NCT05286541

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 10, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

February 18, 2022

Last Update Submit

November 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Bone area percent

    Six months after the operation

Study Arms (2)

Lateralized buccal cortex group with xenograft

EXPERIMENTAL

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

lateralized buccal cortex with autogenous particulate

ACTIVE COMPARATOR

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

Interventions

the buccal cortex of the deficient ridge was separated and lateralized then fixed at the desired distance

Lateralized buccal cortex group with xenograft

lateralized buccal cortex with autogenous particulate

lateralized buccal cortex with autogenous particulate

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • Atef M, Shawky M, Mounir M, Gibaly A. Assessment of Modified Ridge Split With Autogenous Versus Xenogenic Augmentation: Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Jun;27(3):e70046. doi: 10.1111/cid.70046.

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Mohammed Atef, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 18, 2022

Study Start

October 10, 2023

Primary Completion

October 20, 2024

Study Completion

October 20, 2024

Last Updated

December 3, 2024

Record last verified: 2024-11

Locations