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Guided Root Slice Replantation vs. Socket Shielding for Immediate Implant Placement in Esthetic Zone

2026年9月22日 更新者:Hussein Fathy Mohammad Hussein Abo Elkheir、Minia University

Artificial Intelligence Integrated Planning and Evaluation of Novel Fully Guided Autogenous Root Slice Replantation and Fully Guided Socket Shielding in Immediate Esthetic Implant Placement (Randomized Clinical Trial)

The goal of this clinical trial is to learn whether two different tooth-preservation techniques work equally well when placing a dental implant right after a tooth is removed in the front of the mouth (the "esthetic zone"). It will also learn whether using artificial intelligence (AI) to help plan the surgery improves the results.

The main questions it aims to answer are:

  • Does keeping part of the root in place using a technique called autogenous root slice replantation work as well as a similar technique called socket shielding, in terms of appearance and gum health around the implant?
  • Does AI-guided surgical planning improve accuracy, appearance, and gum health compared with traditional planning?

Researchers will compare participants who receive autogenous root slice replantation to participants who receive the socket-shield technique to see if one produces better outcomes than the other. Both groups will have their implants placed using a 3D-printed surgical guide made from AI-assisted digital planning.

Participants will:

  • Have a tooth removed and an implant placed on the same day, using one of the two techniques
  • Have their surgery guided by a custom surgical guide, planned with AI assistance
  • Return for follow-up visits so researchers can check healing, gum appearance, and how well the implant fits with their smile

調査の概要

状態

募集

条件

介入・治療

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

    • Minya Governorate
      • Minya、Minya Governorate、エジプト、61512
        • 募集
        • Faculty of Dentistry, Minia University
        • コンタクト:

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

20年~40年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Selected patients of both sexes are 20-40 years old.

  2. Patients are systemically healthy based on questionnaire dental modification of Cornell index.

  3. Clinical gingival health either on intact or reduced periodontium according to the new classification system (2017). (Lang, N. P. et al., 2018)

  4. The recipient site of the implant is free from any active pathological conditions.

  5. Class II extraction socket according to Sabri and Barootchi classification ( Sabri, H.

    et al., 2024)

  6. Adequate interocclusal space to accommodate the available restorative components.

  7. Adequate native/apical bone to achieve primary implant stability.

Exclusion Criteria:

  1. Pregnant female.
  2. Parafunctional habits such as bruxism and clenching Patients suffering from periodontitis.
  3. 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:ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Fully Single Guided Socket Shield

Participants in this arm will undergo the socket-shield technique for immediate implant placement using a single, fully guided digital protocol. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct both the sectioning of the facial root fragment (shield preparation) and the immediate implant osteotomy and placement in one continuous, fully guided sequence. The facial root fragment will be retained to support the labial bone plate and peri-implant soft tissues, while immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health.

A single, AI-planned surgical guide is used to perform both root sectioning and implant osteotomy/placement in one uninterrupted guided sequence. The facial (buccal) portion of the natural root is intentionally retained in situ - decoronated and prepared to a defined sub-crestal height and thickness under full guidance - to preserve the labial bone plate and periodontal ligament-derived vascularity. The implant is placed immediately palatal/lingual to the shield, and immediate provisionalization is performed. This differs from conventional socket-shield protocols, which typically use freehand or dual-guide sequences (separate guides for sectioning and implant placement).

Implant placement performed on the same day as tooth extraction, using a single, AI-assisted, fully guided digital surgical protocol common to all three study arms. Pre-operative digital planning (integrating CBCT and intraoral scan data with AI-assisted analysis) is used to determine implant position, angulation, and depth, and to design a single surgical guide. This guide directs the osteotomy and implant insertion, standardizing implant positioning across all arms regardless of the labial defect-management technique used (socket shield, ARSR, or bone augmentation). This shared, standardized component allows the trial to isolate the effect of the labial defect-management technique on esthetic and peri-implant outcomes, since implant placement accuracy is controlled identically across groups.

アクティブコンパレータ:Fully Guided Autogenous Root Slicing Replantation

Participants in this arm will undergo the autogenous root slice replantation (ARSR) technique for immediate implant placement using a single, fully guided digital protocol. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct both the sectioning and preparation of the autogenous root slice and the immediate implant osteotomy and placement in one continuous, fully guided sequence. The prepared root slice will be replanted and retained facially within the socket to support the labial bone plate and peri-implant soft tissues, while immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health.

Implant placement performed on the same day as tooth extraction, using a single, AI-assisted, fully guided digital surgical protocol common to all three study arms. Pre-operative digital planning (integrating CBCT and intraoral scan data with AI-assisted analysis) is used to determine implant position, angulation, and depth, and to design a single surgical guide. This guide directs the osteotomy and implant insertion, standardizing implant positioning across all arms regardless of the labial defect-management technique used (socket shield, ARSR, or bone augmentation). This shared, standardized component allows the trial to isolate the effect of the labial defect-management technique on esthetic and peri-implant outcomes, since implant placement accuracy is controlled identically across groups.

