Bone Augmentation Techniques in the Mandible Posterior Region

NCT06661447 | Not Yet Recruiting

• 1 other identifier: 2024-ODONT-002
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Alveolar Bone Atrophy; Bone Substitutes; Bone Resorption

Outcome Measures

Primary Outcomes (1)

• Horizontal Bone Gain (mm) Measured by CBCT

  Linear horizontal bone gain at the grafted posterior mandibular ridge, measured on cone-beam computed tomography (CBCT) scans using standardized reference points. Measurements will be performed at 3, 6, and 12 months post-surgery by two calibrated, blinded examiners. Mean values per site will be compared among the three groups (autogenous, xenogeneic, allogeneic).

  3, 6, and 12 months after surgery

Secondary Outcomes (5)

• Surgical Duration (minutes)

  Day 0 (intraoperative measurement)

• Bone Density (Hounsfield Units) on CBCT

  3, 6, and 12 months after surgery

• Postoperative Inflammation (mm Facial Measurement)

  Preoperative, immediate postoperative, days 3, 7, and 14

• Volumetric Bone Gain (mm³)

  3, 6, and 12 months after surgery

• Morphometric Surface Deviation (mm)

  3, 6, and 12 months after surgery

Study Arms (3)

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.

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.

Procedure: Cortical Shell Bone Grafting

Allogenic Onlay bone graft

EXPERIMENTAL

A allogenic onlay cortical sheets will be 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

Interventions

Cortical Shell Bone Grafting PROCEDURE

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

Allogenic Onlay bone graft; Autogenous Cortical Shell Graft; Xenogeneic Cortical Shell Graft

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Especialidades Espiritu Santo: lead

Study Sites (1)

Universidad Espíritu Santo

Samborondón, Guayas, 092301, Ecuador

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Antonio G Lanata-Flores

CONTACT

+593983820084; alanataf@uees.edu.ec

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label surgical trial. Due to the nature of the interventions, participants, surgeons, and investigators cannot be blinded. The statistician responsible for the primary analysis will remain blinded to group allocation until completion of the primary analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: October 28, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

EC (1)