Cortical Bone Plate Versus Cortico-cancellous Block Graft

Cortical Bone Plate Versus Cortico-cancellous Block Graft for Horizontal Ridge Augmentation: Histomorphometric and Cone Beam Computed Tomography Study

Horizontal ridge augmentation using either cortical bone plate technique or cortico-cancellous block graft was the aim of the study. Bone quality was analyzed histomorphomterically, and horizontal dimensional changes were assessed using CBCT.

Study Overview

• Status: Completed
• Conditions: Horizontal Atrophy of Edentulous Alveolar Ridge
• Intervention / Treatment: Procedure: Split-block technique; Procedure: Cortico-cancellous block graft

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 11566
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eligible patients aged 18 years or older with partial edentulism of the mandible
• The residual ridge width must be 4 mm or less
• Intra-oral donor sites should be available in the external oblique ridge and symphyseal area

Exclusion Criteria:

• Patients with general contraindications for implant surgery such as uncontrolled diabetes
• Irradiation of the head and neck region
• Intravenous bisphosphonate
• Pregnancy
• Smokers, alcoholics and drug abusers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cortical bone plate; A cortical plate was harvested from the external oblique ridge and split in half. Then one plate was fixed at a distance from the atrophied ridge and autogenous bone chips were used to fill the gap between the plate and the ridge.	Procedure: Split-block technique; Horizontal ridge augmentation using the split-block technique where a cortical bone plate harvested from the external oblique ridge was split in half and fixed at a distance from the atrophied ridge. Then autogenous bone chips were packed in the gap between the plate and the ridge.
Active Comparator: Cortico-cancellous block graft; A cortico-cancellous block graft was harvested from the symphysis of the mandible and fixed to the atrophied ridge.	Procedure: Cortico-cancellous block graft; Horizontal ridge augmentation using a cortico-cancellous block harvested from the chin of the mandible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of bone quality	Histomorphometric analysis (Masson's Trichrome stain)	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horizontal ridge dimensional changes	Measuring the linear horizontal changes using CBCT	4 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): January 6, 2020
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Split-bone block technique; Cortical bone plate; Cortico-cancellous block graft
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: PER 18-1D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No