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

NCT07031232 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-14

No results posted yet for this 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.

Conditions

  • Peri-implant Soft Tissue Healing
  • Soft Tissue Management in Subcrestal Dental Implants
  • Healing Abutment Influence on Gingival Volume

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • University of Valencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-07-31
Completion
2029-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07031232 on ClinicalTrials.gov