Accuracy of CAD/CAM Cutting Guides and Customized Titanium Plates for Virtual Planning Transfer in Bimaxillary Orthognathic Surgeries
調査の概要
状態
介入・治療
詳細な説明
Intervention:
Diagnostic procedure:
All Patients will be selected according to inclusion and exclusion criteria & Comprehensive clinical examination and understanding of patients' chief complains and needs will be carried out.
Preoperative patient photographs (Frontal, Profile, 45°, smile, and dental occlusion).
Alginate Impressions of upper & lower jaws will be taken for acquiring diagnostic dental casts.
A heat-cured acrylic resin stent will be constructed on the stone model. Using the stent, a radiographic stent will be constructed for imaging and planning procedures.
Cone Beam Computed Topography (CBCT) for the patients will be carried out. All patients will be referred to an orthodontist for presurgical phase of orthodontic treatment for decompensation and to attain stable occlusion in three points in the surgery.
Planning procedure:
All planning procedures are carried out by MZ and under the supervision of AH and MH.
Computer-aided planning & MCROS design for all patients: All planning will be done using specialized software .
One virtual 3D anatomic model of the patient will be constructed through thresholding & image fusion.
Virtual Le Fort I osteotomy and then the maxilla will be virtually adjusted according to the facial symmetry planes and clinical anthropometric analysis. Virtual simulation of the sagittal split of the mandible will be performed and the mandible position adjusted according to the bite registered.
After settling on the optimum virtual plan, designing of the cutting guides and titanium plates will then be started.
Intra-operative procedures:
The surgical procedures will be carried out by MZ under the supervisor of AH in the Oral & Maxillofacial operating floor on the 8th floor of the faculty of Oral & Dental Medicine new building.
Scrubbing and draping of the patient will be carried out in a standard fashion according to Anon 2006.
Local anaesthesia (lidocaine 2%, 1/100000 adrenaline) will be injected intraorally along the incision lines for hemostasis.
Access through a vestibular intraoral incision for maxilla & Sagittal split incision for mandible will be carried out. Dissection and reflection to reach the bone will be carried out.
Le Fort I Maxillary & Bilateral Sagittal split mandibular osteotomies will be carried out using the osteotomy cutting guides.
Complete mobilization of maxillary and mandibular segments. Reposition and fixation of the maxillary & mandibular segments using customized titanium plates.
The incisions will be closed with continuous mattress resorbable sutures .
Post-operative care:
Patients will start antibiotics 4 hours after the last intraoperative dose (Amoxicillin / Clavulanic acid 625 mg every 8 hours) for 5 days Patients will start analgesics (NSAIDs every 6 hours) for 3 days Mouthwash (Chlorhexidine 0.12%) will be prescribed for 2 more weeks.
Criteria for discontinuing or modifying intervention:
- Difficulty with the use of cutting guides and customized titanium plates.
- Inaccurate translation of the surgical plan.
Strategies to improve adherence to intervention:
Postoperative orthodontic treatment is necessary after the operation to obtain the final stable occlusion.
Concomitant care:
Not needed.
- Follow up & Evaluation:
Post-operative treatment will start immediately postoperative (4 hours). The patients will be scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months.
Within the first week postoperatively CBCT using same parameters will be ordered to calculate the difference between surgical plan and actual outcome will be evaluated.
Patient will be referred back to the orthodontist to receive his postsurgical orthodontics 4-6 weeks postoperatively.
The technique will be evaluated by applying hard tissue parameters to compare the virtual orthognathic planning (P0) with the postoperative result (P1) using 3D cephalometry and image fusion.
研究の種類
入学 (予想される)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
- Patients with no signs or symptoms of active TMDs.
- Highly motivated patients.
Exclusion Criteria:
- Patients who refused to be included in the research.
- Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
研究計画
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:study group
using CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches.
|
patients with maxillofacial disharmony will undergo orthognathic surgery using CAD/CAM Cutting Guides and Customized Titanium Plates.
|
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 |
|---|---|---|
|
Accuracy of the surgical transfer
時間枠:within first week postoperatively
|
Computer software on pre/postoperative CBCT
|
within first week postoperatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient satisfaction: Visual analog scale (questionnaire)
時間枠:one week postoperative
|
Visual analog scale (questionnaire)
|
one week postoperative
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- Dr.Zain protocol
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?
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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
米国FDA規制機器製品の研究
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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-
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