Modified Shell Technique Versus Onlay Bone Graft in Anterior Maxilla

Evaluation of Modified Shell Technique Versus Onlay Bone Graft for Reconstruction of Atrophic Anterior Maxilla

Amount of bone volume and (width and height):

Will be measured using linear measurements from CBCT after 6 month from implant insertion.

Will be measured using Histometric analysis of bone area percent sampling from recipient site after 6 months.

Study Overview

• Status: Unknown
• Conditions: Implant Complication
• Intervention / Treatment: Procedure: modified shell technique

Detailed Description

Augmentation of insufficient bone volume can be brought about by different methods, including, particulate and block grafting materials, Guided Bone Regeneration with or without growth and differentiation factors, ridge splitting, expansion and distraction osteogenesis, either alone or in combination. These techniques may be used for horizontal/vertical ridge augmentation

Autograft is considered as the Gold Standard for bone transplantation and various studies have shown efficacy for it. It is osteogenic, osteoconductive and osteoinductive. Autografts can be derived from extra oral source (iliac crest, ribs) or intraoral source (chin, ramus). They can be used in block or particulate form. Corticocancellous block grafts are preferred because of enhanced revascularization of the cancellous portion, and mechanical support and rigidity of the cortical portion, which ensures optimal ridge augmentation.

Fouad Khoury presented a three-dimensional (3D) reconstruction technique for atrophic ridges and complicated vertical bone defects using mandibular bone block graft "the Gold standard". There are several possibilities for augmentation of bone volume depending on situation, indication and adequate diagnosis; the treatment options can be extended from minimally invasive procedures with locally harvested bone grafts in local anesthesia, to very sophisticated grafting techniques for 3D bone reconstruction with extra oral harvested bone grafts. Khoury reported that his ascending ramus grafts is almost 5 times more than chin grafts

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with atrophic anterior maxilla
• No intraoral soft and hard tissue pathology
• No systemic condition that contraindicate implant placement
• Both sexes.

Exclusion Criteria:

• Heavy smokers more than 20 cigarettes per day.
• Patients with systemic disease that may affect normal healing.
• Psychiatric problems
• Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

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: modified shell technique; block of bone from the mandibular ramus divided into two shells ,grafting one shell in the anterior maxilla to increase width	Procedure: modified shell technique; divided block of bone into two shells and grafting one shell in anterior maxilla
Active Comparator: onlay bone graft; grafting block of bone from the mandibular ramus in the atrophic anterior maxilla	Procedure: modified shell technique; divided block of bone into two shells and grafting one shell in anterior maxilla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histomorphometric	Type of bone formed by graft, after 3 months biopsy from the bone formed	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 16, 2018
• Primary Completion (Anticipated): September 20, 2018
• Study Completion (Anticipated): February 16, 2019

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: anterior augmentation,shell technique,onlay bone graft
• Other Study ID Numbers: 1552016

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