NCT Number: NCT07593131
Risk Factors Associated With Infraposition of Implant Supported Single Crowns in the Anterior Maxilla
Losing a tooth in the front part of the upper jaw can affect both appearance and the ability to bite and chew. Treatment to replace missing teeth is therefore often required. Such treatment may be burdensome for the individual and can involve substantial costs for both the patient and society. A common treatment option is placement of a titanium screw (dental implant) in the jawbone. After a healing period, the implant is restored with a crown designed to resemble a natural tooth.
Replacement of missing teeth with dental implants in the anterior maxilla can be particularly challenging. Over time, the crown of an implant may appear shorter than the adjacent natural teeth. This occurs because natural teeth may continue to change position throughout adulthood, whereas dental implants remain fixed within the bone. As a result, the implant-supported crown may appear to sink relative to neighboring teeth, a phenomenon referred to as infraposition. The prevalence of infraposition and the factors contributing to its development are not yet fully understood.
The aim of this study is to determine the frequency and extent of infraposition and to identify potential contributing factors in individuals treated with a single implant-supported crown in the anterior maxilla. The study also aims to evaluate the aesthetic outcome after treatment from both the patient and the clinician perspective.
The study hypothesis is that infraposition occurs in a clinically relevant proportion of patients and that certain factors, such as age at implant placement or individual dental characteristics, may increase the likelihood of its occurrence. It is further hypothesized that infraposition of the implant-supported crown may influence aesthetic appearance and that these changes may be perceived differently by patients and dental professionals.
Through longitudinal follow-up and comparison of repeated digital scans, the study seeks to improve understanding of the occurrence of infraposition, its contributing factors, and its potential impact on the aesthetic outcome of implant-supported crowns over time.
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Prosthodontic Departments at Folktandvården Eastmaninstitutet, Stockholm, Sweden
About this study
This observational cohort study is based on long-term follow-up of patients treated with a single implant-supported crown in the anterior maxilla as part of routine clinical care. Participants are enrolled consecutively from the Departments of Oral Prosthodontics within the Public Dental Service in Region Västerbotten (Umeå) and Public Dental Service Stockholm AB. The study is based on repeated digital recordings of the dentition over time.
At the time of crown delivery, a digital impression is obtained using an intraoral scanner to create three-dimensional digital models of the dental arches and their spatial relationship. Additional digital impressions are obtained during scheduled follow-up visits at 1, 3, and 5 years after delivery, in accordance with routine implant follow-up clinical practice. An additional follow-up visit using the same procedures is performed at 10 years. Digital models obtained at different time points are superimposed and compared using proprietary software associated with the intraoral scanner. This enables measurement of positional changes of the adjacent teeth realtive to the implant-supported crown. Changes over time are recorded and used to assess the occurrence and degree of infraposition.
At each follow-up visit, participants undergo standard clinical and radiographic evaluation of the implant-supported crown, including assessment of peri-implant soft tissues, marginal bone levels, implant stability, occlusion, and oral hygiene conditions. Radiographic imaging follows standardized regional clinical guidelines and is identical to that used in routine implant follow-up.
Data collected for analysis include demographic variables, sex, age at implant placement, medical history and medications, lower anterior face height, pre-prosthetic orthodontic treatment, cause of tooth loss, smile line, type of temporary restoration, implant type (bone-level or tissue-level), implant manufacturer, augmentation procedures, implant position, restoration type (screw-retained or cement-retained), use of a temporary implant-supported single crown, and occlusion or articulation on the implant-supported single crown.
The aesthetic outcome of the implant-supported crown is assessed using both objective and subjective evaluation methods. Objective evaluation is based on standardized clinical and digital criteria derived from three-dimensional models and clinical examinations. Subjective evaluation includes patient-reported assessments of aesthetic satisfaction using a questionnaire.
Follow-up time points are recorded for all participants. Data are collected using a predefined protocol to ensure standardized documentation across study sites. Source data are obtained from clinical dental records and digital scan files. All data are handled in accordance with national patient data legislation and the General Data Protection Regulation (GDPR).
Statistical analyses are planned to explore correlations between infraposition and patient-related, anatomical, and treatment-related factors, as well as correlations between infraposition, marginal bone level changes, and aesthetic evaluations over time.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients over 18 years of age who had received an Implant Supported Single Crown in the anterior maxilla (canine to canine) were eligible for inclusion.
Treatment and study plan
Primary outcomes
-
Infraposition
Time frame: From enrollment until the end of the study, 10 years after the last study participant is recruited.
Outcome Measure 1 Title: Frequency of Infraposition of Implant-Supported Single Crowns Description: Proportion of patients with infraposition of an implant-supported single crown relative to adjacent teeth in the anterior maxilla after crown delivery.
Unit of Measure: Percentage (%) of patients
Outcome Measure 2 Title: Extent of Infraposition of Implant-Supported Single Crowns Description: Displacement of adjacent teeth relative to implant-supported single crown in the anterior maxilla after crown delivery.
Unit of Measure: Millimeters (mm)
Outcome Measure 3 Title: Correlation between Extent of Infraposition and Contributing Factors Description: Correlation of infraposition extent (mm) with sex, age at implant placement, medical history/medication, facial height, orthodontic treatment, cause of tooth loss, smile line, temporary restoration, implant and restoration characteristics, augmentation procedures, implant position, and occlusion/articulation.
Unit of Measure: Millimeters(mm)
Secondary outcomes
-
Aesthetic evaluation
Time frame: From enrollment until the end of the study, 10 years after the last study participant is recruited.
To evaluate aesthetic outcomes at baseline and follow-up using both subjective and objective evaluation methods.
Secondary Outcome Measure 1 Title: Patient-Reported Aesthetic Outcome Description: Patient-reported aesthetic satisfaction with implant-supported single crowns.
Unit: VAS (0-100 mm) and ordinal scale (1-4) Tool: Patient questionnaire using a visual analogue scale and a four-level satisfaction scale
Secondary Outcome Measure 2 Title: Clinician-Reported Aesthetic Outcome Description: Clinician-reported aesthetic evaluation of implant-supported single crowns.
Unit: VAS (0-100 mm) and ordinal scale (1-4) Tool: Clinician assessment using VAS and a four-level ordinal scale
Secondary Outcome Measure 3 Title: Objective Aesthetic Outcome (PES and WES) Description: Objective evaluation of peri-implant soft-tissue and crown-related aesthetics of implant-supported single crowns.
Unit: PES and WES scores (0-10) Tool: Clinician assessment using PES and WES
Study contacts
Contact information is provided by the study sponsor or research team.
Cecilia Turborn, DDS
CONTACT
Nicole Winitsky, DDS, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Region Västerbotten
Other Gov
Collaborators
- Umeå University
Registry information
Official study title
Risk Factors Associated With Infraposition of Single-tooth Implants in the Anterior Maxilla
Important dates
- Study start
- 2021
- Primary completion
- 2036
- Study completion
- 2036
- First posted
- May 18, 2026
- Registry last updated
- May 18, 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.