Bone SubstitutesNCT06661447
Bone Augmentation Techniques in the Mandible Posterior Region
A study testing Cortical Shell Bone Grafting in people with Bone Substitutes and Alveolar Bone Grafting, run by Universidad de Especialidades Espiritu Santo at 1 site in Ecuador.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Substitutes, Alveolar Bone Grafting
- What is being tested?
- Cortical Shell Bone Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Aug 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ecuador1 site
Universidad Espíritu Santo
Samborondón, Guayas, 092301
Antonio Gabriel Lanata-Flores, Phd, +593(04)5000950, alanataf@uees.edu.ec
Estefania Ayala, Phd, payalaa@uees.edu.ec
About this study
Official title: Comparison of Bone Augmentation Techniques in the Mandibular Posterior Region: A Randomized Clinical Trial
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.
- Conditions
- Bone Substitutes, Alveolar Bone Grafting
- Being tested
- Cortical Shell Bone Grafting
- Keywords
- Alveolar Bone Atrophy, Bone Substitutes, Bone Resorption
- Medical subject headings
- Alveolar Bone Loss, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortical Shell Bone GraftingProcedure or surgery
Also called Shell technique, 3D Onlay bone graft
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).
| Study group | Role | What they receive |
|---|---|---|
| Autogenous Cortical Shell Graft | Active comparator | 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. Receives: Procedure: Cortical Shell Bone Grafting |
| Xenogeneic Cortical Shell Graft | Experimental | 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. Receives: Procedure: Cortical Shell Bone Grafting |
| Allogenic Cortical Shell Graft | Experimental | 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. Receives: Procedure: Cortical Shell Bone Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 after surgery
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone SubstitutesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, statistician-blinded, parallel-group clinical trial will be conducted in 78 participants presenting with posterior mandibular bone atrophy. Participants will be allocated in a 1:1:1 ratio to receive autogenous, xenogeneic, or allogeneic cortical shell augmentation. Each participant will receive only one allocated intervention, and the unit of analysis for the primary endpoint will be the participant.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Especialidades Espiritu Santo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Lanata Flores, Universidad de Especialidades Espiritu Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661447
- Sponsor's protocol ID
- 2024-ODONT-002
- Status last verified
- Jul 2026
- First submitted
- 2 Sep 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bone Augmentation Techniques in the Mandibular Posterior Region: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06661447
- Acronym / sponsor ID
- 2024-ODONT-002
- Conditions
- Bone Substitutes, Alveolar Bone Grafting
- Keywords
- Alveolar Bone Atrophy, Bone Substitutes, Bone Resorption
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Universidad de Especialidades Espiritu SantoUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized, statistician-blinded, parallel-group clinical trial will be conducted in 78 participants presenting with posterior mandibular bone atrophy. Participants will be allocated in a 1:1:1 ratio to receive autogenous, xenogeneic, or allogeneic cortical shell augmentation. Each participant will receive only one allocated intervention, and the unit of analysis for the primary endpoint will be the participant.
| Arm | Type | Receives |
|---|---|---|
| Autogenous Cortical Shell Graft | Active comparator | Procedure: Cortical Shell Bone GraftingThin 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. |
| Xenogeneic Cortical Shell Graft | Experimental | Procedure: Cortical Shell Bone GraftingPrefabricated 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. |
| Allogenic Cortical Shell Graft | Experimental | Procedure: Cortical Shell Bone GraftingA 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cortical Shell Bone GraftingAlso: Shell technique, 3D Onlay bone graftSurgical 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). | Procedure or surgery | Allogenic Cortical Shell Graft, Autogenous Cortical Shell Graft, Xenogeneic Cortical Shell Graft |
Primary outcome
Horizontal Bone Gain (mm) Measured by CBCT
Time frame: 6 after surgery
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: 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.
Related trials for Bone Substitutes
Active, not recruiting
Evaluation of the Efficiency of the Bone Substitute Cerament-G Locally Delivering Gentamicin in the Treatment of Chronic Osteomyelitis of Long Bones
Osteomyelitis Chronic
Active, not recruitingObservational study
Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.
Bone Deformity
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruitingPhase 2/3
Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial
Spinal Cord Injury, Spinal Cord Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cortical Shell Bone Grafting in people with Bone Substitutes and Alveolar Bone Grafting, run by Universidad de Especialidades Espiritu Santo at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio G Lanata-Flores (+593983820084, alanataf@uees.edu.ec), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal Bone Gain (mm) Measured by CBCT (time frame: 6 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.