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Tissue Preservation in Immediate 1C Implants Using an Anatomical Prefabricated Healing Abutment

Not Yet RecruitingNA

Sponsor: University of Illinois at Chicago

Conditions: Tooth Loss, Dental Implant, Clinical Trials, Randomized Controlled Trial, Immediate Dental Implant Placement

Interventions: scannable anatomical healing abutment, Standard Healing Abutment for Dental Implants

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 20 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.
* Willing to perform tasks associated with the study and to attend all study visits.

Exclusion Criteria:

* HbA1c \>6.5%) as per a chairside test (Siemens Bayer DCA 2000+);
* smoker (any status);
* immunodeficiency;
* history of head and neck radiotherapy;
* intake of bone anti-resorptive drugs;
* cysts or tumors in the area;
* self-reported pregnancy;
* poor oral hygiene;
* active periodontal disease;
* acute endodontic infection and pus discharge on the site itself and adjacent areas;
* lack of mutually protected occlusion;
* insufficient inter-occlusal clearance (\<15 mm);
* sites with an existing midfacial mucogingival recession/deficiency (scar tissue);
* sites with a high-scalloped, thin biotype.

Those who appear to qualify will have a CBCT scan taken with an open bite and proper retractions of the cheek, lips, and tongue (standard of care), and the following inclusion criteria, based on the CBCT results, must be present in order for the subject to be fully enrolled in the study:

* Sites with an intact or minimally damaged facial bone plate measuring greater than 1 mm in thickness;
* Sites with at least 5 mm of healthy bone between the socket apex and the relevant anatomical structure (e.g., the maxillary sinus floor in the maxilla or the inferior alveolar nerve, submandibular/sublingual fossa, mental foramen, or anterior loop of the inferior alveolar nerve in the mandible);
* In multirooted molar sockets, the presence of a short root trunk and an interradicular septum with a minimum height of 5 mm and a thickness of 3 mm.

Locations (2)

Chicago, Illinois, United States
Indianapolis, Indiana, United States