Bone Augmentation Techniques in the Mandible Posterior Region
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversidad de Especialidades Espiritu Santo
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Cortical Shell Bone Grafting
Procedure/SurgerySurgical 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).
Treatment groups
78 Participants
are divided into 3 treatment groupsGroup A: Autogenous Cortical Shell GraftActive comparator 1 intervention
Group B: Xenogeneic Cortical Shell GraftExperimental treatment 1 intervention
Group C: Allogenic Cortical Shell GraftExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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)2
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 surgery3
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 144
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 surgerySponsors and contacts
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Source ClinicalTrials.gov
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