Buccal Cortical Separation and Lateralization for Horizontal Ridge Augmentation

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05286541
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 58.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Horizontal Ridge Deficiency	Procedure: Lateralized buccal cortex with xenograft; Procedure: Lateralized buccal cortex with autogenous particulate	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Buccal Cortical Separation and Lateralization for Horizontal Ridge Augmentation: A Randomized Clinical Trial
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Jan 28, 2022
• Actual Study Completion Date: Jan 28, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in horizontal bone gain [six months after the operation]

   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

Secondary Outcome Measures

1. Bone area percent [Six months after the operation]

   histomorphometric analysis of core biopsies was done at the time of implant insertion to determine the bone area percent at the implant sites

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of dentistry, Cairo University	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Mohammed Atef, PhD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Shawky, assistant lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT05286541
• Other Study ID Numbers: OMFS 3-3-9
• First Posted: Mar 18, 2022
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 18, 2022