The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible
Primary Purpose
Edentulous Patients, Atrophic Posterior Mandible With Insufficient Width
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computer Guided ridge splitting in posterior mandible
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Patients
Eligibility Criteria
Inclusion Criteria:
- Patients with edentulous posterior area of the mandible insufficient width less than 5m, Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement.
Exclusion Criteria:
- 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.
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Computer Guided ridge splitting in posterior mandible
Arm Description
fabrication of a computer aided surgical guide and performing ridge splitting in posterior mandible using piezosurgery
Outcomes
Primary Outcome Measures
Time of the procedure ,pain and edema
the time of the procedure will be measured numerical using visual analogue scan
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03748615
Brief Title
The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible
Official Title
The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2018 (Anticipated)
Primary Completion Date
September 20, 2019 (Anticipated)
Study Completion Date
November 20, 2019 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The use of implants has significantly increased prosthetic options for edentulous patient. However, implant placement in the Posterior mandibular region is often hampered significantly by insufficient atrophic width limitations
Detailed Description
Ridge splitting technique causes lateral ridge expansion which creates new implant bed by longitudinal osteotomy, positioning buccal cortex laterally. The buccal cortex is positioned laterally to create space between buccal and lingual cortical plates, which is filled by an endosseous implant with or without any graft material limitations.
Ridge split technique is a very predictable procedure that can achieve substantial gains in horizontal ridge width of the edentulous posterior mandible without associated morbidity. This technique allows the clinician to augment the site and do the implant insertion in a single stage surgery, shortening the healing period drastically.
In the conventional ridge splitting technique, a complete flap is raised to allow adequate visibility of the bone defect which can result in disturbance of vascular supply and increase bone resorption rates. In this case report, a new innovative computer guided closed alveolar ridge splitting flapless technique has been advocated to avoid this disruption.
As Guided implant placement showed a statistically superior accuracy when they are compared with freehand placement after guided osteotomy Computer guided ridge splitting may have a superior accuracy than the freehand ridge splitting and may reduce the time of surgery, healing period and post-operative pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Patients, Atrophic Posterior Mandible With Insufficient Width
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Computer Guided ridge splitting in posterior mandible
Arm Type
Experimental
Arm Description
fabrication of a computer aided surgical guide and performing ridge splitting in posterior mandible using piezosurgery
Intervention Type
Device
Intervention Name(s)
Computer Guided ridge splitting in posterior mandible
Intervention Description
The computer guided ridge splitting for patients with atrophic posterior mandible and with residual bone width at least 3 to 5mm of residual ridge.
The selected patients will be informed of the nature of the research work and informed consent will be signed.
Radiographic examination included preoperative digital panoramic radiograph with 1:1 magnification for each patient as a primary survey to obtain an approximation of the available bone height and detect the presence of remaining roots and localized pathosis.
Computer surgical guides are fabricated for partially edentulous patients using teeth and tissue as support for the guide.
The same surgeon performed all surgeries. All surgical procedures were performed under strict aseptic conditions, all patients received nerve block local anesthesia (Articaine 4% 1:100 000 epinephrine).
A crestal incision is made using No. 15 blade extending over the posterior mandible using computer guided surgical stent.
no flap elevation .
Primary Outcome Measure Information:
Title
Time of the procedure ,pain and edema
Description
the time of the procedure will be measured numerical using visual analogue scan
Time Frame
4 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with edentulous posterior area of the mandible insufficient width less than 5m, Both sexes.
No intraoral soft and hard tissue pathology
No systemic condition that contraindicate implant placement.
Exclusion Criteria:
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.
Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wallaa farahat mohamed, bds
Phone
01069543488
Email
loulu_90_ooo@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed khashaba, phd
Phone
01227754765
Email
mohammedkhashaba@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible
We'll reach out to this number within 24 hrs