Assessment of Peri-implant Soft Tissue Modifications Following the Use of Customized Healing Abutments on Subcrestally Placed Implants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Dimensional changes in the peri-implamt soft tissue
研究概览
简要总结
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.
详细描述
Background and Rationale:
Peri-implant soft tissue health and stability are essential factors influencing the long-term success of dental implants, especially in terms of aesthetic outcomes and biological integration. A well-formed and stable mucosal seal around the implant protects the underlying bone, supports tissue homeostasis, and contributes to the overall functional and esthetic result of implant-supported prostheses.
Healing abutments are temporary components used during the transgingival healing phase to help shape the emergence profile and guide soft tissue adaptation prior to final prosthetic restoration. The design, diameter, and customization of the healing abutment may significantly affect peri-implant soft tissue volume, thickness, contour, and recession patterns. Recent research has suggested that minimizing disruption to the peri-implant mucosa (i.e., using a one abutment-one time approach) and optimizing soft tissue support during healing can result in improved tissue preservation and enhanced esthetic outcomes.
However, there is limited clinical evidence comparing the effect of different healing abutment designs-particularly standard, wide, and customized abutments-on the volumetric and linear changes in peri-implant soft tissues, especially when implants are placed subcrestally in healed ridges. This study aims to address that gap through a randomized controlled clinical trial using modern digital tools for volumetric analysis.
Study Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older.
- •Patients requiring a single dental implant in a healed posterior site (maxilla or mandible).
- •Presence of at least 2 mm of keratinized mucosa at the implant site.
- •Healed alveolar ridge with sufficient bone volume for implant placement without need for guided bone regeneration.
- •Good general and oral health, with controlled plaque and bleeding indices.
- •Insertion torque ≥ 30 Ncm at the time of implant placement.
- •Willingness to comply with study protocol and attend scheduled follow-up visits.
- •Signed informed consent.
排除标准
- •Smoking more than 10 cigarettes per day.
- •Uncontrolled systemic diseases (e.g., uncontrolled diabetes, immunosuppression).
- •History of head or neck radiation therapy.
- •Current or recent use of bisphosphonates.
- •Active periodontal disease or peri-implant infection.
- •Severe parafunctional habits (e.g., bruxism, clenching).
- •Pregnant or breastfeeding women.
- •Previous implant failure at the intended site.
研究组 & 干预措施
Standard Healing Abutment Group
Participants in this group will receive a conventional, prefabricated cylindrical titanium healing abutment placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol.
干预措施: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol Using Healing Abutments (Procedure)
Wide Healing Abutment Group
Participants in this group will receive a prefabricated wide healing abutment with an increased diameter designed to provide broader mucosal support. The abutment will be placed immediately after surgery and will not be removed during healing.
干预措施: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol Using Healing Abutments (Procedure)
Customized Healing Abutment Group
Participants in this group will receive a customized healing abutment fabricated with composite using a preform-phantoma. The abutment will replicate the desired emergence profile of the final prosthesis. It will be placed immediately after surgery and left in place during the healing phase.
干预措施: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol Using Healing Abutments (Procedure)
结局指标
主要结局
Dimensional changes in the peri-implamt soft tissue
时间窗: 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.
次要结局
未报告次要终点
研究者
Juan Carlos Bernabeu Mira
Clinical Professor and Research Director in Oral Surgery and Implantology, Universitat de València
University of Valencia