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临床试验/NCT07381608
NCT07381608已完成不适用

Clinical and Patient-reported Outcomes of Guided Versus Freehand Harvesting Of Positioning of Autogenous Bone Shells: a Randomized Controlled Trial

Shalash Dental education1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年2月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Visual Analogue Scale for Pain (0-10)

研究概览

简要总结

When people lose teeth or have gum disease, the jawbone can shrink over time. This shrinkage makes it difficult for dentists to place dental implants because implants need a strong and stable base of bone. To solve this problem, surgeons often use bone grafting techniques. One of the most reliable ways to rebuild lost bone is called the autogenous shell technique. In this method, very thin plates of bone are taken from another part of the patient's mouth, shaped into a "shell," and fixed into place at the site where bone is missing. The empty space inside the shell is then filled with tiny bone chips, and the whole graft heals into strong new bone over time. Once healed, implants can be placed securely.

This technique has been widely studied and is considered highly effective. However, it is not easy to perform. Traditionally, the shells are harvested and positioned by hand, relying heavily on the skill and experience of the surgeon. Even very experienced clinicians face challenges: the shells can break if cut too thin, positioning may take a long time, and results can vary from patient to patient. Patients also report significant discomfort after surgery, including swelling, pain, and difficulty eating and speaking during recovery.

In recent years, digital technology has begun to transform oral surgery. Using 3D imaging and computer design, it is now possible to create custom surgical guides and positioning jigs. These guides are printed with 3D printers and act like templates, helping surgeons cut bone in exactly the right size and shape, and place it precisely in the planned position. In implant dentistry, such guides are already used for the accurate placement of dental implants, and studies show they can make surgery faster and safer. However, little is known about whether these guides also improve patient comfort and recovery when used in bone grafting procedures such as the shell technique.

This clinical trial has been designed to answer that question. It compares two groups of patients who need vertical bone augmentation before implant placement:

Guided group: Patients treated with 3D-printed surgical guides for harvesting and positioning bone shells.

Freehand group: Patients treated with the conventional freehand shell technique without guides.

By studying both groups, the trial aims to determine whether guided surgery reduces pain, swelling, and recovery problems, and whether it saves time in the operating room. Most importantly, it seeks to put patients' voices at the center by focusing on patient-reported outcome measures (PROMs)-direct feedback from patients about how they feel after the procedure.

详细描述

Why This Trial is Needed. Bone augmentation surgeries are elective procedures. Patients choose them to improve their quality of life through implant-supported teeth. Because these surgeries are optional, patients' comfort, recovery, and satisfaction are especially important. Traditional studies often measure only technical outcomes, such as how much bone is gained or whether implants survive in the long term. While these outcomes are essential, they do not tell the whole story. A patient may have a technically successful bone graft but still feel the experience was very painful or difficult, which could reduce trust in dental care.

The guided shell technique holds promise for reducing patient suffering. By making surgery quicker and more precise, it might limit tissue trauma and shorten healing time. Yet, until now, no high-quality randomized controlled trial (RCT) has compared guided versus freehand shell grafting from the patient's perspective. This lack of evidence is a gap that needs to be filled so that patients and clinicians can make informed choices. If guided surgery proves superior, it could become the new standard of care, ensuring safer and more comfortable treatment for people needing implants.

Purpose of the Study

The main goal of this study is to compare the patient-reported outcomes between guided and freehand autogenous shell grafting. Specifically, the trial will investigate:

How much pain, swelling, bruising, difficulty chewing, and limited mouth opening (trismus) patients experience after surgery.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-99years. Classified as American Society of Anesthesiologists (ASA) I or II.
  • Partial edentulism (missing teeth) requiring ≥4 mm vertical ridge augmentation.
  • Presence of a suitable intraoral donor site for bone harvesting.
  • Good oral hygiene, with Full Mouth Plaque Score (FMPS) < 25%.

排除标准

  • Systemic contraindications to oral surgery (uncontrolled systemic disease). -History of head or neck radiotherapy.
  • Current or past use of bisphosphonates or other medications affecting bone healing.
  • Smokers of more than 10 cigarettes per day.
  • Pregnant or breastfeeding women.
  • Presence of active oral infection at the surgical site.
  • Untreated periodontal disease.

研究组 & 干预措施

Free hand

Active Comparator

Participants in this arm will undergo vertical ridge augmentation using the conventional freehand shell technique. Thin cortical bone plates will be harvested manually from the donor site and positioned at the recipient site without guides, relying on surgeon experience and judgment.

干预措施: Free hand shell technique (Procedure)

Guided shell technique

Experimental

Participants in this arm will undergo vertical ridge augmentation using a digitally guided autogenous shell technique. CBCT and intraoral scan data will be combined for virtual planning of the required graft. Patient-specific surgical guides will be designed and 3D-printed to guide bone-block harvesting and shell positioning. During surgery, the harvesting guide will direct retrieval of the autogenous bone block from the external oblique ridge. After splitting, the cortical shells will be assembled and stabilized extraorally on a 3D-printed model using a positioning/transfer guide and subsequently transferred to the recipient site for fixation. Particulate autogenous bone will be placed between the shells, followed by tension-free primary closure

干预措施: Guided shell technique (Device)

结局指标

主要结局

Visual Analogue Scale for Pain (0-10)

时间窗: 7 days

The Visual Analogue Scale for Pain is a Likert scale (0-10) in which the patient rates pain in response to prespecified questions (Pilowsky and Kaufman, 1965). This is a standard tool for recording subjective measurements, such as pain, into a measurable outcome that can be compared across subjects enrolled in the study. On this scale 0 means there is no pain felt, and 10 is the worst possible pain felt. Lower scores indicate lower pain and higher scores indicate severe pain.

次要结局

  • analgesic intake(7 days)
  • Surgical time(on the day of the surgery ( T1))

研究者

发起方
Shalash Dental education
申办方类型
Other
责任方
Sponsor

研究点 (1)

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