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

NCT07544706 | Active Not Recruiting

• 1 other identifier: 2020-04621
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Implant Survival

  Absence of implant loss during the study period.

  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.

  Baseline, 1 year, and 5 years

Secondary Outcomes (4)

• Peri-implant Soft Tissue Status and change

  Baseline, 1 year, and 5 years

• Individual Tooth-Related Pink Esthetic Score (PES)

  Baseline, 1 year, and 5 years

• Patient-Reported Outcomes

  Baseline, 1 year, and 5 years

• Incidence of Adverse Events

  Throughout the 5-year study period

Study Arms (1)

Implant-Supported Crowns and Bridges on Neoss Implants (ProActive Straight and Tapered)

EXPERIMENTAL

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)

Interventions

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.

Implant-Supported Crowns and Bridges on Neoss Implants (ProActive Straight and Tapered)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Branemarkkliniken: lead
• Neoss Ltd., Harrogate, UK: collaborator

Study Sites (1)

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

Gothenburg, Sweden

Location

Study Officials

• Victoria F Stenport, DDS, PhD

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

  PRINCIPAL INVESTIGATOR

• Jan Kowar, DDS, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: March 21, 2021
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

SE (1)