A Follow-Up Study of Straight and Tapered Dental Implants in the Front Upper Jaw

A Prospective Clinical Follow-up Study of Straight and Tapered Dental Implants Placed in the Anterior Maxilla

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07544706

Enrollment

Registered

2026-04-22

Start date

2021-03-21

Completion date

2030-07-31

Last updated

2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Edentulism of the Maxilla, Tooth Loss in the Anterior Maxilla

Keywords

Neoss Dental Implants, Implant-Supported Prosthesis, Anterior Maxilla, Marginal Bone Loss, Aesthetic Outcome

Brief summary

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.

Detailed description

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.

Interventions

DEVICENeoss Implant System (ProActive Straight and Tapered)

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Signed informed consent to participate in the study. Adults ≥18 years of age requiring an implant-supported crown or bridge in the anterior maxilla (region 13-23). No prior bone augmentation required at the implant site. The implant site must be free from signs of infection.

Exclusion criteria

Individuals under 18 years of age. Individuals unable to provide informed consent due to disease, mental disorder, impaired health status, or similar conditions. Presence of systemic or local disease/condition contraindicating implant treatment. Lack of availability for follow-up visits over the 5-year study period. Previous radiotherapy to the head, neck, or jaw region. Untreated or uncontrolled periodontitis and/or peri-implantitis. Use of immunosuppressive medication. Uncontrolled diabetes mellitus. Severe alcohol and/or substance abuse.

Design outcomes

Primary

Measure	Time frame	Description
Implant Survival	Baseline, 1 year, and 5 years	Absence of implant loss during the study period.
Change in marginal bone level around implants	Baseline, 1 year, and 5 years	Change in marginal bone level around implants as assessed by radiographic evaluation using standardized, anonymized radiographs. Measurements will be performed by an independent examiner.

Secondary

Measure	Time frame	Description
Peri-implant Soft Tissue Status and change	Baseline, 1 year, and 5 years	Clinical assessment and evaluation of peri-implant soft tissue conditions using intraoral scanning and digital comparison over time.
Individual Tooth-Related Pink Esthetic Score (PES)	Baseline, 1 year, and 5 years	Evaluation of the peri-implant soft tissue aesthetics using the Pink Esthetic Score at the individual tooth level based on standardized photographic assessment.
Patient-Reported Outcomes	Baseline, 1 year, and 5 years	Patient satisfaction and perceived function/aesthetics assessed using a Visual analogue scale for rating (1-10).
Incidence of Adverse Events	Throughout the 5-year study period	Incidence of adverse events, including but not limited to implant loss, marginal bone loss, infection, swelling, and soft tissue complications.

Countries

Sweden

Contacts

PRINCIPAL_INVESTIGATORVictoria F Stenport, DDS, PhD

Brånemark Clinic, Public Dental Health Care Service, Region of Västra Götaland, Gothenburg, Sweden

STUDY_CHAIRJan Kowar, DDS, PhD