Buccal Cortical Separation and Lateralization for Horizontal Ridge Augmentation

Qualitative and Quantitative Assessment of Autogenous Versus Xenogenic Horizontal Ridge Augmentation After Mandibular Ridge-split with Buccal Cortical Lateralization: a Randomizedcontrolled Trial

Cases with horizontal ridge deficiency less than what is possible for ridge splitting were recruited and the buccal cortex was totally separated and lateralized at the desired distance for augmentation

Study Overview

• Status: Completed
• Conditions: Horizontal Ridge Deficiency
• Intervention / Treatment: Procedure: Lateralized buccal cortex with xenograft; Procedure: Lateralized buccal cortex with autogenous particulate

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

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• suffering only from posterior mandibular horizontal ridge deficiency and with adequate inter-arch space to accommodate the future restoration

Exclusion Criteria:

• Heavy smokers, diabetics, patients with bleeding problems, liver and kidney diseases, bone diseases that can affect bone healing, previous history of any ridge augmentation procedure in the posterior mandible, and those undergoing or planned for radiotherapy or chemotherapy

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: Lateralized buccal cortex group with xenograft; the buccal cortical bone was osteotomized and separated to be fixed in a lateralized position at the desired distance and the gap filled with Xenograft	Procedure: Lateralized buccal cortex with xenograft; the buccal cortex of the deficient ridge was separated and lateralized then fixed at the desired distance
Active Comparator: lateralized buccal cortex with autogenous particulate; the buccal cortex was lateralized same as in the interventional group but the gap filled with autogenous particulate	Procedure: Lateralized buccal cortex with autogenous particulate; lateralized buccal cortex with autogenous particulate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in horizontal bone gain	the net average bone gain (in millimeters) was calculated: by calculating the difference between the immediate post operative bone width measured on the Immediate CBCT and the six months bone width measured on the six months CBCT	six months after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone area percent	histomorphometric analysis of core biopsies was done at the time of implant insertion to determine the bone area percent at the implant sites	Six months after the operation

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mohammed Atef, PhD, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Actual): October 20, 2024
• Study Completion (Actual): October 20, 2024

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: OMFS 3-3-9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No