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| ID | Type | Description | Link |
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| IRAS:329055 | Registry Identifier | IRAS |
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| Name | Class |
|---|---|
| Virginia Commonwealth University | OTHER |
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This study aims to characterise the stability of crestal bone levels one year after loading, the associated aesthetic outcomes, immunological response, prosthodontic outcomes as well as overall patient reported outcome measures for modSLA (SLActive, Institut Straumann AG, Switzerland) and NGA (TiUltraNP, Nobel Biocare AG, Switzerland) dental implants.
Ultra-hydrophilic SLActive (modSLA) implants have been extensively studied in pre-clinical and clinical studies, demonstrating their pro-osteogenic nature and long-term maintenance of facial bone and aesthetics.
A novel multi-zone novel gradient anodized (NGA) hydrophilic surface (TiUltra) has recently been introduced to clinical practice. Pre-clinical studies have demonstrated that the smoother coronal aspect achieved stable soft tissue adhesion.
In clinical practice, prosthetically driven implant placement, particularly in the anterior maxilla, may result in a buccal dehiscence that is commonly treated with guided bone regeneration (GBR). Currently no studies have been published investigating differences between these commercially available implant surfaces (modSLA, NGA).
This prospective, single centre randomised clinical trial will recruit 39 patients who require a single tooth extraction in the anterior maxilla for a Type IIc implant placement.
Patients enrolled in the study will be allocated to one of three implant groups:
This study aims to characterise the stability of crestal bone levels one year after loading, the associated aesthetic outcomes, immunological response, prosthodontic outcomes as well as overall patient reported outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGA Implant | Experimental | NGA Implant (NobelActive TiUltraNP, Nobel Biocare AG, Switzerland) |
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| BLX implant (BLX) modSLA Surface | Experimental | BLX implant (BLX) modSLA Surface (BLX, SLActive, Roxolid, Institut Straumann AG, Switzerland) |
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| TLX implant (TLX) modSLA Surface | Experimental | TLX implant (TLX) modSLA Surface (TLX, SLActive, Roxolid, Institut Straumann AG, Switzerland). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant Type | Device | Patients enrolled in the study will be allocated to one of three implant groups:
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| Measure | Description | Time Frame |
|---|---|---|
| Coronal Facial Bone Maintenance | A numerical comparison of coronal facial bone thickness between the groups. CBCT scans will be compared to quantify the linear changes in crestal bone thickness at the coronal aspect of the implant (shoulder of NGA and BLX implants and rough-smooth transition of TLX implant). | 1 Year post loading |
| Measure | Description | Time Frame |
|---|---|---|
| Aesthetic Outcome | - A numerical comparison of the three groups from an objective aesthetic scale derived from a panel of 2 dentists. | 1 Year post loading |
| Patient Satisfaction | - A numerical comparison of the patient satisfaction between the three groups derived from an analysis of patient questionnaires (Likert Scales). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal London Dental Institute | Recruiting | London | E1 1BB | United Kingdom |
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| 1 Year post loading |
| Patient Satisfaction- Aesthetics | - A numerical comparison of the aesthetic merit between the three groups derived from an analysis of patient questionnaires (Likert scales) | 1 Year post loading |
| Primary Stability | A numerical comparison of primary stability measurement of the three groups (IT, RFA). | 1 Year post loading |
| Immunological Response | - A numerical and qualitative comparison of inflammatory profiles derived from peripheral blood of the three groups | Pre-surgery to 12 Weeks post surgery |