Clinical trial NCT06942013: Radiographic Assessment of Guided Cortical Shell Technique for Horizontal Ridge Augmentation
Official title: Radiographic Assessment of Cortical Shell Technique For Horizontal Ridge Augmentation In The Anterior Mandible Using Full Digital Workflow Versus Free Hand Protocol: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Horizontal Ridge Deficiency
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Type: Parallel, two arms, randomized controlled trial Allocation ratio: 1:1 Framework: Equivalence
Primary purpose: TREATMENT

Brief summary: The protocol outlines a randomized clinical trial comparing two surgical techniques for horizontal ridge augmentation in the anterior mandible:

Computer-Guided Autogenous Cortical Shell Technique (using a patient-specific guide for precise placement).

Free-Hand Autogenous Cortical Shell Technique (traditional approach without a guiding template).

Key Points:

The study aims to determine which method provides better accuracy and bone volume stability.

Cone Beam CT scans (CBCT) will assess horizontal bone gain preoperatively and six months postoperatively.

The trial is conducted at Cairo University's Faculty of Dentistry. Participants: Patients with pure horizontal bone loss in the anterior mandible.

Outcomes:

Primary: Bone width gain in millimeters. Secondary: Accuracy of augmentation and surgical time.

Methodology:

The study group will use computer-designed surgical osteotomy guides to harvest and place bone grafts with improved precision.

The control group will rely on the conventional free-hand approach. Both groups will undergo bone grafting using autogenous cortical bone shells.

Data Collection \& Analysis:

Participants will be randomized and blinded. Data will be analyzed using statistical methods to compare effectiveness.

Detailed description: This randomized controlled trial evaluates the clinical effectiveness and surgical accuracy of a computer-guided versus a conventional free-hand approach for horizontal ridge augmentation in the anterior mandible using the autogenous cortical shell technique.

Participants presenting with horizontal alveolar bone deficiency in the anterior mandible are randomly assigned to one of two groups:

Study Group: A fully digital workflow is employed, including CBCT-based virtual planning and the use of 3D-printed, patient-specific stereolithographic guides for both bone harvesting and graft placement.

Control Group: The traditional free-hand technique is used without computer-guided assistance.

The study is designed to assess whether the digital, guided approach enhances horizontal bone gain, optimizes graft placement accuracy, reduces operative time, and lowers complication rates compared to the free-hand protocol.

The intervention involves preoperative 3D planning, surgical guide fabrication, and intraoperative bone harvesting and grafting. Both groups receive autogenous cortical bone blocks harvested from the mandibular symphysis and secured at the recipient site with mini screws. Bone particulate (autogenous + xenograft, 1:1 ratio) is used to augment volume.

Primary outcome is the amount of horizontal bone gain measured via CBCT superimposition at baseline and 6 months postoperatively. Secondary outcomes include surgical time, accuracy of graft placement, and incidence of postoperative complications such as pain, swelling, infection, dehiscence, or graft exposure.

This single-center, single-blinded equivalence trial uses a 1:1 randomization ratio. Ethical approval has been obtained, and participants provide informed consent prior to enrollment. The results are expected to inform surgical best practices and improve the predictability of mandibular ridge augmentation procedures.This randomized controlled trial evaluates the clinical effectiveness and surgical accuracy of a computer-guided versus a conventional free-hand approach for horizontal ridge augmentation in the anterior mandible using the autogenous cortical shell technique.

Participants presenting with horizontal alveolar bone deficiency in the anterior mandible are randomly assigned to one of two groups:

Study Group: A fully digital workflow is employed, including CBCT-based virtual planning and the use of 3D-printed, patient-specific stereolithographic guides for both bone harvesting and graft placement.

Control Group: The traditional free-hand technique is used without computer-guided assistance.

The study is designed to assess whether the digital, guided approach enhances horizontal bone gain, optimizes graft placement accuracy, reduces operative time, and lowers complication rates compared to the free-hand protocol.

The intervention involves preoperative 3D planning, surgical guide fabrication, and intraoperative bone harvesting and grafting. Both groups receive autogenous cortical bone blocks harvested from the mandibular symphysis and secured at the recipient site with mini screws. Bone particulate (autogenous + xenograft, 1:1 ratio) is used to augment volume.

Primary outcome is the amount of horizontal bone gain measured via CBCT superimposition at baseline and 6 months postoperatively. Secondary outcomes include accuracy of graft placement, and surgical time.

This single-center, single-blinded equivalence trial uses a 1:1 randomization ratio. Ethical approval has been obtained, and participants provide informed consent prior to enrollment. The results are expected to inform surgical best practices and improve the predictability of mandibular ridge augmentation procedures.

Eligibility criteria: Inclusion Criteria:

* • Anterior mandible with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually.

  * Class IV and V according to Cawood and Howell classification.
  * No sex predilection.
  * Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
  * The minimum number of missing teeth in the anterior mandible alveolar ridge is two adjacent teeth.
  * Normal vertical dimension with normal inter-arch space.

Exclusion Criteria:

* • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.

  * General contraindications to implant surgery.
  * Subjected to irradiation in the head and neck area less than 1 year before implantation.
  * Untreated periodontitis.
  * Poor oral hygiene and motivation.
  * Uncontrolled diabetes.
  * Pregnant or nursing females.
  * Immunosuppressed or immunocompromised
  * Heavy smokers
  * Patients who undergo medication interfere with bone healing
  * Previous grafting procedures in the edentulous area.

Primary outcomes:
measure: Alveolar Ridge Horizontal Bone Gain
timeFrame: (CBCT) scans are taken preoperatively and 6 months postoperatively to evaluate bone changes. Superimposition of CBCT images is performed using Mimics 21.0 software (Materialise, Belgium) to assess bone augmentation
Secondary outcomes:
measure: Accuracy of the Computer-assisted guide in the study group
timeFrame: Measured at: 6 months postoperatively using CBCT scans.
measure: Intraoperative Time
timeFrame: During surgery by using a stopwatch.
Other outcomes:
Locations:
Study officials:
References: