Cortical Bone Plate Versus Cortico-cancellous Block Graft

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04567966

Collaborator

(none)

Enrollment

Location

Arms

18.2

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Horizontal Atrophy of Edentulous Alveolar Ridge	Procedure: Split-block technique Procedure: Cortico-cancellous block graft	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 28, 2018

Actual Primary Completion Date :

Jan 6, 2020

Actual Study Completion Date :

Mar 3, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Evaluation of bone quality [4 months]
Histomorphometric analysis (Masson's Trichrome stain)

Secondary Outcome Measures

Horizontal ridge dimensional changes [4 months]
Measuring the linear horizontal changes using CBCT

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo	Abbassia	Egypt	11566

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mina Adel Rizk Botros, Assistant Researcher, National Research Centre, Egypt

ClinicalTrials.gov Identifier:

NCT04567966

Other Study ID Numbers:

PER 18-1D

First Posted:

Sep 29, 2020

Last Update Posted:

Sep 29, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mina Adel Rizk Botros, Assistant Researcher, National Research Centre, Egypt

Split-bone block technique

Cortical bone plate

Cortico-cancellous block graft

Additional relevant MeSH terms:

Atrophy

Study Results

No Results Posted as of Sep 29, 2020