A Randomised Clinical Trial Investigating Effect of Implant Surface Characteristic on Crestal Marginal Bone Loss, Inflammatory Response and Aesthetic Outcomes: Novel Gradient Anodized and Sandblasted Large-grit Acid-etched Implant Surfaces
Overview
- Phase
- Not Applicable
- Intervention
- Implant Type
- Conditions
- Dental Implant
- Sponsor
- Barts & The London NHS Trust
- Enrollment
- 39
- Locations
- 2
- Primary Endpoint
- Coronal Facial Bone Maintenance
- Status
- Recruiting
- Last Updated
- 10 days ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: over 18 years old,
- •Gender: male and female.
- •Patient must be able and willing to follow study procedures and instructions and have capacity to provide informed consent.
- •Patient must require tooth extraction of a maxillary first premolar or single-rooted anterior tooth as the result of caries, endodontic failure or trauma
- •The extraction site must have adjacent teeth present.
- •Adjacent teeth with no evidence of interdental bone loss
Exclusion Criteria
- •Systemic disease that can interfere with dental implant therapy (e.g. uncontrolled diabetes)
- •2 adjacent teeth requiring extraction
- •Greater than one wall of the socket missing - assessed at time of extraction
- •Any contraindications for oral surgical procedures
- •Any known systemic disease affecting bone metabolism (e.g. Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis, diabetes type I and uncontrolled diabetes type II), systemic infections or recent surgical procedures within 30 days of study initiation;
- •Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) or bone metabolism (e.g. bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit;
- •HIV or viral hepatitis;
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
- •History of local irradiation therapy in the head-neck region
- •Mucosal diseases (e.g. erosive lichen planus)
Arms & Interventions
NGA Implant
NGA Implant (NobelActive TiUltraNP, Nobel Biocare AG, Switzerland)
Intervention: Implant Type
BLX implant (BLX) modSLA Surface
BLX implant (BLX) modSLA Surface (BLX, SLActive, Roxolid, Institut Straumann AG, Switzerland)
Intervention: Implant Type
TLX implant (TLX) modSLA Surface
TLX implant (TLX) modSLA Surface (TLX, SLActive, Roxolid, Institut Straumann AG, Switzerland).
Intervention: Implant Type
Outcomes
Primary Outcomes
Coronal Facial Bone Maintenance
Time Frame: 1 Year post loading
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).
Secondary Outcomes
- Aesthetic Outcome(1 Year post loading)
- Immunological Response(Pre-surgery to 12 Weeks post surgery)
- Primary Stability(1 Year post loading)
- Patient Satisfaction(1 Year post loading)
- Patient Satisfaction- Aesthetics(1 Year post loading)