have to be placed in the same surgical session according to similar procedures. Implants will be placed in the planned anatomic sites by using a flapless or a miniflap approach. Implants sites will be prepared based on the bone density, and according to the manufacturers's instruction by using the 122 Taper kit (Osstem Implant). |
| Measure | Description | Time Frame |
|---|---|---|
| Implant failure | Implant removal for any reason will be considered an implant failure. | From implant placement up to 60 months after loading |
| Crown failure | Crown replacement for any reason will be considered a crown failure. | From crown delivery up to 60 months |
| Complications | Any complications will be recorded. Examples of biological complications are: nerve injury, fistula, peri-implantitis. Examples of biomechanical complications are fracture of the abutments screw, loosening of the crown, fracture of the ceramic. | From implant placement up to 60 months after loading |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-implant marginal bone level (MBL) changes | It will be assessed on periapical radiographs taken with the paralleling technique. The distance between marginal bone level and implant/abutment junction, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at group level. Non-digital radiographs will be scanned, digitized, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the implant neck. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Tallarico | Contact | +3280758769 | me@studiomarcotallarico.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erta Xhanari | Recruiting | Tirana | Albania |
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| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Randomized controlled trial, split-mouth design
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Implants have same macro design.
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| From implant placement up to 60 months after loading |
| Probing pocket depth (PPD) | Probing pocket depth will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant. | From crown delivery up to 60 months |
| Bleeding on probing (BOP) | Bleeding on probing will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant. | From crown delivery up to 60 months |
| plaque index (PI) | Plaque index will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA) at delivery of the definitive crowns, 1, 3, and 5 years follow-up in function. Three vestibular and three lingual values will be collected for each implant. | From implant placement up to 60 months after loading |
| Implant stability quotient | The implant stability quotient will be recorded by the blind outcome assessor using resonance frequency analysis (Osstell Mentor; Osstell, Goteborg, Sweden).7 Buccopalatal and mesiodistal measurements will be taken and averaged, with the result being displayed by the device in ISQ units, ranging from 1 to 100. | The ISQ values will be recorded at the time of implant placement (baseline) and then 1,2,3,4,5,6,7,8, and 12 weeks after implant placement. |
| Pink Esthetic Score | The aesthetic evaluation will be performed according to the pink aesthetic score on the vestibular and occlusal pictures taken including at least one adjacent tooth per side.8 The values will be assessed at definitive prosthesis delivery, and then early up to the end of the follow-up. Seven variables (mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture) will be assessed with a 2-1-0 score (2 being best and 0 being poorest) by the same blinded dentist. | From crown delivery up to 60 months |
| Elitsa Deliverska | Recruiting | Sofia | Bulgaria |
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| Fulvio Gatti | Recruiting | Milan | Italy |
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| Studio Odontoiatrico Marco Tallarico | Recruiting | Rome | 00151 | Italy |
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| Leonardo Muzzi | Recruiting | Siena | Italy |
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| Łukasz Zadrożny | Recruiting | Warsaw | Poland |
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| Cesaltino Remedios | Recruiting | Fátima | Portugal |
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| Mircea | Recruiting | Craiova | Romania |
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| Andre de Waal | Recruiting | South Africa | South Africa |
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| Nicolas Widmer | Recruiting | Bern | Switzerland |
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