Comparative Clinical Study of Conventional vs Customized Healing Abutments in Dental Implantology

Condition(s) studied

Investigational drug(s) / intervention(s)

Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol Using Healing Abutments: All participants will receive a single bone-level dental implant placed in a healed posterior site of the maxilla or mandible. The implants will be placed using a biological drilling protocol and inserted with a final torque of at least 30 Ncm. A 2 mm transmucosal one-piece abutment (mono-block) will be connected at the time of surgery, following a one abutment-one time philosophy. Each patient will receive a healing abutment immediately after implant placement according to their allocated study group (standard, wide, or customized). The assigned healing abutment will not be removed throughout the healing period. All procedures will be carried out under local anesthesia in a standard clinical setting.

Study summary

This clinical study evaluates how different healing abutment designs influence the healing and preservation of the soft tissues surrounding dental implants. Healing abutments are temporary components placed on implants during the healing phase to help shape the gum tissue before placing the final crown or prosthesis. The way these components interact with the gum tissue may affect the long-term stability, volume, and aesthetics of the peri-implant soft tissue.

All participating patients will receive bone-level dental implants placed approximately 2 mm below the bone crest (subcrestal position). The study will include three groups of patients, each receiving a different type of healing abutment:

Group 1 (Control): will receive a standard cylindrical healing abutment.

Group 2: will receive a wide healing abutment with an enlarged base to support more soft tissue volume.

Group 3: will receive a customized healing abutment designed using digital intraoral scanning and CAD/CAM technology, intended to replicate the final prosthetic emergence profile.

The goal is to evaluate which type of healing abutment helps to preserve the natural volume and shape of the gum tissue most effectively during the healing period. The primary focus will be on measuring changes in soft tissue volume and thickness around the implants over time.

Participants will undergo digital intraoral scans before surgery and at 3, 6, and 12 months after implant placement. These scans will be used to assess how the gum tissue changes in response to each type of abutment using 3D analysis and software-based measurements.

This study is important because maintaining healthy and stable soft tissue around dental implants plays a crucial role in achieving successful, long-lasting, and aesthetically pleasing results. By understanding how healing abutment design affects tissue healing, clinicians may be better equipped to select the most appropriate healing protocol for each patient.

Eligibility

Primary outcome measure(s)

• Dimensional changes in the peri-implamt soft tissue — Preoperative, the day of the intervention and a follow up until 12 months
  Soft tissue changes will be assessed using digital intraoral scans obtained at baseline, immediately after surgery, and at 3, 6, and 12 months. STL files will be superimposed using 3D analysis software based on stable anatomical landmarks. Volumetric and linear changes will be calculated within defined buccal and interproximal regions of interest (ROIs). Parameters include soft tissue volume (mm³), thickness (mm), and gingival margin displacement. Color-coded deviation maps will visualize contour stability. All measurements will be performed in duplicate by calibrated, blinded evaluators. This method offers accurate, reproducible, and non-invasive assessment of peri-implant soft tissue dynamics.

Trial sites (1)

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