이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 9월 22일 업데이트: 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

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Minya Governorate
      • Minya, Minya Governorate, 이집트, 61512
        • 모병
        • Faculty of Dentistry, Minia University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.

활성 비교기: 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.

활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Labial Bone Thickness
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Bone Density
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 16일

기본 완료 (추정된)

2027년 11월 1일

연구 완료 (추정된)

2028년 3월 30일

연구 등록 날짜

최초 제출

2026년 9월 4일

QC 기준을 충족하는 최초 제출

2026년 9월 22일

처음 게시됨 (실제)

2026년 9월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 22일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • MiniaU128-1322

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .