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NCT Number: NCT07841158

Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell

The goal of this clinical study is to learn whether a custom-made porous zirconia shell can support good-quality new bone when widening the lower back jaw before dental implant placement. The study includes adults whose jawbone in this area is too narrow for implants (Seibert Class I defects).

The main question it aims to answer is: What is the quality of the new bone formed under a porous zirconia shell, and how much inflammation does the tissue show?

Participants will:

* Receive gum treatment and a CBCT scan before surgery * Have bone augmentation surgery, in which a digitally designed porous zirconia shell is fixed over a mixture of their own bone and bovine bone graft * Return after 2 weeks for suture removal and a check of the wound * Return after 6 months for a CBCT scan, removal of the shell, collection of a small bone sample (biopsy), and dental implant placement

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October University for Modern Sciences and Arts (MSA), Faculty of Dentistry

Giza, Giza Governorate, Egypt

Location status: Recruiting

About this study

Horizontal bone loss in the posterior mandible often prevents dental implant placement. The Khoury technique uses thin autogenous cortical bone plates to rebuild the ridge, but harvesting these plates causes donor-site morbidity, is technically demanding, and is limited by available bone. Zirconia is biocompatible, mechanically strong and osteoconductive, and has shown low inflammatory response. However, it has not been studied as a shell replacing autogenous bone plates.

In this single-arm study, 10 adults with Seibert Class I defects in the posterior mandible will first receive non-surgical periodontal therapy. Compliance will be checked after 1 month. A zirconia shell with 1.5 mm pores will be digitally designed from each patient's CBCT scan, milled on a 5-axis machine, then cleaned and sterilized.

Under local anesthesia, buccal and lingual full-thickness flaps will be raised and the recipient bone decorticated. Autogenous bone chips will be harvested from the mandibular body with a bone chip maker and mixed 1:1 with xenograft. The shell will be fixed over the graft with 3-4 buccal screws. The flaps will be advanced and closed with a double-layer suture.

After 6 months, the shell will be removed, a core biopsy will be taken, and an implant will be placed. The biopsies will be fixed in 10% formalin and analyzed histologically, histomorphometrically and for tissue inflammatory response.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults older than 21 years
  • Horizontal bone defect (Seibert Class I) in the posterior mandible
  • Enough inter-arch space for an implant-supported prosthesis
  • Motivated to receive the treatment
  • Good oral hygiene

Exclusion criteria

  • Systemic conditions that could interfere with healing
  • Pregnancy
  • Smoking
  • Poor oral hygiene

Treatment and study plan

Customized porous zirconia shell

Device

A CAD/CAM-milled zirconia shell with 1.5 mm pores, designed from each patient's CBCT scan and fixed with 3-4 buccal screws over a 1:1 mix of autogenous bone chips and xenograft. It replaces the autogenous cortical plates used in the Khoury technique and is removed after 6 months.

Primary outcomes

  1. Quality of Newly Formed Bone Assessed by Descriptive Histological Analysis of the Core Biopsy

    Time frame: 6 months after ridge augmentation (at shell removal and implant placement)

    Qualitative histological assessment of the core bone biopsy harvested from the augmented site. Biopsies will be fixed in 10% formalin, processed and examined under light microscopy. The tissue structure of the augmented site will be described (Dellavia et al., 2021). Results will be reported as the number of participants whose biopsy shows newly formed bone in continuity with the native bone.

Secondary outcomes

  1. Percentage of newly formed bone

    Time frame: 6 months after augmentation

    Histomorphometric measurement of the new bone area as a percentage of the total biopsy area.

  2. Percentage of residual graft material

    Time frame: 6 months after augmentation

    Histomorphometric measurement of the remaining graft particle area as a percentage of the total biopsy area.

  3. Percentage of soft tissue

    Time frame: 6 months after augmentation

    Histomorphometric measurement of the non-mineralized connective tissue area as a percentage of the total biopsy area.

  4. Inflammatory cell infiltration score

    Time frame: 6 months after augmentation

    Semi-quantitative tissue response score from 0 (no inflammatory cells) to 4 (severe cellular infiltrate or tissue necrosis), based on the presence of lymphocytes, macrophages, foreign body giant cells, eosinophils and neutrophils.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Mohammed Mahmoud Abed

Other

Registry information

Official study title

Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue 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
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 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.

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