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NCT Number: NCT07056920

Evaluation of Horizontal Bone Gain of Ridge Augmentation Using Customized Porous Zirconia Shell.

Khoury technique, which employs autogenous bone blocks harvested from the patient, has been widely used for horizontal and vertical ridge augmentation. This method introduces critical limitations, including the technical complexity, morbidity associated with donor site harvesting, such as infection, neurosensory disturbances, and post-operative discomfort

This clinical case series aims to demonstrate how customized pours zirconium shell could be an alternative technique for ridge augmentation to overcome the limitations of Khoury shell technique.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October University for modern sciences and arts (MSA University)

Giza, Giza Governorate, 12451, Egypt

Location status: Recruiting

Location contact

Ahmed Abd Elrahman, Professor

PRINCIPAL_INVESTIGATOR

Ahmed R. Abdel Elrahman, Professor

CONTACT

[email protected]

00201206960001

Ahmed Shawky, Bachelor

PRINCIPAL_INVESTIGATOR

Nada Zazou, Lecturer

CONTACT

[email protected]

00201224016945

Nada Zazou, Lecturer

PRINCIPAL_INVESTIGATOR

Rasha Attia, PhD

PRINCIPAL_INVESTIGATOR

About this study

Ridge augmentation is a surgical procedure designed to increase the height and width of the alveolar ridge to provide adequate bone volume for the placement of dental implants. Deficient alveolar ridges are treated using various surgical techniques to restore adequate bone volume for dental implant placement. These techniques include guided bone regeneration (GBR), ridge splitting, distraction osteogenesis, autogenous block bone grafting, onlay bone grafting, and maxillary sinus lifting.

The Khoury technique is a widely recognized approach in dental implantology for horizontal and vertical ridge augmentation. This technique involves the use of autogenous bone blocks harvested from the patient, typically from the mandibular symphysis or ramus. These bone blocks are split into thin laminae and stabilized with micro screws to reconstruct deficient alveolar ridges , and the voids created between the bone blocks are filled with autogenous bone chips to promote regeneration .

This approach is associated with risks, such as donor site morbidity, infection, and potential neurosensory disturbances, sever post operative pain, also technical complexity of the procedure also restricts its application to highly skilled clinicians and patients with adequate donor sites.

These challenges highlight the need for alternative techniques or improved strategies to overcome the limitations of the Khoury technique while achieving predictable outcomes in ridge augmentation procedures.

Zirconia is utilized in the fabrication of zirconia crowns and dental implants, among other dental replacement components. This material is a polycrystalline ceramic with high strength and rigidity, even at small thickness, and bio inertness, among other interesting properties.

The structural integrity of zirconium membranes makes them an excellent choice as non-resorbable membrane for GBR. Studies have demonstrated their excellent biocompatibility, optimal tissue integration, high mechanical strength that ensured effective space maintenance for bone formation, smooth surface that minimized soft tissue ingrowth. Additionally, zirconia's customizable nature allows for precise defect contouring, leading to improved aesthetic outcomes. Overall, zirconia membranes present a valuable tool in GBR procedures, offering potential advantages over traditional materials like titanium meshes .

All those studies used the zirconia as an occlusive 3D non-resorbable membrane except on animal study evaluated the effect of the porous zirconia membrane in comparison to the occlusive one .

In an attempt to overcome the limitation of Khoury technique, zirconia can be used as a shell to augment the deficient alveolar ridges. Hence the purpose of this clinical case series is to introduce a novel customized pours zirconium shell and to tomographically assess the bone gain after horizontal ridge augmentation for deficient mandibular ridges.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age more than 18 years old.
  • Deficient lower posterior area (Seibert class I).
  • Enough inter-arch space for placement of implant-supported prosthesis.
  • Motivated the patient to have the treatment.
  • Good oral hygiene.

Exclusion criteria

  • Patient with systematic conditions that could interfere with healing process.
  • Pregnant females
  • Smokers.
  • Poor oral hygiene.

Treatment and study plan

Zirconia shell technique

Procedure

Customized Zirconia membrane will be printed as a porous shell and will be used as a non resorbable membrane for horizontal ridge augmentation of deficient posterior mandibular region.

Primary outcomes

  1. Horizontal bone gain

    Time frame: 6 months postoperatively.

    Tomographic evaluation of the horizontal bone gain using CBCT in millimeters , CBCT scans will be performed to assess the amount of bone gain in comparison to the preoperative CBCT scans

Secondary outcomes

  1. Soft tissue dehiscence

    Time frame: Soft tissue will be evaluated post-operatively at 1, 2, 4, 6, 8, 12, and 16 week recall appointments

    Any Zirconia membrane exposure at the incision line during the healing period will be considered as soft tissue dehiscence. It will evaluated by:

    • Clinical inspection: Yes or No
    • any oft tissue dehiscence will be classified according to Fontana Classification (Fontana et al 2011) as:
    • Class I: Small membrane exposure (≤ 3 mm) without purulent exudate.
    • Class II: Large membrane exposure (> 3 mm) without purulent exudate.
    • Class III: Membrane exposure with purulent exudate.
    • Class IV: Abscess formation without membrane exposure.
  2. Swelling score

    Time frame: Swelling score will be evaluated for one week postoperatively

    Any Swelling at the surgical area will be evaluated using the Visual Analog Scale (VAS) (0 = no swelling, 4 = extensive swelling) for 1 week postoperatively.

    The participants will be instructed to record the presence of the swelling and its degree in swelling chart as follow:

    • No swelling
    • Slight (Intraoral swelling at surgical site that cannot be recognized by others)
    • Moderate (Intraoral swelling at surgical site that can be recognized by others)
    • Extensive (Extra-oral swelling that extends beyond surgical site)
  3. Pain score

    Time frame: First thing in the morning for the first 7 days post-operatively.

    Pain intensity will be evaluated using the Numerical Rating Scale (NRS) (0 = no pain, 10 = worst pain imaginable). Patients will record the pain score in the pain chart that will be collected at week 1 recall appointment.

Study contacts

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

Ahmed S Refaey, Bachelor

CONTACT

[email protected]

+201111989751

Nada Zazou, Lecturer

CONTACT

[email protected]

00201224016945

Sponsors and collaborators

Lead sponsor

Ahmed Shawky

Other

Registry information

Official study title

Tomographic Evaluation of The Dimensional Changes After Horizontal Ridge Augmentation of the Lower Posterior Mandible Using a Novel Customized Porous Zirconia Shell Technique: Clinical Case Study.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2025
Registry last updated
Jul 31, 2025

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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