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: * Group 1: NGA Implant (NobelActive TiUltraNP, Nobel Biocare AG, Switzerland) * Group 2: BLX implant (BLX) modSLA Surface (BLX, SLActive, Roxolid, Institut Straumann AG, Switzerland) * Group 3: TLX implant (TLX) modSLA Surface (TLX, SLActive, Roxolid, Institut Straumann AG, Switzerland). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
Patients enrolled in the study will be allocated to one of three implant groups: * Group 1: NGA Implant (NobelActive TiUltraNP, Nobel Biocare AG, Switzerland) * Group 2: BLX implant (BLX) modSLA Surface (BLX, SLActive, Roxolid, Institut Straumann AG, Switzerland) * Group 3: TLX implant (TLX) modSLA Surface (TLX, SLActive, Roxolid, Institut Straumann AG, Switzerland).
Royal London Dental Institute
London, United Kingdom
RECRUITINGCoronal 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).
Time frame: 1 Year post loading
Aesthetic Outcome
\- A numerical comparison of the three groups from an objective aesthetic scale derived from a panel of 2 dentists.
Time frame: 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).
Time frame: 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)
Time frame: 1 Year post loading
Primary Stability
A numerical comparison of primary stability measurement of the three groups (IT, RFA).
Time frame: 1 Year post loading
Immunological Response
\- A numerical and qualitative comparison of inflammatory profiles derived from peripheral blood of the three groups
Time frame: Pre-surgery to 12 Weeks post surgery
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