Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06661447

Bone Augmentation Techniques in the Mandible Posterior Region

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Bone Substitutes Alveolar Bone Grafting Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Espíritu Santo

Samborondón, Guayas, 092301, Ecuador

Location contact

Antonio Gabriel Lanata-Flores, Phd

CONTACT

[email protected]

+593(04)5000950

Antonio Lanata-Flores, Phd

PRINCIPAL_INVESTIGATOR

Estefania Ayala, Phd

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Shell technique, 3D Onlay bone graft

Primary outcomes

  1. 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.

Secondary outcomes

  1. Surgical Duration (minutes)

    Time frame: Day 0 (intraoperative measurement)

    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.

  2. Relative Radiographic Density Using CBCT Gray Value Units

    Time frame: 3, 6, and 12 months after surgery

    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.

  3. Postoperative Inflammation (mm Facial Measurement)

    Time frame: Preoperative, immediate postoperative, days 3, 7, and 14

    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.

  4. Volumetric Bone Gain (mm³)

    Time frame: 3, 6, and 12 months after surgery

    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.

  5. Morphometric Surface Deviation (mm)

    Time frame: 3, 6, and 12 months after surgery

    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.

  6. Secondary Horizontal Bone Gain at 3 and 12 Months

    Time frame: 3 and 12 months after surgery

    Horizontal bone gain measured on CBCT scans at 3 and 12 months after surgery will be analyzed as a secondary longitudinal outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio G Lanata-Flores

CONTACT

[email protected]

+593983820084

Sponsors and collaborators

Lead sponsor

Universidad de Especialidades Espiritu Santo

Other

Registry information

Official study title

Comparison of Bone Augmentation Techniques in the Mandibular Posterior Region: A Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Oct 28, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.