Vertical Ridge Augmentation With Autogenous Onlay Blocks Combined With Guided Bone Regeneration Versus Autogenous Bone Graft With Titanium Mesh in Posterior Mandible
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ClinicalTrials.gov Identifier: NCT03680118 |
Recruitment Status :
Not yet recruiting
First Posted : September 21, 2018
Last Update Posted : November 21, 2018
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Condition or disease | Intervention/treatment | Phase |
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Posterior Mandible With Deficient Ridge Height | Device: autogenous rings with GBR and autogenous graft with ti-mesh | Not Applicable |
The GBR Procedure requires to place a barrier between the bone graft and the surrounding soft tissues. This blocks the fast-duplicating connective and epithelial cells from colonizing the regenerating site.
Collagen membranes have been successfully used as a barrier membrane in clinical practice.
They have the advantage of being resorbable and pose less post-operative complications. On the other hand, collagen membranes are not rigid, causing a difficulty in maintaining the vertical height of the particulate bone graft placed onto the ridge.
Alternatively, titanium meshes have been used with success in clinical practice and display both advantages and disadvantages. They provide tenting effect thanks to their rigidity and, being moldable, can be easily given the shape needed to cover the defect.
However they must be removed, not resorbable, require time-consuming shaping and pose complications as flap dehiscence.
Choice of the comparator:
Current studies have shown that using titanium mesh as a barrier to protect the bone graft during GBR can be considered successful in terms of vertical bone gain.
There might be variable in other findings which could be attributed to differences in the methodology, such as using other membranes over the titanium mesh (collagen or PTFE membranes).
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Vertical Ridge Augmentation Using Autogenous Onlay Ring Blocks Combined With Guided Bone Regeneration Using Collagen Membrane Versus Autogenous Bone Graft Only Using Titanium Mesh in Atrophic Posterior Mandibles. |
Estimated Study Start Date : | December 15, 2018 |
Estimated Primary Completion Date : | November 2019 |
Estimated Study Completion Date : | December 2019 |
Arm | Intervention/treatment |
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Experimental: autogenous rings with GBR and autogenous graft with ti-mesh
Augmentation with autogenous onlay ring blocks covered by guided bone regeneration (GBR) using collagen membrane and autogenous bone graft using titanium mesh (ti-mesh) only
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Device: autogenous rings with GBR and autogenous graft with ti-mesh
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- vertical bone gain [ Time Frame: 6 month ]the amount of vertical bone gain will be measured using cone beam computed tomography

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Ages Eligible for Study: | 25 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients with edentulous posterior mandible.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
- Residual alveolar bone height more than 6 mm (7-9 mm) and less than 12 mm.
Exclusion Criteria:
- Presence of fenestrations or dehiscence of the residual ridge.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680118
Contact: Mostafa Shawky Shaheen, BDS | +201118153852 | dentshaheen@gmail.com | |
Contact: Mohamed Atef, PhD | +201009612708 | zokasur@gmail.com |
Responsible Party: | Mostafa Shawky Abd El-Moneim Shaheen, principal investigator, Cairo University |
ClinicalTrials.gov Identifier: | NCT03680118 History of Changes |
Other Study ID Numbers: |
cairouimplant masters |
First Posted: | September 21, 2018 Key Record Dates |
Last Update Posted: | November 21, 2018 |
Last Verified: | November 2018 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |