Tooth Loss in the Anterior MaxillaNCT07544706
A Follow-Up Study of Straight and Tapered Dental Implants in the Front Upper Jaw
A study testing Neoss Implant System (ProActive Straight and Tapered) in people with Tooth Loss in the Anterior Maxilla and Partial Edentulism of the Maxilla, run by Branemarkkliniken at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss in the Anterior Maxilla, Partial Edentulism of the Maxilla
- What is being tested?
- Neoss Implant System (ProActive Straight and Tapered)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSweden
- Study dates
- 21 Mar 2021to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Brånemark Clinic, Public Dental Health Care Service, Region of Västra Götaland, Gothenburg, Sweden
Gothenburg
About this study
Official title: 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.
Read the 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.
- Being tested
- Neoss Implant System (ProActive Straight and Tapered)
- Keywords
- Neoss Dental Implants, Implant-Supported Prosthesis, Anterior Maxilla, Marginal Bone Loss, Aesthetic Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Neoss Implant System (ProActive Straight and Tapered) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival
Absence of implant loss during the study period.
Measured: 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.
Measured: Baseline, 1 year, and 5 years
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Throughout the 5-year study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start21 Mar 2021
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Loss in the Anterior MaxillaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Branemarkkliniken
- Sponsor type
- University, hospital or other
- Collaborators
- Neoss Ltd., Harrogate, UK
- Responsible party
- Sponsor
- Investigators
- Victoria F Stenport, DDS, PhD, Principal investigator, Brånemark Clinic, Public Dental Health Care Service, Region of Västra Götaland, Gothenburg, SwedenJan Kowar, DDS, PhD, Study chair, Brånemark Clinic, Public Dental Health Care Service, Region of Västra Götaland, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544706
- Sponsor's protocol ID
- 2020-04621
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Follow-up Study of Straight and Tapered Dental Implants Placed in the Anterior Maxilla
- ClinicalTrials.gov ID
- NCT07544706
- Acronym / sponsor ID
- 2020-04621
- Keywords
- Neoss Dental Implants, Implant-Supported Prosthesis, Anterior Maxilla, Marginal Bone Loss, Aesthetic Outcome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- BranemarkklinikenUniversity, hospital or other
- Collaborators
- Neoss Ltd., Harrogate, UK
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant-Supported Crowns and Bridges on Neoss Implants (ProActive Straight and Tapered) | Experimental | Device: Neoss Implant System (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Implant-Supported Crowns and Bridges on Neoss Implants (ProActive Straight and Tapered) |
Primary outcome
Implant Survival
Time frame: Baseline, 1 year, and 5 years
Absence of implant loss during the study period.
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.
4 secondary outcomes
Peri-implant Soft Tissue Status and change
Time frame: Baseline, 1 year, and 5 years
Individual Tooth-Related Pink Esthetic Score (PES)
Time frame: Baseline, 1 year, and 5 years
Patient-Reported Outcomes
Time frame: Baseline, 1 year, and 5 years
Incidence of Adverse Events
Time frame: Throughout the 5-year study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Tooth Loss in the Anterior Maxilla
Not yet recruiting
Peri-Implant Hard and Soft Tissue Changes After Immediate Implant Placement With Socket Shield and Immediate Restoration Versus Early Implant Placement in the Esthetic Zone
Tooth Loss in the Anterior Maxilla, Alveolar Bone Resorption
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria F Stenport, DDS, PhD principal investigator
Brånemark Clinic, Public Dental Health Care Service, Region of Västra Götaland, Gothenburg, Sweden
Jan Kowar, DDS, PhD study chair
Brånemark Clinic, Public Dental Health Care Service, Region of Västra Götaland, Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoss Implant System (ProActive Straight and Tapered) in people with Tooth Loss in the Anterior Maxilla and Partial Edentulism of the Maxilla, run by Branemarkkliniken at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survival (time frame: Baseline, 1 year, and 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.