Effect of Integrating 3D Facial Scanning in Full-Arch Implant Prosthetics: Time Efficiency and Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Total Oral Health Impact Profile-14 (OHIP-14) Score at Trial-Wear Timepoint
研究概览
简要总结
This study compares two ways of planning the bite (jaw-relation) stage of full-arch, implant-supported dental prosthesis treatment: a standard digital approach, and the same approach with the addition of 3D facial scanning, which lets the dental team plan the new teeth against a scan of the patient's own face. The study measured how patients felt about their treatment using a validated questionnaire, and also tracked how many clinic visits and adjustments each approach needed. Twenty-two patients took part, randomly assigned to one of the two approaches.
详细描述
Full-arch implant-supported prosthetic rehabilitation requires accurate jaw-relation recording, which determines both the functional relationship between the arches and the esthetic integration of the final prosthesis within the patient's face. Conventional digital workflows rely on intraoral scanning and wax-rim jaw-relation techniques without reference to extraoral facial anatomy. This prospective, randomized, single-center pilot trial compared a conventional-digital hybrid workflow (Group A) with an enhanced digital workflow incorporating 3D facial scanning (Group B) in patients undergoing full-arch, implant-supported maxillary prosthetic rehabilitation (All-on-6 configuration). All patients received six implants placed using a fully guided surgical protocol with a stackable surgical guide, followed by an immediately loaded PMMA provisional prosthesis during a three-month osseointegration period. Following healing, patients were randomly allocated (computer-generated sequence, allocation concealed by an independent third party) to Group A or Group B for the prosthetic (jaw-relation recording) phase. In Group B, 3D facial scanning was merged with intraoral scans and CBCT data to guide prosthetic design against facial reference planes. The primary outcome was patient-reported oral health-related quality of life, measured using the validated short-form Oral Health Impact Profile (OHIP-14) questionnaire, administered after four weeks of intraoral trial wear of the try-in prosthesis (T1) and again four weeks after delivery of the definitive prosthesis (T2). Secondary outcomes included the number of clinical appointments and chairside adjustments required to complete the prosthetic phase, and implant/prosthesis survival at six months. The definitive prosthesis in both groups consisted of a milled cobalt-chromium framework with layered zirconia, with a mutually protected occlusal scheme. Outcome assessment (clinical/technical evaluation and statistical analysis) was blinded; blinding of patients and the treating clinician was not feasible given the visibly different nature of the two workflows.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) indicated for full-arch maxillary implant-supported fixed prosthetic rehabilitation
- •Completion of the surgical phase with stable implant osseointegration
- •Presence of healthy peri-implant soft tissues
- •Adequate oral hygiene status
- •Sufficient bone and soft-tissue conditions compatible with full-arch prosthetic rehabilitation
- •Ability to comply with all scheduled follow-up visits
- •Capacity to maintain natural head position during facial scanning procedures
- •Absence of significant gag reflex interfering with scanning/impression procedures
- •Ability to communicate effectively and complete questionnaires
- •Provision of written informed consent
- •Physically and psychologically fit for the planned treatment
排除标准
- •Severe skeletal or orthognathic discrepancies
- •History of significant facial trauma or surgery affecting facial symmetry
- •Prior maxillofacial pathology affecting the surgical/prosthetic site
- •Uncontrolled systemic diseases affecting healing or treatment tolerance
- •Use of medications that alter osseointegration or facial soft tissues
- •Active oral or peri-implant infection
- •Neuromuscular disorders or temporomandibular joint dysfunction affecting jaw positioning
- •Conditions affecting the ability to maintain stable head position for scanning
- •Severe psychomotor limitations
- •Known hypersensitivity to materials used in bite registration or prosthesis fabrication
- •Inability or unwillingness to provide informed consent
- •Pregnancy or lactation, if deemed a contraindication by the supervising clinician
- •Poor compliance or demonstrated unreliability in past dental or medical care
研究组 & 干预措施
Conventional-Digital Hybrid Workflow
aw-relation recording using intraoral digital scanning, digitally fabricated bite blocks, and a traditional wax-rim jaw-relation technique with facebow transfer and mechanical articulator mounting, without facial scanning.
干预措施: Conventional-Digital Jaw-Relation Workflow (Procedure)
Enhanced Digital Workflow with 3D Facial Scanning
Same base digital workflow as Group A, with the addition of high-resolution 3D facial scanning (Shining 3D structured-light scanner), merged with intraoral scans and CBCT data via Exocad software to guide prosthetic alignment against extraoral facial landmarks.
干预措施: 3D Facial Scanning-Guided Jaw-Relation Workflow (Procedure)
结局指标
主要结局
Total Oral Health Impact Profile-14 (OHIP-14) Score at Trial-Wear Timepoint
时间窗: 4 weeks
Patient-reported oral health-related quality of life, 14 items across 7 domains, scored 0-56 (higher = worse). Assessed after the patient had worn the try-in (trial) prosthesis intraorally for four weeks (T1).
Total Oral Health Impact Profile-14 (OHIP-14) Score at Post-Delivery Timepoint
时间窗: 4 weeks
Patient-reported oral health-related quality of life, 14 items across 7 domains, scored 0-56 (higher = worse). Assessed four weeks after delivery of the definitive prosthesis (T2).
次要结局
- Number of Clinical Appointments to Complete the Prosthetic Phase(up to 12 weeks)
- Number of Try-In Adjustments(up to 8 weeks)
- Implant and Prosthesis Survival / Complications at 6 Months(6 months post-delivery)
研究者
Lamiaa Farouk
Associate Professor
Ain Shams University