A single, AI-planned surgical guide directs both the harvesting/slicing of an autogenous root segment and the immediate implant osteotomy and placement in one continuous guided workflow. Unlike the socket-shield technique, the root slice is sectioned and then replanted (repositioned) facially within the fresh socket as a free graft, rather than left attached in its native position. The slice is guided to a standardized dimension, position, and depth to support the labial plate and soft tissue architecture. Immediate provisionalization is performed. This is the first reported application of full digital/AI guidance to the ARSR technique.

アクティブコンパレータ:Conventional Bone Augmentation

Participants in this arm will undergo immediate implant placement combined with conventional guided bone grafting to manage any labial bone defects (dehiscence or fenestration), rather than a partial extraction therapy technique. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct the immediate implant osteotomy and placement. Bone graft material and a barrier membrane will be used to restore the labial bone defect at the time of implant placement, and immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health.

Implant placement performed on the same day as tooth extraction, using a single, AI-assisted, fully guided digital surgical protocol common to all three study arms. Pre-operative digital planning (integrating CBCT and intraoral scan data with AI-assisted analysis) is used to determine implant position, angulation, and depth, and to design a single surgical guide. This guide directs the osteotomy and implant insertion, standardizing implant positioning across all arms regardless of the labial defect-management technique used (socket shield, ARSR, or bone augmentation). This shared, standardized component allows the trial to isolate the effect of the labial defect-management technique on esthetic and peri-implant outcomes, since implant placement accuracy is controlled identically across groups.

Immediate implant placement is performed using a single AI-planned surgical guide for implant osteotomy and positioning only (no root-sectioning component). Any labial dehiscence or fenestration defect present after extraction is managed using the current gold-standard approach: particulate bone graft material placed against the defect and covered with a barrier membrane to guide bone regeneration. No tooth root structure is retained. Immediate provisionalization is performed. This arm serves as the active control, isolating the effect of partial extraction therapy (root retention) from AI-guided implant placement alone.

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
Labial Bone Thickness
時間枠:through study completion, an average of 1 year

Labial bone plate thickness measured via cone-beam computed tomography (CBCT) to evaluate preservation of the labial bone contour following autogenous root slice replantation (ARSR), socket shield, or conventional bone augmentation.

through study completion, an average of 1 year
Marginal Bone Level
時間枠:through study completion, an average of 1 year

Radiographic marginal bone level around the implant, assessed via CBCT, to evaluate crestal bone stability across the three treatment groups.

through study completion, an average of 1 year
Accuracy of AI-Assisted Digital Planning
時間枠:through study completion, an average of 1 year

AI-based segmentation of the tooth/root to be sectioned will be compared against human (manual) segmentation using a heat map to quantify the average discrepancy between the two, assessing the accuracy and reliability of AI integration in surgical planni

through study completion, an average of 1 year

二次結果の測定

結果測定
メジャーの説明
時間枠
Bone Density
時間枠:through study completion, an average of 1 year

Peri-implant bone density assessed labially and proximally via CBCT.

through study completion, an average of 1 year
Peri-Implant Probing Depth
時間枠:through study completion, an average of 1 year

Clinical probing depth around the implant measured at multiple sites.

through study completion, an average of 1 year
Modified Gingival Index
時間枠:through study completion, an average of 1 year

Clinical assessment of peri-implant soft tissue inflammation.

through study completion, an average of 1 year
Modified Plaque Index
時間枠:through study completion, an average of 1 year

Clinical assessment of plaque accumulation around the implant.

through study completion, an average of 1 year
Keratinized Tissue Width and Thickness
時間枠:through study completion, an average of 1 year

Width and thickness of keratinized mucosa surrounding the implant, measured clinically.

through study completion, an average of 1 year
Pink Esthetic Score (PES) scaled from 0 to 2
時間枠:through study completion, an average of 1 year

Validated index evaluating the esthetic appearance of the peri-implant soft tissues.

through study completion, an average of 1 year
White Esthetic Score (WES)
時間枠:through study completion, an average of 1 year

Validated index evaluating the esthetic appearance of the implant-supported crown.

through study completion, an average of 1 year
Postoperative Pain (Visual Analog Scale)
時間枠:through study completion, an average of 1 year

Patient-reported pain intensity measured using a Visual Analog Scale (VAS).

through study completion, an average of 1 year
AI Utility in Postoperative Follow-Up
時間枠:through study completion, an average of 1 year

AI-assessed proposed implant fixture position compared against the actual postoperative position, to evaluate the utility and accuracy of AI in follow-up assessment.

through study completion, an average of 1 year

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。

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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。

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6月16日

一次修了 (推定)

2027年11月1日

研究の完了 (推定)

2028年3月30日

試験登録日

最初に提出

2026年9月4日

QC基準を満たした最初の提出物

2026年9月22日

最初の投稿 (実際)

2026年9月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月28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22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

その他の研究ID番号

  • MiniaU128-1322

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

米国で製造され、米国から輸出された製品。

いいえ

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