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Clinical Trials/NCT03680118
NCT03680118UnknownNot Applicable

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.

Cairo University0 sites24 target enrollmentStarted: December 15, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
24
Primary Endpoint
vertical bone gain

Study Overview

Brief Summary

Atrophic ridge augmentation utilizing guided bone regeneration (GBR) has become a major treatment option to provide optimal bone support for osseointegrated dental implants. GBR was initially employed to treat simple defects, including dehiscence and fenestration defects. In addition, GBR has been utilized for horizontal and vertical ridge augmentations and has demonstrated reproducible outcomes, with high implant survival rates and low complication rates. The results of recent clinical and histologic studies of ridge augmentation with GBR indicated that autogenous bone graft may be a suitable material for staged localized ridge augmentation in both horizontal and vertical augmentations. The main advantages of autogenous grafts are their osteogenic, osteoinductive and osteoconductive capabilities. Because of these qualities, autogenous grafts are considered by many to be the gold standard for bone regeneration

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 60 Years (Adult)
Sex
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.

Arms & Interventions

autogenous rings with GBR and autogenous graft with ti-mesh

Experimental

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

Intervention: autogenous rings with GBR and autogenous graft with ti-mesh (Device)

Outcomes

Primary Outcomes

vertical bone gain

Time Frame: 6 month

the amount of vertical bone gain will be measured using cone beam computed tomography

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mostafa Shawky Abd El-Moneim Shaheen

principal investigator

Cairo University

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