An interventional study of Cortical Shell Bone Grafting in Bone Substitutes and Alveolar Bone Grafting, sponsored by Universidad de Especialidades Espiritu Santo. Not yet recruiting at 1 site in Ecuador. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Universidad de Especialidades Espiritu Santo · Not applicable, Interventional, and Treatment
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.
318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.
This study's planned enrollment of 78 is above the median of 25 across 269 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Universidad de Especialidades Espiritu Santo is the lead sponsor of 10 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 (). Plaque index \< 20% and absence of active periodontal infection. Ability and willingness to attend scheduled follow-up visits (up to 12 months). Written provided prior to any study-related procedure.
Exclusion Criteria:
Uncontrolled systemic diseases affecting bone healing (e.g., uncontrolled diabetes mellitus, 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 , anticoagulants).
Active periodontal disease or untreated oral infection. History of chemotherapy or radiotherapy to the head and neck region.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thin cortical bone plates harvested from the mandibular ramus will be fixed to the recipient ridge with titanium microscrews to form a cortical shell. The internal space will be filled with a 1:1 mixture of autogenous bone chips and xenogeneic particulate graft. This conventional technique represents the control group for comparison with xenogeneic and allogeneic materials.
Procedure: Cortical Shell Bone Grafting
Prefabricated bovine cortical laminae will be rehydrated, trimmed to contour, and fixed with titanium microscrews to the mandibular ridge. The enclosed space will be filled with a 1:1 mixture of autogenous bone chips and xenogeneic particulate graft to promote bone regeneration.
Procedure: Cortical Shell Bone Grafting
A allogenic cortical sheets be rehydrated, adapted to the defect site, and fixed with titanium microscrews. The internal space will be filled with a 1:1 mixture of autogenous bone chips and xenogeneic particulate graft, following the same standardized protocol as the other groups.
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).
Also known as: Shell technique, 3D Onlay bone graft
Horizontal Bone Gain (mm) Measured by CBCT
Participant-level horizontal bone gain at 6 months after surgery, measured on cone-beam computed tomography (CBCT) scans using standardized reference points. When two eligible posterior mandibular sites are treated in the same participant, the participant-level mean will be used for the primary analysis.
Time frame: 6 after surgery
Surgical Duration (minutes)
Total surgical time for each bone augmentation procedure, measured from the first anesthetic injection to the final suture. Timing will be recorded using a standardized chronometer to compare operative efficiency across autogenous, xenogeneic, and allogeneic cortical shell techniques.
Time frame: Day 0 (intraoperative measurement)
Relative Radiographic Density Using CBCT Gray Value Units
Relative radiographic density within the grafted area will be assessed using device-specific CBCT gray value measurements under standardized acquisition parameters. These values will not be interpreted as calibrated Hounsfield Units. Measurements will be performed by calibrated examiners.
Time frame: 3, 6, and 12 months after surgery
Postoperative Inflammation (mm Facial Measurement)
Postoperative swelling will be assessed by measuring the linear distance from the lip commissure to the tragus with a flexible tape. Measurements will be taken bilaterally under standardized conditions by the same examiner to evaluate differences among groups.
Time frame: Preoperative, immediate postoperative, days 3, 7, and 14
Volumetric Bone Gain (mm³)
Three-dimensional volumetric changes of the augmented area will be calculated by superimposing pre- and postoperative CBCT-derived meshes using surface registration software. The difference in total reconstructed volume (ΔVolume) will quantify the amount of new bone formation across techniques.
Time frame: 3, 6, and 12 months after surgery
Morphometric Surface Deviation (mm)
Surface deviation between pre- and postoperative 3D models will be analyzed using color-coded distance maps and point-to-surface metrics (mean absolute distance, RMS error, and 95th-percentile distance). This quantifies contour stability and remodeling patterns for each graft material.
Time frame: 3, 6, and 12 months after surgery
Secondary Horizontal Bone Gain at 3 and 12 Months
Horizontal bone gain measured on CBCT scans at 3 and 12 months after surgery will be analyzed as a secondary longitudinal outcome.
Time frame: 3 and 12 months after surgery
Plan to share: Yes — Yes, De-identified participant data and analysis code will be available upon reasonable request to the corresponding author after publication, following UEES data-sharing policies.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: De-identified individual participant data (IPD) and supporting documents will be available beginning 6 months after publication of the main results and will remain accessible for 5 years thereafter through the institutional repository of Universidad de Especialidades Espíritu Santo (UEES).
Access criteria: Qualified researchers may request access to the anonymized dataset, protocol, statistical analysis plan, informed consent form, and analytic code by contacting the corresponding author at alanataf@uees.edu.ec. Requests will be reviewed by the study team and the UEES Ethics Committee to ensure compliance with ethical and privacy regulations. Approved users will receive controlled access to the data for non-commercial research purposes only.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Nov 2026, 3 months later.
Of 167 non-industry interventional studies with no phase under Alveolar Bone Loss, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 3 months is below that.
Counting every sponsor, half of 167 studies reached it within 18 months; a quarter within 11 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Universidad de Especialidades Espiritu Santo