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OpenTrials
Completed

NCT Number: NCT04827693

The Cortical Shield for Facial Bone Reconstruction

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

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Key information

Conditions

Tooth Loss Alveolar Bone Loss Bone Diseases Bone Resorption Dental Caries Mouth Diseases Musculoskeletal Diseases Peri-Implantitis Periodontal Atrophy Periodontal Bone Loss Periodontal Diseases Periodontitis Stomatognathic Diseases Tooth Decay Tooth Demineralization Tooth Diseases Tooth Fracture Tooth Fractures Tooth Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fernando Verdugo, DDS, Corp

Los Angeles, California, 90077, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Primary outcomes

  1. Individuals presenting alveolar Facial Bone regeneration at re-entry

    Time frame: 1 year

    Bone regeneration of the dent-alveolar socket

Secondary outcomes

  1. Pink Esthetic Scores

    Time frame: 1 year

    Scores 1-10: the higher the score the better the esthetic outcome. Evaluates soft tissue esthetics around the regenerated bone & implant: mesial & distal papillae, curvature of facial mucosa, level of facial mucosa, root convexity/soft tissue color & texture

  2. Facial implant transparency

    Time frame: 1 year

    Presence of implant transparency at 1 year follow-up: Yes/No

  3. Band of Keratinized tissue

    Time frame: 1 year

    Evaluation of the presence of a band of keratinized tissue around the implant: > 2mm or < 2mm

  4. Implant crestal bone loss

    Time frame: 1 year

    Radiographic evaluation of peri-implant marginal crestal bone loss

Sponsors and collaborators

Lead sponsor

Verdugo, Fernando, DDS

Indiv

Registry information

Official study title

The Cortical Shield for Facial Bone Reconstruction of Severely Damaged Sockets With Simultaneous Implant Placement

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Apr 8, 2021

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.

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