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NCT Number: NCT07544706

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Tooth Loss in the Anterior Maxilla Partial Edentulism of the Maxilla

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Gothenburg, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neoss Implant System (ProActive Straight and Tapered)

Device

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.

Primary outcomes

  1. Implant Survival

    Time frame: Baseline, 1 year, and 5 years

    Absence of implant loss during the study period.

  2. Change in marginal bone level around implants

    Time frame: 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 outcomes

  1. Peri-implant Soft Tissue Status and change

    Time frame: Baseline, 1 year, and 5 years

    Clinical assessment and evaluation of peri-implant soft tissue conditions using intraoral scanning and digital comparison over time.

  2. Individual Tooth-Related Pink Esthetic Score (PES)

    Time frame: 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.

  3. Patient-Reported Outcomes

    Time frame: Baseline, 1 year, and 5 years

    Patient satisfaction and perceived function/aesthetics assessed using a Visual analogue scale for rating (1-10).

  4. Incidence of Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Branemarkkliniken

Other

Collaborators

  • Neoss Ltd., Harrogate, UK

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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