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NCT Number: NCT07210385

Radiographic and Histomorphometric Assessment of Anterior Horizontal Maxillary Bone Augmentation Using Autogenous and Bovine Sticky Bone Versus Autogenous and Bovine Bone Shell Technique (Khoury): A Randomized Comparative Clinical Trial

This clinical trial aims to compare two bone augmentation techniques for patients with anterior horizontal maxillary bone defects:

Autogenous and Bovine Sticky Bone Technique using S1 Bovine Bone Graft Autogenous and Bovine Bone Shell Technique (Khoury Technique). The study will evaluate the amount of bone gain and the quality of bone formation after six months using radiographic (CBCT) and histomorphometric analysis. Patients will be randomly assigned to one of the two groups and followed for six months post-surgery to assess bone regeneration, surgical outcomes, and potential complications.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Maxillary Augmentation in Horizontal Bone Defect

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Al Manyal, Giza Governorate, 12613, Egypt

About this study

This randomized controlled clinical trial will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University. The study addresses the clinical challenge of horizontal maxillary bone defects, which complicate implant placement and require effective augmentation techniques.

Two techniques will be compared:

Autogenous and Bovine Sticky Bone: Using S1 Bovine Bone Graft mixed with autogenous bone chips in a 70:30 ratio.

Autogenous and Bovine Bone Shell Technique (Khoury): Using autogenous cortical bone shells harvested from the mandible combined with S1 Bovine Bone.

The primary outcome is horizontal bone gain assessed by CBCT immediately after surgery and at six months before implant placement. Secondary outcomes include histomorphometric analysis of bone core biopsies to evaluate the quality of bone regeneration.

Randomization will be performed with a 1:1 allocation ratio using computer-generated sequences. Patients will be blinded to the intervention, and follow-up will be conducted at 3 days, 1 week, 1 month, 2 months, and 6 months postoperatively.

The trial aims to determine whether the less invasive sticky bone technique can achieve comparable or superior bone regeneration outcomes compared to the traditional bone shell method while reducing donor site morbidity and surgical complexity

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18-55 years.
  • Both males and females.
  • Patients with horizontal bone deficiency in the anterior maxillary region (< 3 mm width) requiring augmentation prior to implant placement.
  • Adequate oral hygiene and commitment to follow-up visits.

Exclusion criteria

  • Patients with systemic diseases affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
  • Heavy smokers (>10 cigarettes/day).
  • Pregnant or lactating women.
  • Previous bone grafting procedures at the same site.
  • Patients on medications affecting bone metabolism (e.g., bisphosphonates).

Treatment and study plan

anterior horizontal maxillary bone augmentation using autogenous and bovine sticky bone

Procedure

Participants in this group will undergo maxillary horizontal ridge augmentation using a mixture of autogenous bone chips and S1 Bovine Bone Graft in a 70:30 ratio. The graft will be prepared as Sticky Bone and applied to the defect site for augmentation.

anterior horizontal maxillary bone augmentation using autogenous and bovine bone shell technique (khoury)

Procedure

Participants in this group will undergo maxillary horizontal ridge augmentation using the Khoury Bone Shell Technique, combining autogenous bone blocks and Bovine Bone Graft to reconstruct the alveolar ridge. The graft will be fixed and stabilized to provide a rigid shell for bone regeneration.

Primary outcomes

  1. Anterior Horizontal Maxillary Alveolar ridge bone gain

    Time frame: Baseline (immediately post-surgery) 6 months after augmentation

    The primary outcome measure will be the amount of horizontal bone gain at the augmented site measured in millimeters using Cone Beam Computed Tomography (CBCT). Measurements will be taken immediately after augmentation and at 6 months before implant placement.

Secondary outcomes

  1. Quality of bone formation

    Time frame: Up to 6 months

    Bone core biopsy will be obtained at the time of implant placement to assess the percentage of newly formed bone, residual graft material, and connective tissue using histomorphometric analysis.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: RCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Oct 7, 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.