Guided Bone Regeneration With Custom Made Meshes
Guided Bone Regeneration With Custom Made Meshes in the Dental Rehabilitation of Three Dimensional and Extended Defect of the Jaws.
調査の概要
状態
詳細な説明
The implant-borne rehabilitation of three-dimensional and extended alveolar defects is not simple in any case: anatomic and prosthetic demands often require bone reconstructive procedures. Up to date, we can entirely virtually simulate our treatment .The design and printing of a customized mesh mimicking the ideal reconstruction eliminate the intra-operative handling and trimming, with reduced surgical timings and minimal stress for the soft tissues.
The aim is to verify if virtual planning with a customized scaffold could improve the predictability of a complex bone reconstruction in terms of bone reconstruction and implant results.
Twenty patients underwent a guided bone regenerative procedure with the application of a virtually projected customized mesh as containment and stabilizer of particulate bone graft. The entity of bone volume reconstructed after healing were digitally analysed on radiological imaging and expressed in volumetric data and in percentage of what planned before the operation. This datum was correlated with predictors variables potentially affecting the final result: six months at least after surgery, a new cone-beam CT was taken;the pre-and postoperative CT datasets were converted into three-dimensional models and digitally aligned; the reconstructed bone volumes (RBV) were calculated according to the planned bone volumes (PBVs), outlining the areas under the mesh. These values were correlated with complications, atrophies' location and the entity of virtually planned bone volume. As secondary outcome the implant results after the prosthetic loading was evaluated in terms of survival, success and complication.
研究の種類
入学 (実際)
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:
- The presence of horizontal and vertical alveolar defects in both jaws, inadequate for the placement of at least two fixtures, even ≤6 mm long ones;
- ≥ 18 years;
- informed consent signed.
Exclusion Criteria:
- acute or chronic infections in the head and neck;
- smoking >10 cigarettes per day;
- uncontrolled diabetes (glycated hemoglobin level > 7 mg/dL);
- a history of radiation therapy in the head or neck region;
- current antitumor chemotherapy;
- liver, blood, or kidney disease;
- immunosuppression;
- everyday corticosteroid use;
- pregnancy;
- inflammatory and autoimmune disease of the oral cavity;
- poor oral hygiene and motivation
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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Subjects undergoing virtually planned GBR for extended and complex alveolar defects.
Subjects undergoing virtually planned GBR for extended and complex alveolar defects. The subjects were selected from the population of patients referring to the Oral & Maxillofacial Surgery Unit of S.Orsola-Malpighi University Hospital for oral function rehabilitation. Eligibility criteria were: the presence of horizontal and vertical alveolar defects in both jaws, inadequate for the placement of at least two fixtures, even ≤6 mm long ones; ≥ 18 years; informed consent signed. |
After local anesthesia, the surgery started with a mid-crestal incision with vertical releasing cuts followed by the full-thickness buccal and lingual/palatal flaps raising to expose the bone defect completely.
The flaps were coronally extended to assure a complete closure with a passive suture above the titanium.
Subsequently, an intra-oral mandibular ramus bone cortical block was harvested in the molar zone.
The bone block was milled and mixed with freeze-dried.
The particulate graft was put to fill the deficit above the mesh until its perfect stability and unity with the defect's borders.
Two or three titanium mini-screws were used to stabilize the device , and the flaps were carefully sutured.
Ceftriaxone was administered intravenously at a loading dose of 2 g; together with a non-steroidal analgesic, it was continued at two g/die per os beginning the day after surgery and continuing for six days.
他の名前：
|
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 |
|---|---|---|
|
Bone regeneration volumes
時間枠：6 months after surgery
|
The bone reconstruction was calculated comparing the pre-operative and postoperative volumes.
The Reconstructed Bone Volume (RBV) derived by subtracting the Lacking Bone Volume (LBV) values from Planned Bone Volume (PBV) ones.
The pre-and postoperative CT datasets were converted into 3D models using Amira imaging software, version 5.3.3.
The segmentation regarded almost the entire jaw structure to have at least six precise anatomical points of matching for the superimposition.
After that, the pre and postoperative models were digitally aligned with Geomagic Studio 12 software.
After the alignment was verified at a minimum range of tolerance of error level of ±0.37 mm in the areas no involved by the surgery, the measurements were performed.
In every single slice, the space between the mesh profile and the basal bone was virtually selected and rendered to obtain the PBV; the area representative for the empty space according to the gray-scale of pixels was rendered for the LBV.
|
6 months after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Implant survival.
時間枠：1 year after implant loading at least.
|
The number of implants in function at the end of follow-up was recorded
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1 year after implant loading at least.
|
|
Complication rate
時間枠：through study completion, an average of 2 years.
|
The number of complications (peri-implantitis, infections, prosthetic fractures, soft tissue problems) was recorded and expressed in numerical data.
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through study completion, an average of 2 years.
|
|
Implant success
時間枠：1 year after implant loading at least.
|
The implant succes was calculated in respect to the bone resorption around each implant, radiographically assessed: with a dedicated software, the distance between the implant shoulder and the higher point of bone-implant contact was measured mesially and distally, attributing a mean value to each implant.
These measures, expressed in millimeters, were recorded and reported as numerical data.
|
1 year after implant loading at least.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Giuseppe lizio, DDS、University of Bologna (Italy) UNIBO
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
その他の研究ID番号
- 121/2013
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
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