Horizontal Ridge Augmentation of the Mandible Autogenous Block Grafts

Horizontal Ridge Augmentation of the Mandible Using Interpositional Autogenous Block Grafts Versus Onlay Block Grafts; Randomized Controlled Clinical Trial

20 subjects presenting with horizontal mandibular ridge width less than 5 mm were selected and randomly divided two groups (10 in each group). the first group received interpositional block grafts (harvested from the chin and ramus) covered with Platelet-rich fibrin membrane. the second group received onlay block grafts (harvested from the chin and ramus) and covered with Platelet-rich fibrin membrane. the grafts are left for 4 months. the alveolar ridge width dimensions is then measured using radiographic analysis using cone-beam computed tomography scans

Study Overview

• Status: Unknown
• Conditions: Horizontal Ridge Deficiency; Block Graft
• Intervention / Treatment: Procedure: ridge split interpositional block graft; Procedure: decortication Onlay block graft

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of both sexes with a minimum vertical bone height above the inferior alveolar canal of 10mm in the edentulous region.

Patients should have ridge thickness less than 5mm measured 2mm from the alveolar crest Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.

Exclusion Criteria:

• Patients with any systemic disease that may affect normal bone healing. Patients with drug allergies, drug or alcohol abuse, periodontal diseases or poor oral hygiene

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: Interpositional block graft; ridge split interpositional block graft	Procedure: ridge split interpositional block graft
Active Comparator: Onlay block graft; decortication onlay block graft	Procedure: decortication Onlay block graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
alveolar ridge width gained	radiographic analysis following ridge augmentation using Cone beam computed tomography	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient morbidity following the surgical procedure	pain value on pain scale	14 days

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: cebc.cairou

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