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NCT07727980

Overview

NCT ID: NCT07727980
Lead Sponsor: University of Illinois at ChicagoOTHER
Official Title: Tissue Preservation in Immediate 1C Implants Using an Anatomical Prefabricated Healing Abutment
Brief Summary: 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Sep 2026Estimated
Primary Completion Date: Mar 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Luis Mezzomo, PhDContact
lmezzomo@uic.edu312-996-3535

Similar Studies

Participant Group/Arms

AHA GroupExperimental

Participants assigned to the experimental group will receive a prefabricated anatomical healing abutment (AHA) following immediate implant placement after tooth extraction. The AHA is a healing component designed to better reproduce the natural emergence profile of the extracted tooth and provide anatomical support to the surrounding peri-implant soft tissues during the healing period. After placement of the dental implant, the anatomical prefabricated healing abutment will be connected to the implant and maintained throughout the initial healing phase until the definitive implant-supported restoration is provided according to standard clinical procedures. The intervention is intended to evaluate whether maintaining a more natural tissue contour during healing improves preservation of peri-implant soft tissue volume and stability compared with a conventional healing abutment. Participants will undergo routine clinical follow-up evaluations to measure changes in the soft tissues.

Device: scannable anatomical healing abutment

Conventional Healing Abutment GroupActive Comparator

Participants assigned to the control group will receive a conventional healing abutment following immediate implant placement after tooth extraction. The conventional healing abutment represents the standard approach commonly used during the implant healing phase and is designed to allow the surrounding soft tissues to heal and form an appropriate contour around the implant site before placement of the definitive implant-supported restoration. Following implant placement, the conventional healing abutment will be connected to the implant and maintained during the initial healing period according to standard clinical protocols. Participants will undergo the same follow-up schedule and evaluations as the experimental group. Data collected during the 12-month follow-up period will be used to compare changes in peri-implant soft tissue contour, tissue volume preservation, bone remodeling, implant stability, and other clinical outcomes between the control and test groups.