NCT07845019

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jun 2026Mar 2028

Study Start

First participant enrolled

June 16, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

1.4 years

First QC Date

September 4, 2026

Last Update Submit

September 22, 2026

Conditions

TEETH EXTRACTIONEsthetic Zone ImplantologySocket Shield Technique Implant PlacementRoot SlicingGuided Surgery Accuracy

Outcome Measures

Primary Outcomes (3)

  • Labial Bone Thickness

    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

    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

    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

Secondary Outcomes (9)

  • Bone Density

    through study completion, an average of 1 year

  • Peri-Implant Probing Depth

    through study completion, an average of 1 year

  • Modified Gingival Index

    through study completion, an average of 1 year

  • Modified Plaque Index

    through study completion, an average of 1 year

  • Keratinized Tissue Width and Thickness

    through study completion, an average of 1 year

  • +4 more secondary outcomes

Study Arms (3)

Fully Single Guided Socket Shield

ACTIVE COMPARATOR

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.

Procedure: Guided socket shield with immediate implantProcedure: Guided Immediate Implant

Fully Guided Autogenous Root Slicing Replantation

ACTIVE COMPARATOR

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.

Procedure: Guided Autogenous Root Slicing Replantation with Immediate ImplantProcedure: Guided Immediate Implant

Conventional Bone Augmentation

ACTIVE COMPARATOR

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.

Procedure: Conventional Bone Augmentation with Immediate ImplantProcedure: Guided Immediate Implant

Interventions

Guided socket shield with immediate implantPROCEDURE

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).

Fully Single Guided Socket Shield
Guided Autogenous Root Slicing Replantation with Immediate ImplantPROCEDURE

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.

Fully Guided Autogenous Root Slicing Replantation
Conventional Bone Augmentation with Immediate ImplantPROCEDURE

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.

Conventional Bone Augmentation
Guided Immediate ImplantPROCEDURE

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.

Conventional Bone AugmentationFully Guided Autogenous Root Slicing ReplantationFully Single Guided Socket Shield

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Selected patients of both sexes are 20-40 years old.
  • Patients are systemically healthy based on questionnaire dental modification of Cornell index.
  • Clinical gingival health either on intact or reduced periodontium according to the new classification system (2017). (Lang, N. P. et al., 2018)
  • The recipient site of the implant is free from any active pathological conditions.
  • Class II extraction socket according to Sabri and Barootchi classification ( Sabri, H.
  • et al., 2024)
  • Adequate interocclusal space to accommodate the available restorative components.
  • Adequate native/apical bone to achieve primary implant stability.

You may not qualify if:

  • Pregnant female.
  • Parafunctional habits such as bruxism and clenching Patients suffering from periodontitis.
  • Smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Minia University

Minya, Minya Governorate, 61512, Egypt

RECRUITING

Related Publications (1)

  • Alfertshofer M, Gebhart F, Nolte D. Template-Guided Autogenous Tooth Transplantation Using a CAD/CAM Dental Replica in a Complex Anatomical Scenario: A Case Report. Dent J (Basel). 2025 Jun 23;13(7):281. doi: 10.3390/dj13070281.

    PMID: 40710126BACKGROUND

Central Study Contacts

Hussein F Hussein, PhD

CONTACT

+201092452350hussein.fathy@mu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 28, 2026

Study Start

June 16, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

March 30, 2028

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)