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

NCT ID: NCT07210385

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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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

Conditions

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Maxillary Augmentation in Horizontal Bone Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

anterior horizontal maxillary bone augmentation using autogenous and bovine sticky bone

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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anterior 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.

Intervention Type PROCEDURE

anterior 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Seham Mohammed Ahmed Ahmed Salama

Faculty of Oral & Dental Medicine , Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Al Manyal, Giza Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 39364817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36278663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39205712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34501399 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38786535 (View on PubMed)

Other Identifiers

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self funded

Identifier Type: OTHER

Identifier Source: secondary_id

omfs 3-3-20

Identifier Type: -

Identifier Source: org_study_id

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