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Active, not recruitingNCT07210385RCTUpdated Oct 7, 2025

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

An interventional study of anterior horizontal maxillary bone augmentation using autogenous and bovine sticky bone and anterior horizontal maxillary bone augmentation using autogenous and bovine bone shell technique (khoury) in Maxillary Augmentation in Horizontal Bone Defect, sponsored by Cairo University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-10-07.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Maxillary Augmentation in Horizontal Bone Defect

Keywords

  • Horizontal Bone Defects , Maxillary augmentation , sticky bone , bone shell technique , dental implants, alveolar ridge augmentation
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Autogenous + Bovine Sticky Bone

    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, prepared as Sticky Bone in the area of the defect

    Procedure: anterior horizontal maxillary bone augmentation using autogenous and bovine sticky bone

  • Active comparator
    Autogenous + Bovine Bone Shell Technique (Khoury)

    Participants in this group will undergo horizontal ridge augmentation using autogenous cortical bone plates harvested from the mandibular ramus fixed to the recipient site, with S1 Bovine Bone Graft used to fill the gap between plates and the alveolar bone.

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

Interventions

  • Procedureanterior horizontal maxillary bone augmentation using autogenous and bovine sticky bone

    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.

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

    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.

06

What researchers measure

Primary outcomes

  1. Anterior Horizontal Maxillary Alveolar ridge bone gain

    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.

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

Secondary outcomes

  1. Quality of bone formation

    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.

    Time frame: Up to 6 months

07

Study locations

1 site
  • Cairo University
    Al Manyal, Giza Governorate 12613, Egypt
08

References and documents

Publications

  • Shaker AE, Salem AS, El-Farag SA, Abdel-Rahman FH, El-Kenawy MH. Comparison of Khoury's Bone Shell Technique vs Titanium-reinforced Polytetrafluoroethylene Membrane for 3D-bone Augmentation in Atrophic Posterior Mandible: A Randomized Clinical Trial. J Contemp Dent Pract. 2024 Jun 1;25(6):518-526. doi: 10.5005/jp-journals-10024-3704. PubMed 39364817 ↗
  • Tony JB, Parthasarathy H, Tadepalli A, Ponnaiyan D, Alamoudi A, Kamil MA, Alzahrani KJ, Alsharif KF, Halawani IF, Alnfiai MM, Ramachandran L, Balaji TM, Patil S. CBCT Evaluation of Sticky Bone in Horizontal Ridge Augmentation with and without Collagen Membrane-A Randomized Parallel Arm Clinical Trial. J Funct Biomater. 2022 Oct 19;13(4):194. doi: 10.3390/jfb13040194. PubMed 36278663 ↗
  • Yazhini P K, Suresh N, Kaarthikeyan G. Subperiosteal Ridge Augmentation Technique Utilizing Sticky Bone: A Case Series. Cureus. 2024 Jul 29;16(7):e65641. doi: 10.7759/cureus.65641. eCollection 2024 Jul. PubMed 39205712 ↗
  • Barbu HM, Iancu SA, Rapani A, Stacchi C. Guided Bone Regeneration with Concentrated Growth Factor Enriched Bone Graft Matrix (Sticky Bone) vs. Bone-Shell Technique in Horizontal Ridge Augmentation: A Retrospective Study. J Clin Med. 2021 Aug 31;10(17):3953. doi: 10.3390/jcm10173953. PubMed 34501399 ↗
  • De Angelis P, Cavalcanti C, Manicone PF, Liguori MG, Rella E, De Rosa G, Palmieri A, D'Addona A. A Comparison of Guided Bone Regeneration vs. the Shell Technique Using Xenogeneic Bone Blocks in Horizontal Bone Defects: A Randomized Clinical Trial. Dent J (Basel). 2024 May 9;12(5):137. doi: 10.3390/dj12050137. PubMed 38786535 ↗

Individual participant data

Plan to share: Undecided — The decision to share individual participant data (IPD) has not yet been made. Data sharing will depend on institutional review board (IRB) approvals, institutional policies, and participant consent. If data sharing is approved in the future, detailed information about the process, access conditions, and timelines will be provided.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07210385
Lead sponsor
Cairo University
Responsible party
Seham Mohammed Ahmed Ahmed Salama (Faculty of Oral & Dental Medicine , Cairo University, Cairo University) — Principal investigator
First posted
Oct 7, 2025
Start date
Jul 30, 2025
Primary completion
Jan 28, 2026 (estimated)
Completion
Feb 28, 2026 (estimated)
Last update
Oct 7, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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