Comparative Study Between Custom-made Polyether Ether Ketone and Titanium Mesh for Augmentation of Atrophic Posterior Mandible. Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Vertical amount of bone increased (length in millimeters). horizontal amount f bone increased after augmentation (width in millimeters).
Study Overview
Brief Summary
Comparative study between custom-made polyether ether ketone and titanium mesh for augmentation of atrophic posterior mandible.
Detailed Description
Designing and manufacturing
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The CBCT images of the patient will be used to build a digital model using a 3D planning software (Mimics innovation suite). Based on this model, a machine will be used to mill a pressed and pre-sintered body of PEEK to the desired macroscopic shape.
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The size of the machined sheet is enlarged in order to compensate for the sintering shrinkage performed at 1450 C.
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After manufacturing, the sheet will be cleaned in an ultrasonic bath of 70% alcohol for 15 min, followed by a brief heating to 1200 C.
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It will be again cleaned in an ultrasonic bath for 3x15 min using 90% alcohol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with atrophic posterior mandible
- •No intraoral soft and hard tissue pathology
- •No systemic condition that contraindicate implant placement
Exclusion Criteria
- •Untreated gingivitis, periodontitis
- •Insufficient oral hygiene
- •Previous radiation therapy the head and neck neoplasia, or bone augmentation to implant site.
- •Systemic disorders
- •Heavy smoking more than 20 cigarettes per day
- •Bone pathology
- •Psychiatric problems
- •Emotional instability
- •Unrealistic aesthetic demands
Arms & Interventions
Custom Made Poly Ether Ether Ketone Mesh
Applying Poly Ether Ether Ketone mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation
Intervention: under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh (Procedure)
Conventional Titanium mesh
Applying Titanium mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation
Intervention: under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh (Procedure)
Outcomes
Primary Outcomes
Vertical amount of bone increased (length in millimeters). horizontal amount f bone increased after augmentation (width in millimeters).
Time Frame: 6 months
Length (Vertical Augmentation) Width (horizontal augmentation) gained after augmentation of atrophic mandible in millimeters using cone beam computed tomography (measuring tool) measurment tools : with the aid of cone beam computed tomography
Secondary Outcomes
- Rate of Soft Tissue Dehiscence(6 months)
Investigators
Adham Zakaria
Master Degree Candidate.
Cairo University