Bone Augmentation Techniques in the Mandible Posterior Region
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cortical Shell Bone Grafting.
- Who it may be relevant to
- Registry conditions: Bone Substitutes, Alveolar Bone Grafting. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ecuador
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Bone Augmentation Techniques in the Mandibular Posterior Region: A Randomized Clinical Trial
Overview
This study will compare three methods to rebuild lost bone in the back part of the lower jaw (posterior mandible) before dental implant placement. Seventy-eight adults will be randomly assigned to receive one of three "cortical shell" techniques using either the patient's own bone (autogenous) or prefabricated bone plates from animal (xenogeneic) or human donors (allogeneic). In all groups, the space inside the shell will be filled with a mixture of small bone chips and bone substitute material. The main outcome is the increase in jawbone width measured on 3D cone-beam CT scans at 6 months after surgery. Additional scans and clinical assessments up to 12 months will evaluate healing, bone stability, and postoperative recovery.
Interventions
- Procedure Cortical Shell Bone Grafting
Surgical reconstruction of atrophic posterior mandibular ridges using thin cortical plates fixed with titanium microscrews to form a biologic shell. The inner space is filled with a 1:1 mixture of autogenous bone chips and biomaterial. Depending on the study group, the cortical plates are autogenous (from the mandibular ramus), xenogeneic (bovine origin), or allogeneic (human donor).
Primary outcome measures
- Horizontal Bone Gain (mm) Measured by CBCT [Time frame: 6 after surgery]
Secondary outcome measures (6)
- Surgical Duration (minutes) [Time frame: Day 0 (intraoperative measurement)]
- Relative Radiographic Density Using CBCT Gray Value Units [Time frame: 3, 6, and 12 months after surgery]
- Postoperative Inflammation (mm Facial Measurement) [Time frame: Preoperative, immediate postoperative, days 3, 7, and 14]
- Volumetric Bone Gain (mm³) [Time frame: 3, 6, and 12 months after surgery]
- Morphometric Surface Deviation (mm) [Time frame: 3, 6, and 12 months after surgery]
- Secondary Horizontal Bone Gain at 3 and 12 Months [Time frame: 3 and 12 months after surgery]
Eligibility criteria
Inclusion criteria
Posterior mandibular edentulism requiring horizontal ridge augmentation (Cawood \& Howell Classes IV-VI).
One or two eligible posterior mandibular sites suitable for cortical shell augmentation.
Adequate residual bone height to allow safe fixation above the mandibular canal.
Good general health (ASA I or II). Plaque index < 20% and absence of active periodontal infection. Ability and willingness to attend scheduled follow-up visits (up to 12 months). Written informed consent provided prior to any study-related procedure.
Exclusion criteria
Uncontrolled systemic diseases affecting bone healing (e.g., uncontrolled diabetes mellitus, immunosuppressive disorders).
Current heavy smoking (>5 cigarettes/day). Pregnancy or lactation. Current use of medications known to affect bone metabolism or healing (e.g., bisphosphonates, long-term corticosteroids, anticoagulants).
Active periodontal disease or untreated oral infection. History of chemotherapy or radiotherapy to the head and neck region.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Ecuador · 1 center
- Universidad Espíritu Santo — Samborondón
Identifiers
NCT: NCT06661447 · 2024-ODONT-002