The Cortical Shield for Facial Bone Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-03

Study Completion Date

2021-04-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate a novel technique of bone regeneration and simultaneous implant placement in severely damaged sockets.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reconstruction of Deficient Atrophic Ridges Using Guide Bone Regeneration Technique

NCT06746935

Ridge Augmentation Bone Augmentation

RECRUITING NA

Reconstruction of Deficient Maxillary Ridges Using Retromolar Blocks With and Without Collagen Membrane

NCT06900933

Bone Augmentation

RECRUITING NA

Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

NCT00233922

Orbital Trauma Orbital Fractures

COMPLETED PHASE2

Clinical and Radiographic Assessment of a Novel Wedge Shape Implant Placed in Edentulous Narrow Ridges

NCT06178536

Surgical Technique Implant Surface

COMPLETED NA

Three-dimensional Bone Regeneration Using Custom-made Meshes With and Without Collagen Membrane

NCT04286334

Surgical Procedure, Unspecified Soft Tissue Infections Surgical Wound Dehiscence +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients requiring a single implant, presenting severe facial bone loss as a result of previous infection, failed socket grafting or trauma, will enter this cross-sectional study. Socket reconstruction and simultaneous implant placement will be performed through periosteal-guided bone regeneration (PGBR). Implant timing: immediate or delayed. Implants will be encased in a customized shield of autogenous cortical bone harvested from an adjacent site. A re-entry surgery will be performed at 12-17-weeks to evaluate bone regeneration. Peri-implant tissues will be assessed following established success criteria. Implants will be evaluated for the presence of Periimplantitis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tooth Loss Tooth Diseases Tooth Fracture Tooth Injuries Periodontal Bone Loss Periodontitis Peri-Implantitis Tooth Decay

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Immediate

implants are placed immediately after tooth extraction

No interventions assigned to this group

Delayed

implants are placed months after the tooth has been extracted

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ASA1 or ASA2 (American Society of Anesthesiologists)
* Healthy individuals with good oral hygiene and motivation
* No systemic uncontrolled diseases
* Not taking drugs known to modify bone metabolism

Exclusion Criteria

* Individuals with untreated \& generalized severe periodontitis
* Heavy smokers (\>10 cigarettes/day)
* Poor oral hygiene
* Diabetes (HbA1C \>6.5% as cutoff value)
* Uncontrolled cardiovascular disease
* Poor overall health (ASA IV)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes