Artificial Intelligence-Guided Versus Manual CBCT Planning for Immediate Implant Placement in Molar Extraction Sites: A Randomized Controlled Trial
Trial ID: NCT07459036
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-03-03
Completion date: 2026-05-02
Sponsor: Shalash Dental education
Conditions: Dental Implant; Immediate Implant; Guided Bone Regeneration
Interventions: AI assisted CBCt; Manual CBCT segmentation
Locations: Shalash Implant education
Countries: Egypt
Enrollment: 80
Age range: 18 Years - 99 Years
Sex: ALL

Summary:
This study evaluates whether artificial intelligence (AI)-based analysis of cone-beam computed tomography (CBCT) scans can support clinical decision-making for immediate dental implant placement in molar extraction sites.

When a molar tooth is removed, placing a dental implant immediately may reduce treatment time and preserve surrounding bone. However, immediate implant placement is not always possible and depends on the anatomy of the extraction socket, particularly the interradicular septum (the bone between the roots). CBCT imaging is routinely used to assess this anatomy before surgery. Traditionally, radiologists manually evaluate these scans. Recently, AI-based tools have been developed to automatically analyze CBCT images.

In this randomized controlled trial, patients requiring molar extraction and potential immediate implant placement will be assigned to one of two planning approaches: AI-guided CBCT assessment or conventional manual CBCT assessment. The operating surgeon will use the assigned planning report to guide treatment decisions.

The primary outcome of the study is the feasibility of immediate implant placement, defined as successful implant placement with achievement of primary stability during surgery. Secondary outcomes include surgical time, need for changes to the treatment plan, and implant stability measurements.

The goal of this study is to determine whether AI-assisted CBCT analysis performs similarly to, or improves upon, conventional manual radiologic assessment in supporting safe and effective immediate implant placement.

Eligibility criteria:
Inclusion Criteria:

* Adults≥18 years are able to provide informed consent. Indicated for the extraction of a molar tooth (maxillary or mandibular) with planned implant-supported rehabilitation.
* Candidate for immediate implant placement attempt based on preoperative clinical evaluation and CBCT availability.
* Preoperative CBCT will be acquired using the study imaging protocol within a defined window (e.g., ≤4 weeks before surgery).
* Adequate oral hygiene and periodontal condition compatible with implant surgery (e.g., treated/stable periodontal status per clinician judgement).

Exclusion Criteria:

* Pregnancy or breastfeeding (due to imaging/surgical considerations).
* Uncontrolled systemic disease or medical contraindication to oral surgery/implant placement (e.g., uncontrolled diabetes, immunosuppression as judged by clinician).
* History of head and neck radiotherapy in the implant region. Use of medications associated with compromised bone healing where immediate implant placement is not advised (e.g., high-dose antiresorptives/IV bisphosphonates; you can specify per your clinic policy).
* Acute uncontrolled infection at the site requiring staged management (e.g., spreading cellulitis/abscess) or other condition precluding immediate placement per surgeon judgement.
* Need for simultaneous major augmentation that precludes immediate implant placement (e.g., extensive ridge reconstruction planned at the same surgery rather than socket-level grafting).
* Inadequate CBCT quality for segmentation/measurement (motion artifacts, incomplete field of view, or metal artifact obscuring the septum).

Outcomes:
Immediate implant feasability