3D-Printed PLA Guide Versus Resin Guide in Mandibular Molar Implant Placement (CGIIPMM-PLA-MR)
2026年9月12日 更新者：Mohamed Esmail Ahmed Hassan
Computer Guided Immediate Implant Placement in Mandibular Molars Using Patient Specific 3D Printed Polylactic Acid Guide Versus Modified Resin Guide
This randomized clinical trial compares two tooth-supported computer-guided surgical guide systems for immediate implant placement in mandibular molar extraction sockets: a patient-specific 3D-printed PLA guide system and a modified resin guide system.
The study evaluates implant positioning accuracy, primary implant stability, and surgical time.
調査の概要
状態
完了
詳細な説明
This randomized clinical trial compares two tooth-supported computer-guided surgical guide systems for immediate implant placement in mandibular molar extraction sockets: a patient-specific 3D-printed polylactic acid (PLA) guide system and a modified resin guide system. Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and fabrication of the surgical guides.
Implant positioning accuracy was assessed by comparing the planned and actual implant positions using preoperative and postoperative CBCT datasets. Angular deviation, coronal deviation at the implant platform, and apical deviation were recorded.
Primary implant stability was assessed immediately after implant placement using Implant Stability Quotient (ISQ) measurements obtained with an Osstell device. Surgical time was recorded from seating of the surgical guide and initiation of osteotomy until completion of implant insertion.
The study was designed to compare the performance of the two guide systems in immediate mandibular molar implant placement.
研究の種類
介入
入学 (実際)
20
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。
研究場所
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New Cairo
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Cairo、New Cairo、エジプト、11511
- Future University in Egypt (FUE)
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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 20-50 years.
- Non-restorable mandibular first molar indicated for extraction.
- Sufficient bony support for implant placement without the need for significant bone augmentation.
- Good oral hygiene and motivation.
- Adequate prosthetic space.
- Ability and willingness to undergo the surgical procedure and follow-up.
- Suitable for computer-guided, tooth-supported implant placement.
Exclusion Criteria:
- Uncontrolled systemic diseases that may impair healing (e.g., uncontrolled diabetes or hypertension).
- Severe periodontal disease.
- Patients undergoing chemotherapy or radiotherapy.
- Insufficient prosthetic space.
- Heavy smokers.
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：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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 PLA guide
Immediate implant placement in mandibular molar extraction sockets using a patient-specific tooth-supported 3D-printed PLA surgical guide system.
Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and guide fabrication.
The guide was fabricated from PLA according to the planned implant position.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guide's guiding channel according to the planned trajectory, followed by immediate implant insertion.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
|
Preoperative virtual planning was performed using CBCT data and digital intraoral scans.
The datasets were used for prosthetically driven implant planning and fabrication of a patient-specific 3D-printed PLA surgical guide.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guiding channel according to the planned implant position and trajectory.
The implant was then immediately inserted.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
|
|
アクティブコンパレータ：Modified Resin guide
Immediate implant placement in mandibular molar extraction sockets using a tooth-supported modified resin surgical guide system.
Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and guide fabrication.
The guide was fabricated from light-cured surgical-guide resin according to the planned implant position.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guide's guiding channel according to the planned trajectory, followed by immediate implant insertion.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
|
Preoperative virtual planning was performed using CBCT data and digital intraoral scans.
The datasets were used for prosthetically driven implant planning and fabrication of a tooth-supported modified resin surgical guide.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guiding channel according to the planned implant position and trajectory.
The implant was then immediately inserted.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
|
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 implant position
時間枠：Assessed within 1 week postoperatively, following acquisition of the postoperative CBCT scan.
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Accuracy of implant placement will be evaluated by comparing the planned implant position from the preoperative digital plan with the actual implant position obtained from the postoperative CBCT scan.
Deviations will be assessed in three dimensions, including angular deviation (degrees), coronal deviation (platform) (mm), and apical deviation (mm).
Measurements will be performed using specialized implant-planning software by superimposing the preoperative and postoperative datasets.
Lower deviation values indicate greater agreement between the planned and actual implant positions.
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Assessed within 1 week postoperatively, following acquisition of the postoperative CBCT scan.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
primary implant stability by osstell
時間枠：Measured immediately at the time of implant placement during the surgical procedure.
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Primary implant stability will be assessed using an Osstell device, which measures Implant Stability Quotient (ISQ) values through resonance frequency analysis.
A SmartPeg will be attached to the implant, and ISQ readings will be taken in two perpendicular directions (buccolingual and mesiodistal).
Higher ISQ values indicate greater mechanical stability.
The mean ISQ value for each implant will be recorded and used for analysis
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Measured immediately at the time of implant placement during the surgical procedure.
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surgical time
時間枠：Assessed intraoperatively, measured during the surgical appointment, and recorded immediately after surgery
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Surgical time will be recorded to evaluate the procedural efficiency of guided immediate implant placement.
Time will be measured from seating of the surgical guide and initiation of osteotomy until completion of implant insertion.
The total duration will be recorded in minutes.
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Assessed intraoperatively, measured during the surgical appointment, and recorded immediately after surgery
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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。
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
- Shi Y, Wang J, Ma C, Shen J, Dong X, Lin D. A systematic review of the accuracy of digital surgical guides for dental implantation. Int J Implant Dent. 2023 Oct 25;9(1):38. doi: 10.1186/s40729-023-00507-w.
- Ragucci GM, Elnayef B, Criado-Camara E, Del Amo FS, Hernandez-Alfaro F. Immediate implant placement in molar extraction sockets: a systematic review and meta-analysis. Int J Implant Dent. 2020 Oct 13;6(1):40. doi: 10.1186/s40729-020-00235-5.
- Ku JK, Lee J, Lee HJ, Yun PY, Kim YK. Accuracy of dental implant placement with computer-guided surgery: a retrospective cohort study. BMC Oral Health. 2022 Jan 16;22(1):8. doi: 10.1186/s12903-022-02046-z.
- Pieralli S, Spies BC, Hromadnik V, Nicic R, Beuer F, Wesemann C. How Accurate Is Oral Implant Installation Using Surgical Guides Printed from a Degradable and Steam-Sterilized Biopolymer? J Clin Med. 2020 Jul 22;9(8):2322. doi: 10.3390/jcm9082322.
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)
2025年11月2日
一次修了 (実際)
2026年8月10日
研究の完了 (実際)
2026年9月10日
試験登録日
最初に提出
2026年9月12日
QC基準を満たした最初の提出物
2026年9月12日
最初の投稿 (実際)
2026年9月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年9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9月12日
最終確認日
2026年9月1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
- FUE.REC(78)/10-2025
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
IPD プランの説明
Individual participant data will not be shared because of participant privacy and confidentiality considerations.
Only aggregate study results will be reported.
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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
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