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Modified Shell Technique Versus Onlay Bone Graft in Anterior Maxilla

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03663439
Recruitment Status : Unknown
Verified September 2018 by Amr hisham mohamed, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Information provided by (Responsible Party):
Amr hisham mohamed, Cairo University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Implant Complication Procedure: modified shell technique Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: control group (modified shell technique) study group (onlay bone graft)
Masking: Single (Outcomes Assessor)
Masking Description: control group (modified shell technique) study group (onlay bone graft)
Primary Purpose: Treatment
Official Title: Evaluation of Modified Shell Technique Versus Onlay Bone Graft for Reconstruction of Atrophic Anterior Maxilla
Estimated Study Start Date : September 16, 2018
Estimated Primary Completion Date : September 20, 2018
Estimated Study Completion Date : February 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

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

Primary Outcome Measures :
  1. Histomorphometric [ Time Frame: 3 months ]
    Type of bone formed by graft, after 3 months biopsy from the bone formed

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Responsible Party: Amr hisham mohamed, Dentist, Cairo University Identifier: NCT03663439    
Other Study ID Numbers: 1552016
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amr hisham mohamed, Cairo University:
anterior augmentation,shell technique,onlay bone graft