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

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.

Conditions

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

Interventions

DEVICE

scannable anatomical healing abutment

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.

DEVICE

Standard Healing Abutment for Dental Implants

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.

Sponsors & Collaborators

• Indiana University

  collaborator OTHER

• ITI International Team for Implantology, Switzerland

  collaborator OTHER

• Institut Straumann AG

  collaborator INDUSTRY

• University of Illinois at Chicago

  lead OTHER

Principal Investigators

• Luis Mezzomo, PhD · University of Illinois at Chicago

• Waldemar Polido, PhD · Indiana University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2028-03-31

Completion

2028-09-30

FDA Device

Yes

Countries

• United States

Study Locations