Evaluation of Vertical Height in Anterior Maxillary Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement
Primary Purpose
Alveolar Bone Resorption
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement
Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Resorption focused on measuring Vertical bone augmentation, Inlay bone graft, Dental Implants, Sandwich Osteotomy
Eligibility Criteria
Inclusion Criteria:
- Age range from 20-55 years. No sex predilection.
- Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- Edentulous anterior maxilla with vertically deficient alveolar ridge that is less than 10 mm measured from the crest of the alveolar ridge to the nasal floor.
- Normal vertical dimension with increased inter-arch space.
- The minimum number of missing teeth in the anterior maxillary alveolar ridge is two adjacent anterior teeth.
Exclusion Criteria:
- • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
- Previous grafting procedures in the edentulous area.
- Deficient horizontal dimensions of the alveolar ridge i.e. width is less than 5 mm.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sandwich osteotomy with simultaneous implant placement
Sandwich osteotomy using micro-plates fixation
Arm Description
This group will undergo Sandwich osteotomy procedure and segment will be fixed using the dental implants placed simultaneously during the same surgical procedure. The remaining gap will be filled using xenograft.
This group will undergo Sandwich osteotomy procedure and segment will be fixed using micro-plates and screws, and the gap will be filled using xenograft.
Outcomes
Primary Outcome Measures
Final Vertical Alveolar ridge height
Measured in millimeters from the crest of the alveolar ridge to the floor of nasal cavity using cone-beam computed tomography
Secondary Outcome Measures
Patient Satisfaction: scale from 1 to 10
Measured on a scale from 1 to 10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04022538
Brief Title
Evaluation of Vertical Height in Anterior Maxillary Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement
Official Title
Evaluation of Vertical Bone Augmentation Using Anterior Maxillary Segmental Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement, A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
August 2020 (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
Vertical bone height has always presented challenge for the clinicians especially in the anterior aesthetic zone. Therefore, this trial will attempt to compare whether better vertical bone height and implant placement technique can be achieved using simultaneous implant placement with the sandwich osteotomy, which is a time saving procedure performed in a single stage surgery; when compared to using fixation plates to support the segment followed by delayed implant placement.
Detailed Description
Fixation plates are usually used to support the segmentalized bone segment during vertical bone augmentation using sandwich osteotomy and inlay bone grafting; to minimize movement of the bone segment and allow for new bone formation. Therefore, the aim of this study is to evaluate vertical bone height achieved at the anterior maxilla in vertical segmental sandwich osteotomy with simultaneous implant placement versus the same technique using fixation plates.
Description of Sandwich Osteotomy procedure to be done:
A full thickness pyramidal flap with buccal paracrestal incision and two vertical releasing incisions slightly divergent to each other will be made. Then the mucoperiosteal flap will be reflected exposing the whole buccal cortical plate without reflection of the palatal mucosa.
The palatal mucosa will not be reflected to avoid disturbance of blood supply to the mobilized segment for proper healing.
With a Tungsten carbide disc - 1 mm in thickness and 10 mm in diameter - the alveolar bone will be segmented using a horizontal cut 3 to 5 mm apical to the crest of the ridge, and two lateral vertically oblique cuts 1-2 mm away from adjacent teeth roots slightly converging toward the alveolar crest or almost parallel to each other; thus creating a trapezoid-shaped bone segment pedicled on the attached palatal tissues.
The horizontal and the two vertical cuts will then be revised using a set of graduated ridge splitting (fine chisels) osteotomes of sequential width and a light weight mallet to ensure that the surgical cuts are down to spongy bone.
The segment will then be mobilized crestally, pedicled on the non-reflected palatal tissue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Resorption
Keywords
Vertical bone augmentation, Inlay bone graft, Dental Implants, Sandwich Osteotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sandwich osteotomy with simultaneous implant placement
Arm Type
Experimental
Arm Description
This group will undergo Sandwich osteotomy procedure and segment will be fixed using the dental implants placed simultaneously during the same surgical procedure. The remaining gap will be filled using xenograft.
Arm Title
Sandwich osteotomy using micro-plates fixation
Arm Type
Active Comparator
Arm Description
This group will undergo Sandwich osteotomy procedure and segment will be fixed using micro-plates and screws, and the gap will be filled using xenograft.
Intervention Type
Procedure
Intervention Name(s)
Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement
Other Intervention Name(s)
Inlay alveolar bone grafting with simultaneous implant placement
Intervention Description
Following the Sandwich Osteotomy procedure described in the study description, the following steps will be done:
The first implant osteotomy will be prepared and placed while a chisel is placed between the down fractured segment and the basal bone, and then the second implant will be installed.
The gap between the transported segment and the basal bone will be filled with xenograft particulate bone substitute.
Finally, periosteal scoring will be done to allow tension-free interrupted closure using 3-0 vicryl suturing material.
Intervention Type
Procedure
Intervention Name(s)
Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation
Intervention Description
Following the Sandwich Osteotomy procedure described in the study description, the following steps will be done:
The created gap between the transported segment and the basal bone will be filled with xenograft particulate bone substitute.
The mobilized segment is to be fixed to the basal bone using micro-plates and micro-screws.
Finally, periosteal scoring will be done to allow tension-free interrupted closure using 3-0 vicryl suturing material.
Primary Outcome Measure Information:
Title
Final Vertical Alveolar ridge height
Description
Measured in millimeters from the crest of the alveolar ridge to the floor of nasal cavity using cone-beam computed tomography
Time Frame
4 months postoperatively
Secondary Outcome Measure Information:
Title
Patient Satisfaction: scale from 1 to 10
Description
Measured on a scale from 1 to 10
Time Frame
4 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age range from 20-55 years. No sex predilection.
Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
Edentulous anterior maxilla with vertically deficient alveolar ridge that is less than 10 mm measured from the crest of the alveolar ridge to the nasal floor.
Normal vertical dimension with increased inter-arch space.
The minimum number of missing teeth in the anterior maxillary alveolar ridge is two adjacent anterior teeth.
Exclusion Criteria:
• Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
Previous grafting procedures in the edentulous area.
Deficient horizontal dimensions of the alveolar ridge i.e. width is less than 5 mm.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evidence-based Dentistry Committe at OMFS dept.
Phone
+201001932020
Email
surgeryeb@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Aldubai
Organizational Affiliation
Master's Degree Candidate at Faculty of Dentistry, Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Vertical Height in Anterior Maxillary Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement
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