This prospective study aims to evaluate 5-year clinical, radiographic, and patient-reported outcomes of implant-supported crowns and bridges placed on Neoss implants (ProActive Straight and Tapered) in the anterior maxilla (region 13 - 23). The study is conducted at Brånemarkkliniken, Public Dental Service, Västra Götalandsregionen, Sweden. While the treatment involves established methods and CE-marked devices, long-term data for this specific indication are limited.
The purpose of this study is to conduct a 5-year follow-up of implant-supported crowns and bridges placed on Neoss implants (ProActive Straight and Tapered) in the anterior maxilla (region 13 - 23). This is a prospective, single-center clinical follow-up study evaluating implant-supported prosthetic restorations in the anterior maxilla. Eligible patients receiving crowns or bridges supported by Neoss implants (ProActive Straight and Tapered) will be followed for 5 years. The treatment is based on established methods and CE-marked devices routinely used in clinical practice. However, long-term data for this specific indication are limited, and prospective follow-up is considered to be of clinical relevance. Clinical, radiographic, digital, and patient-reported outcomes will be assessed at prosthetic delivery (baseline), and at 1-year and 5-year follow-ups. The study aims to evaluate the performance of Neoss implants (ProActive Straight and Tapered) as support for single crowns and bridges after 5 years, with respect to complications, function, aesthetics, and patient satisfaction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Participants will receive implant-supported crowns or bridges supported by Neoss dental implants (ProActive Straight and Tapered) placed in the anterior maxilla. Implant placement and prosthetic rehabilitation will be performed according to standard clinical procedures using a commercially available CE-marked implant system. The implants serve as support for fixed prosthetic restorations, and participants will be followed for 5 years to evaluate clinical, radiographic, and patient-reported outcomes.
Brånemark Clinic, Public Dental Health Care Service, Region of Västra Götaland, Gothenburg, Sweden
Gothenburg, Sweden
Implant Survival
Absence of implant loss during the study period.
Time frame: Baseline, 1 year, and 5 years
Change in marginal bone level around implants
Change in marginal bone level around implants as assessed by radiographic evaluation using standardized, anonymized radiographs. Measurements will be performed by an independent examiner.
Time frame: Baseline, 1 year, and 5 years
Peri-implant Soft Tissue Status and change
Clinical assessment and evaluation of peri-implant soft tissue conditions using intraoral scanning and digital comparison over time.
Time frame: Baseline, 1 year, and 5 years
Individual Tooth-Related Pink Esthetic Score (PES)
Evaluation of the peri-implant soft tissue aesthetics using the Pink Esthetic Score at the individual tooth level based on standardized photographic assessment.
Time frame: Baseline, 1 year, and 5 years
Patient-Reported Outcomes
Patient satisfaction and perceived function/aesthetics assessed using a Visual analogue scale for rating (1-10).
Time frame: Baseline, 1 year, and 5 years
Incidence of Adverse Events
Incidence of adverse events, including but not limited to implant loss, marginal bone loss, infection, swelling, and soft tissue complications.
Time frame: Throughout the 5-year study period
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