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

April 16, 2026 updated by: Branemarkkliniken

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implant-Supported Crowns and Bridges on Neoss Implants (ProActive Straight and Tapered)
Participants will receive implant-supported crowns or bridges supported by Neoss implants (ProActive Straight and Tapered) placed in the anterior maxilla as part of routine clinical treatment. Prosthetic rehabilitation will be performed following standard clinical procedures, and participants will be followed for 5 years to assess clinical, radiographic, and patient-reported outcomes.
Device: Neoss 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survival
Time Frame: Baseline, 1 year, and 5 years
Absence of implant loss during the study period.
Baseline, 1 year, and 5 years
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.
Baseline, 1 year, and 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 year, and 5 years
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.
Baseline, 1 year, and 5 years
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).
Baseline, 1 year, and 5 years
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.
Throughout the 5-year study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Branemarkkliniken

Collaborators

Neoss Ltd., Harrogate, UK

Investigators

  • Principal Investigator: Victoria F Stenport, DDS, PhD, Brånemark Clinic, Public Dental Health Care Service, Region of Västra Götaland, Gothenburg, Sweden
  • Study Chair: Jan Kowar, DDS, PhD, Brånemark Clinic, Public Dental Health Care Service, Region of Västra Götaland, Gothenburg, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2021

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-04621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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