Augmentation of Atrophic Mandibule Using Poly Ether Ether Ketone Mesh (RCT)
Primary Purpose
Mandible Small
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
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
Sponsored by
About this trial
This is an interventional treatment trial for Mandible Small
Eligibility Criteria
Inclusion Criteria:
- Patients with atrophic posterior mandible
- Both sexes
- 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
Sites / Locations
- Faculty Of Dental and Oral Medicine-Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Custom Made Poly Ether Ether Ketone Mesh
Conventional Titanium mesh
Arm Description
Applying Poly Ether Ether Ketone mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation
Applying Titanium mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation
Outcomes
Primary Outcome Measures
Vertical amount of bone increased (length in millimeters). horizontal amount f bone increased after augmentation (width in millimeters).
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 Outcome Measures
Rate of Soft Tissue Dehiscence
which mesh will cause soft tissue dehiscence more.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04017117
Brief Title
Augmentation of Atrophic Mandibule Using Poly Ether Ether Ketone Mesh
Acronym
RCT
Official Title
Comparative Study Between Custom-made Polyether Ether Ketone and Titanium Mesh for Augmentation of Atrophic Posterior Mandible. Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
November 25, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comparative study between custom-made polyether ether ketone and titanium mesh for augmentation of atrophic posterior mandible.
Detailed Description
Designing and manufacturing
1. 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.
2. The size of the machined sheet is enlarged in order to compensate for the sintering shrinkage performed at 1450 C.
3. 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.
4. It will be again cleaned in an ultrasonic bath for 3x15 min using 90% alcohol.
5. Thereafter the sheet was placed in an autoclave and sterilized using a standard program.
6. The sheets will have a thickness of approximately 0.5 - 0.7 mm. b. Surgery
The intraoral area is initially cleaned with chlorhexidine 1 mg/ml.
Local anesthesia is administered.
Horizontal crestal incisions are made lingual of the mid-crest within the keratinized tissue. Vertical releasing incisions are placed on the buccal aspect of the surgical site in the usual manner to provide adequate access and to allow for eventual coronal repositioning.
Then, a full-thickness mucoperiosteal flap is reflected to completely expose the atrophic ridge.
The cortex of the mandibular crest is generously perforated to produce bleeding in multiple sites. The pilot holes for the fixation screws were also prepared at this time.
The barrier is inserted over the mandible and compressed into place, the fixation screws are inserted and no adaptation will be needed as the barrier is custom-made for the edentulous ridge.
The ceramic sheets is cleaned with 3% hydrogen peroxide prior to soft tissue closure.
After fixation of the sheets, the buccal flaps should be coronally repositioned.
Split-thickness periosteal releasing incisions are completed to aid in primary tension-free closure. The flap margins are then advanced over the barrier and approximated to evaluate for tension-free closure.
After a mean of 6 months of uneventful healing, the augmented sites are reopened. The ceramic barrier and fixation screws are identified and removed, followed by Dental implant.
Post-operative care:
Avoid traumatization of the surgical site. Patients must abstain from brushing at the surgical area. Instead, a disinfecting mouth rinse should be used (e.g. chlorhexidine 0.2%).
Instruct the patient not to touch or manipulate the surgical area. Ice packs for 10 minutes every 30 minutes for 24 hours. Do not use removable dentures during the expansion phase. Temporary fixed partial dentures must be adjusted to the expected tissue gain.
No consume of tobacco
Post-operative medications will be prescribed as follows:
Amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, diclofenac potassium 50mg every 8 hours for 4 days and then as needed, metronidazole 5 mg/kg every 8 hours for 7 days and chlorhexidine gluconate 0.1% mouthwash 3 times daily for 14 days.
11b. Criteria for discontinuing or modifying intervention: No protocol for discontinuation of the procedure. 11c. Strategies to improve adherence to intervention: Face to face adherence reminder session will take place to stress on the post-operative instructions at the following time intervals.
Patients were recalled every other day to monitor soft tissue healing for the first week, one visit weekly for the first month then monthly for 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandible Small
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Clinical Trial. A trial will be carried out in hospital of Oral and Maxillofacial surgery department,Faculty of Oral and Dental Medicine Cairo University Equal randomization parallel group study positive controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Custom Made Poly Ether Ether Ketone Mesh
Arm Type
Experimental
Arm Description
Applying Poly Ether Ether Ketone mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation
Arm Title
Conventional Titanium mesh
Arm Type
Active Comparator
Arm Description
Applying Titanium mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation
Intervention Type
Procedure
Intervention Name(s)
under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh
Intervention Description
comparing between PEEK mesh and Titanium mesh for augmentation of posterior atrophic mandible using mix of autogenous bone graft and bone substitute.
Primary Outcome Measure Information:
Title
Vertical amount of bone increased (length in millimeters). horizontal amount f bone increased after augmentation (width in millimeters).
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rate of Soft Tissue Dehiscence
Description
which mesh will cause soft tissue dehiscence more.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with atrophic posterior mandible
Both sexes
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adham Y Zakaria, Master
Phone
00201226000564
Email
amira_5queens@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adham Y Zakaria, Master
Phone
00201226000741
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed F Shehab, PHD
Organizational Affiliation
Professor of Oral and Maxillofacial Surgery - Cairo University.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Khaled A Salaheddin, PHD
Organizational Affiliation
Lecturer of Oral and Maxillofacial Surgery - Cairo University.
Official's Role
Study Director
Facility Information:
Facility Name
Faculty Of Dental and Oral Medicine-Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adham Y Zakaria, Master
Phone
00201226000564
Email
amira_5queens@hotmail.com
First Name & Middle Initial & Last Name & Degree
Adham Y Zakaria, Master
Phone
00201226000741
Email
amira_5queens@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22140660
Citation
Misch CM. Bone augmentation of the atrophic posterior mandible for dental implants using rhBMP-2 and titanium mesh: clinical technique and early results. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):581-9.
Results Reference
background
PubMed Identifier
22285340
Citation
Her S, Kang T, Fien MJ. Titanium mesh as an alternative to a membrane for ridge augmentation. J Oral Maxillofac Surg. 2012 Apr;70(4):803-10. doi: 10.1016/j.joms.2011.11.017. Epub 2012 Jan 28.
Results Reference
background
PubMed Identifier
18980518
Citation
Pieri F, Corinaldesi G, Fini M, Aldini NN, Giardino R, Marchetti C. Alveolar ridge augmentation with titanium mesh and a combination of autogenous bone and anorganic bovine bone: a 2-year prospective study. J Periodontol. 2008 Nov;79(11):2093-103. doi: 10.1902/jop.2008.080061.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/18980518
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/22140660
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/22285340
Description
Related Info
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Augmentation of Atrophic Mandibule Using Poly Ether Ether Ketone Mesh
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