- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07932418
Assessment of the Oblique Sandwich Osteotomy for Augmentation of Posterior Atrophic Mandible
Rehabilitation of the partially or totally edentulous mandible with implant supported prosthesis has become a common practice in the last few decades. Local conditions of the edentulous ridges may be unfavorable for dental implant placement, where sufficient bony support in both the horizontal and vertical dimensions is the foundation of any successful oral rehabilitation with dental implants.
Challenges include the resorpative changes of the alveolar ridge after tooth extractions and the hard tissue deficits due to chronic periodontal disease or congenitally missing teeth. Neoplasm, osteomyelitis, cysts or trauma can also compromise the situation. All these factors require the oral implantologist to create using regenerative techniques sufficient hard tissue support at the appropriate site before or during dental implant installation.
Multiple bone grafting materials and techniques have been used to reconstruct the partially dentate and edentulous posterior mandibular ridges with high rates of success, these techniques include block onlay grafting technique, guided bone regeneration using membranes or meshes and distraction osteogenesis. The selection of the optimal technique depends on various factors, including the degree of the defect, the grafted bone substitute available, the medical condition of the patient and also the skill and experience of the operator.
The aim of this study is to evaluate the alveolar bone volume by the CBCT after performing oblique sandwich osteotomy in conjunction with interpositional autogenous bone grafting in the atrophied posterior mandible.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rehabilitation of the partially or totally edentulous mandible with implant supported prosthesis has become a common practice in the last few decades. Local conditions of the edentulous ridges may be unfavorable for dental implant placement, where sufficient bony support in both the horizontal and vertical dimensions is the foundation of any successful oral rehabilitation with dental implants.
Challenges include the resorpative changes of the alveolar ridge after tooth extractions and the hard tissue deficits due to chronic periodontal disease or congenitally missing teeth. Neoplasm, osteomyelitis, cysts or trauma can also compromise the situation. All these factors require the oral implantologist to create using regenerative techniques sufficient hard tissue support at the appropriate site before or during dental implant installation.
Multiple bone grafting materials and techniques have been used to reconstruct the partially dentate and edentulous posterior mandibular ridges with high rates of success, these techniques include block onlay grafting technique, guided bone regeneration using membranes or meshes and distraction osteogenesis. The selection of the optimal technique depends on various factors, including the degree of the defect, the grafted bone substitute available, the medical condition of the patient and also the skill and experience of the operator.
The aim of this study is to evaluate the alveolar bone volume by the CBCT after performing oblique sandwich osteotomy in conjunction with interpositional autogenous bone grafting in the atrophied posterior mandible.
In this study ten atrophied posterior mandibular regions will be augmented with autogenous interpositional particulate bone harvested from the ipsilateral retromolar area through the oblique sandwich osteotomy procedure. The mobilized segment will be stabilized by using 2.0 manipulates and screws. The graft is then covered by platelet rich fibrin membrane.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: nehal Shobair lecturer, PhD
- Phone Number: 010171181794
- Email: nehalshobair@dent.asu.edu.eg
Study Locations
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-
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Cairo, Egypt
- Recruiting
- Faculty of Dentistry Ain Shams Univeristy
-
Contact:
- nehal Shobair lecturer, Phd
- Email: nehalshobair@dent.asu.edu.eg
-
Contact:
- Phone Number: +201017181749
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Partially edentulous patients with moderate to severe posterior atrophic mandibular ridges,
- Sufficient alveolar bone width for implant placement (at least 7 mms),
- A native alveolar bone height above the mandibular alveolar canal till the alveolar crest (measuring from 5 to 9 mms),
- Adequate inter-arch space,
- The site of the graft is free from any pathologic lesion as cyst, infection or tumor.
Exclusion Criteria:
- The patients suffering from any systemic and metabolic disease that may affect normal healing of bone and soft tissue as diabetes or osteoporosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: oblique sandwich osteotomy augmenation
atrophic posterior mandibular regions wiil be augmented with autogenous interpositional particulate bone harvested from the ipsilateral retromolar area through the oblique sandwich osteotomy procedure. The mobilized segment will be stabilized by using 2.0 manipulates and screws. The graft is then covered by platelet rich fibrin membrane. |
atrophic posterior mandibular regions is augmented with autogenous interpositional particulate bone harvested from the ipsilateral retromolar area through the oblique sandwich osteotomy procedure. The mobilized segment is stabilized by using 2.0 manipulates and screws. The graft is then covered by platelet rich fibrin membrane. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical evaluation
Time Frame: 4 months
|
clinical evalauation of the occurrence of any complications after augmentation involving wound dehiscence, infection, neuro-sensory disturbance and for the stability of the augmented alveolar ridges |
4 months
|
|
Radiographic evaluation
Time Frame: 4 months
|
Linear and volumetric Measurements to calculate first the post-operative CBCT bone volume then the volume of the plate is calculated separately and subtracted from the postoperative volume. The preoperative and postoperative CBCTs and the difference in volume is calculated through subtraction of postoperative and preoperative results |
4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1415
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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