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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT07727980
Status
Not Yet Recruiting

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Conditions

  • Clinical Trials
  • Dental Implant
  • Immediate Dental Implant Placement
  • MANDIBLE
  • Maxilla
  • Molar Extraction Socket
  • Randomized Controlled Trial
  • Tooth Loss

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • scannable anatomical healing abutment — DEVICE
    The 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 — DEVICE
    The 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.

Study Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AHA Group
    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.
  • Active Comparator: Conventional Healing Abutment Group
    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.

Primary Outcome Measure

Three-dimensional (3D) peri-implant soft tissue volumetric changes within the region of interest (ROI) [ Time Frame: From enrollment to the end of treatment at 12 months follow-up ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Illinois Chicago College of DentistryChicagoIllinois60612
Megan Dietrich, Clinical Research Coordinator
[email protected]
312-996-7226
Indiana University School of DentistryIndianapolisIndiana46202
Waldemar Polido, PhD
[email protected]
317-922-5835

Find similar trials in Chicago, IL

By research site
University of Illinois Chicago College of Dentistry· Chicago, ILIndiana University School of Dentistry· Indianapolis, IN

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