Guided Root Slice Replantation vs. Socket Shielding for Immediate Implant Placement in Esthetic Zone
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
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Hussein F Hussein, PhD
- Telefonnummer: +201092452350
- E-Mail: hussein.fathy@mu.edu.eg
Studienorte
-
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Minya Governorate
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Minya, Minya Governorate, Ägypten, 61512
- Rekrutierung
- Faculty of Dentistry, Minia University
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Kontakt:
- Hussein F Hussein, PhD
- Telefonnummer: +201092452350
- E-Mail: Hussein.fathy@mu.edu.eg
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
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Selected patients of both sexes are 20-40 years old.
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Patients are systemically healthy based on questionnaire dental modification of Cornell index.
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Clinical gingival health either on intact or reduced periodontium according to the new classification system (2017). (Lang, N. P. et al., 2018)
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The recipient site of the implant is free from any active pathological conditions.
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Class II extraction socket according to Sabri and Barootchi classification ( Sabri, H.
et al., 2024)
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Adequate interocclusal space to accommodate the available restorative components.
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Adequate native/apical bone to achieve primary implant stability.
Exclusion Criteria:
- Pregnant female.
- Parafunctional habits such as bruxism and clenching Patients suffering from periodontitis.
- Smokers.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 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. |
|
Aktiver Komparator: 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. |
|
Aktiver Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Labial Bone Thickness
Zeitfenster: 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
Zeitfenster: 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
|
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Accuracy of AI-Assisted Digital Planning
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Bone Density
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
|
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Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- MiniaU128-1322
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