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Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction. (3DFACE)

2026年6月11日 更新者：Tishreen University

Evaluation of the Effectiveness of Patient-Specific 3D-Printed Titanium Facial Implants in the Reconstruction and Aesthetic Correction of Facial Defects: A Clinical Study

This clinical study aims to evaluate the effectiveness of patient-specific 3D-printed titanium facial implants in the reconstruction and aesthetic correction of facial defects. The study will include patients presenting with congenital, traumatic, or post-surgical facial deformities requiring reconstructive intervention.

Eligible participants will undergo preoperative clinical assessment and radiological imaging to design customized implants using computer-aided design (CAD) and 3D printing technology. The implants will be fabricated from medical-grade titanium and surgically placed according to standardized maxillofacial reconstructive protocols.

Postoperative follow-up will assess functional outcomes, implant stability, complication rates, and aesthetic improvement over a defined observation period. Outcome evaluation will include clinical examination and patient-reported satisfaction measures.

The objective of this study is to determine whether patient-specific 3D-printed titanium implants provide reliable functional restoration and improved aesthetic outcomes in facial reconstruction compared to conventional reconstructive techniques.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Background:

Facial bone defects and contour deformities may result from congenital anomalies, trauma, tumor resection, cystic lesions, or developmental deficiencies. Conventional reconstructive techniques often rely on standard implants or intraoperative modification of grafts, which may not provide optimal anatomical adaptation or aesthetic outcomes.

Recent advances in three-dimensional (3D) imaging, computer-aided design (CAD), and additive manufacturing technologies have enabled the production of patient-specific titanium implants tailored to the unique anatomy of individual patients. These implants may improve surgical precision, reduce operative time, enhance facial symmetry, and provide more predictable functional and aesthetic outcomes.

Objective:

This clinical study aims to evaluate the effectiveness, safety, and clinical performance of patient-specific 3D-printed titanium facial implants in the reconstruction and aesthetic correction of facial defects.

Methods:

Eligible adult patients presenting with facial bone defects, facial asymmetry, congenital deformities, post-traumatic defects, or aesthetic indications requiring customized facial augmentation will undergo preoperative imaging using computed tomography (CT). Patient-specific titanium implants will be designed using computer-aided design software and manufactured using 3D-printing technology.

Clinical evaluation will include assessment of implant fit accuracy, facial symmetry, aesthetic outcomes, postoperative complications, patient satisfaction, and overall treatment success. Follow-up assessments will be performed at regular intervals for up to 12 months after surgery.

Expected Outcomes:

The study is expected to demonstrate that patient-specific 3D-printed titanium implants provide accurate anatomical reconstruction, improved facial aesthetics, high patient satisfaction, and acceptable safety profiles when used for facial reconstruction and contour correction.

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Age 18 years or older.
  • Presence of facial bone defects resulting from cystic or tumoral osteolytic lesions.
  • Acquired or congenital facial deformities associated with bony defects or facial asymmetry.
  • Patients requiring patient-specific 3D-printed titanium implants for maxillofacial reconstruction.
  • Aesthetic indications requiring custom facial implant design, including microgenia (chin retrusion).
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Active pathological lesions at the time of enrollment.
  • Age below 18 years.
  • History of radiotherapy within 12 months prior to enrollment.
  • Chronic untreated vitamin D deficiency.
  • Uncontrolled diabetes mellitus.
  • Inability or unwillingness to comply with follow-up requirements.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Patient-Specific 3D-Printed Titanium Implant Reconstruction Group

Participants in this study will undergo reconstruction of facial defects using patient-specific three-dimensional (3D)-printed titanium implants. Preoperative planning will be performed using clinical assessment and high-resolution radiographic imaging to design customized implants tailored to each patient's anatomical defect. The implants will be fabricated from medical-grade titanium using additive manufacturing technology.

Surgical reconstruction will be performed under standard maxillofacial surgical protocols. The customized titanium implants will be positioned and fixed to restore both functional integrity and facial aesthetics. Postoperative follow-up will include clinical evaluation, radiographic assessment, and monitoring for complications, implant stability, and aesthetic outcomes over the defined study period.
手順：Patient-specific titanium implants for facial reconstruction

Patient-specific 3D-printed titanium implants will be used for reconstruction of facial bone defects and correction of facial deformities. Each implant will be individually designed based on high-resolution computed tomography (CT) imaging and three-dimensional virtual surgical planning (VSP) using computer-aided design (CAD) software to accurately match the patient's anatomical defect.

The implants will be manufactured from medical-grade titanium alloy (Ti6Al4V) using selective laser melting (SLM) additive manufacturing technology. Post-processing will include surface finishing and sterilization prior to surgical use.

Surgical placement will be performed under general anesthesia following standard maxillofacial surgical protocols. The customized implants will be fixed to the native bone using titanium fixation screws when required to restore facial contour, structural support, and symmetry.

Postoperative follow-up will include clinical and radiological assessment using CT imaging t

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Postoperative Complication Rate
時間枠：From surgery up to 6 months postoperatively
Assessment of postoperative complications following reconstruction with patient-specific 3D-printed titanium implants. Complications include infection, implant exposure, implant failure, or the need for revision surgery. Each patient will be assigned a binary score: 0 = no postoperative complication and 1 = presence of one or more postoperative complications. The outcome will be evaluated and recorded by the treating surgeon during the follow-up period. Higher values indicate a greater complication rate.
From surgery up to 6 months postoperatively
Outcome Measure Title: Implant Geometric Accuracy Assessed by 3D Deviation Analysis
時間枠：Immediately after laser-based 3D printing of the implant and before surgical implantation.
Assessment of the geometric accuracy of the patient-specific 3D-printed titanium implant by performing three-dimensional scanning of the manufactured implant and comparing it with the original digital design using 3D deviation analysis software. Accuracy will be quantified as the root mean square (RMS) deviation between the scanned implant and the planned digital model. Lower deviation values indicate higher manufacturing accuracy.
Immediately after laser-based 3D printing of the implant and before surgical implantation.
Aesthetic Improvement Score
時間枠：3 months after surgery
Assessment of facial symmetry following reconstruction using a standardized 5-point facial symmetry scale evaluated by an independent plastic surgeon. Scores range from 1 (severe asymmetry) to 5 (excellent symmetry). Higher scores indicate better aesthetic outcomes.
3 months after surgery

二次結果の測定

結果測定
メジャーの説明
時間枠
Total Operative Time (Minutes)
時間枠：During surgery
Assessment of the total duration of the surgical procedure, measured from skin incision to wound closure and recorded in minutes. Operative time will be compared with historical data from conventional reconstruction techniques. Lower values indicate greater surgical efficiency.
During surgery
Patient Satisfaction Score Using a 10-Point Visual Analog Scale (VAS)
時間枠：3 months after surgery
Assessment of patient satisfaction with the reconstructive outcome using a 10-point Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. Higher scores indicate greater patient satisfaction.
3 months after surgery

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Tishreen University

捜査官

  • スタディチェア：Basim A Slim、Tishreen University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月26日

一次修了 (推定)

2026年11月1日

研究の完了 (推定)

2026年11月1日

試験登録日

最初に提出

2026年6月5日

QC基準を満たした最初の提出物

2026年6月11日

最初の投稿 (実際)

2026年6月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月17日

QC基準を満たした最後の更新が送信されました

2026年6月11日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • latakia-univ-2100
  • 1739 (その他の識別子：Scientific Research Council Decision No. 1739)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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