Radiographic Assessment of Guided Cortical Shell Technique for Horizontal Ridge Augmentation (NCT06942013) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Radiographic Assessment of Guided Cortical Shell Technique for Horizontal Ridge Augmentation
20 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range
20 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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