The goal of this clinical trial is to evaluate whether an anatomical prefabricated healing abutment (AHA) improves tissue preservation and clinical outcomes following immediate implant placement after tooth extraction in adults. Although immediate implant placement is a well-established treatment for replacing missing teeth, healing can result in changes to the surrounding bone and soft tissues that may affect the esthetic appearance, function, and long-term stability of the implant-supported restoration. This study will compare an anatomical healing abutment, designed to mimic the natural tooth emergence profile and support peri-implant tissues during healing, with a conventional healing abutment. The primary objectives are to determine whether the AHA better preserves soft tissue contours and alveolar bone, improves implant positioning accuracy and tissue stability during healing, and differs from a conventional healing abutment in complications or adverse events. Eligible participants will be adults requiring extraction of a hopeless tooth in the posterior maxilla or mandible who are suitable candidates for immediate implant placement. Following tooth extraction and implant placement, participants will receive either an anatomical prefabricated healing abutment or a conventional healing abutment and will return for scheduled follow-up visits over approximately 12 months to assess healing, implant stability, and changes in the surrounding hard and soft tissues. Researchers will collect clinical measurements, digital intraoral scans, photographs, and radiographic images throughout the study. Additional research imaging will be used to generate three-dimensional models to measure tissue volume changes and implant position accuracy. Specialized software will compare changes between the two groups over time. Safety will be evaluated by monitoring participants for complications, discomfort, inflammation, implant-related problems, and other adverse events throughout follow-up. All procedures will be performed by trained dental professionals using established clinical protocols. The results may improve understanding of how healing abutment design influences tissue preservation after immediate implant placement and help optimize future implant therapy by supporting better functional, esthetic, and long-term outcomes.
Willing to sign an IRB-approved informed consent and HIPAA authorization form prior to participation.
Between the ages of 20 and 75 years old.
ASA Classification I and II.
Hopeless maxillary or mandibular posterior teeth, eligible for immediate implantation, and with intact/successfully restored adjacent teeth.
HbA1c >6.5%) as per a chairside test (Siemens Bayer DCA 2000+);
smoker (any status);
immunodeficiency;
history of head and neck radiotherapy;
Parallel
scannable anatomical healing abutment
DeviceThe anatomical prefabricated healing abutment (AHA) is a dental implant healing component specifically designed to reproduce the natural emergence profile of the extracted tooth and provide anatomical support to the peri-implant soft tissues during the healing phase following immediate implant placement. Unlike conventional healing abutments, which typically have a standardized cylindrical shape, the AHA is designed with an anatomical contour intended to better maintain the 3D shape and volume of the soft tissues surrounding the implant. The intervention consists of placement of the AHA immediately after implant insertion and its use throughout the healing period until delivery of the definitive implant-supported restoration. The effectiveness of the AHA will be evaluated by comparing three-dimensional soft tissue volume changes, tissue contour preservation, bone remodeling, implant positioning outcomes, and clinical parameters with those observed using a conventional healing abutment.
Standard Healing Abutment for Dental Implants
DeviceThe conventional healing abutment is a standard prefabricated healing component used during the healing phase following dental implant placement. Unlike the anatomical prefabricated healing abutment evaluated in the experimental group, it has a standardized, generally cylindrical contour and is not specifically designed to replicate the natural emergence profile of the extracted tooth. After implant placement, it is connected to the implant to allow the surrounding soft tissues to heal and establish an appropriate peri-implant tissue contour before placement of the definitive implant-supported restoration. The intervention consists of the placement and maintenance of the conventional healing abutment during the healing period according to standard clinical practice. Outcomes will be compared with the anatomical prefabricated healing abutment group to evaluate differences in soft tissue volume preservation, tissue contour changes, bone remodeling, and other clinical parameters.
Three-dimensional (3D) peri-implant soft tissue volumetric changes within the region of interest (ROI)
To assess soft tissue three-dimensional (3D) volumetric changes by calculating the percentage variation in cubic millimeters (% mm³) within defined regions of interest (ROI), using superimposed consecutive digital surface models (intraoral scans) obtained at pre-extraction (T1), impression (T3), baseline/prosthesis delivery (T4), 6 months (T5), and 12 months (T6), at the Geomagic® metrology software. This endpoint will assess the ability of the scannable anatomical healing abutment to preserve peri-implant soft tissue contours following immediate implant placement. Longitudinal changes will be analyzed using mixed-effects models to evaluate the interaction between treatment group and time.
Mid-facial mucosal margin (MM) level
Will be measured vertically in millimeters using a periodontal probe positioned perpendicular to a horizontal reference line connecting the cementoenamel junctions (CEJs) of the adjacent teeth.
Keratinized mucosa width (KMW)
Distance in millimeters from the mid-facial mucosal margin to the mucogingival line.
Pink Esthetic Score (PES)
The peri-implant soft tissues will be evaluated by visual assessment using the Pink Esthetic Score (PES) described by Furhauser et al. (2005). The in total PES ranges from 0 to 14 and assesses seven parameters: mesial papilla, distal papilla, level of the gingival margin, soft tissue contour, alveolar process, soft tissue color, and soft tissue texture, with each parameter scored from 0 to 2.
Implant position accuracy
Implant position accuracy will be assessed by quantifying three-dimensional linear (millimeters) and angular (degrees) deviations between the planned and final implant positions, using pre- and post-operative CBCT scans and the "Treatment Evaluation" tool in coDiagnostiX® software.
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
Indiana University
Collaborator
ITI International Team for Implantology, Switzerland
Collaborator
Institut Straumann AG
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
