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Fixation Free Sandwich Osteotomy With an Interpositional Inlay Graft in Compere to Conventional Sandwich Osteotomy (sandwich)

Primary Purpose

Vertical Ridge Deficiency, Atrophic Maxilla

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
vertical augmentation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertical Ridge Deficiency focused on measuring sandwich osteotomy, vertical augmentation,, aesthetic zone, Interpositional graft, fixation free

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Both sex Adulte patient (18-60 y.) Highly motivated patient with good oral hygiene No systematic diseases or conditions known to alter bone healing. No local pathosis that may interfere with bone healing. No recent history of augmentation procedure at the same area. Criteria of the edentulous ridge: The anterior maxillary vertical dimension is minimum 10mm, measured from the crest of the ridge to the nasal floor. Horizontal ridge dimension remains normal; at least 6mm. The minimum number of the missing teeth is minimum 2 teeth and the maximum will be the six anteriors. There will be increased inter-arch space compared with the adjacent teeth. Exclusion Criteria: uncontrolled Diabetes mellitus (DM) pregnancy uncontrolled local factors(periodontitis), or acute infection related to the aera. smoking: more than 20 cigarettes \day intravenous bisphosphonate patients who had received radiation treatment in the head and neck region. previous bone augmentation in the site within 6 months.

Sites / Locations

  • Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

fixation free

conventional sandwich osteotomy

Arm Description

sandwich osteotomy with Interpositional graft without fixation.

sandwich osteotomy with Interpositional graft with fixation.

Outcomes

Primary Outcome Measures

radiographical bone gain
amount of vertical bone gain in millimeter using cone beam CT scan
radiographical bone change
amount of bone change in millimeter using cone beam CT scan

Secondary Outcome Measures

clinical pain
pain measure on a scale using visual analog scale
clinical edema
measure by edema index in terms of grades with minimum 1(better outcome and maximum 4( worse outcome)
clinical infection
binary as present or not present
clinical dehiscence
binary as present or not present

Full Information

First Posted
October 10, 2023
Last Updated
October 18, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06089928
Brief Title
Fixation Free Sandwich Osteotomy With an Interpositional Inlay Graft in Compere to Conventional Sandwich Osteotomy
Acronym
sandwich
Official Title
Fixation Free Sandwich Osteotomy for Vertical Ridge Augmentation in Aesthetic Zone Versus Conventional Sandwich Osteotomy: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
January 30, 2026 (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
No

5. Study Description

Brief Summary
The atrophatic anterior maxilla present a considerable challenge for both surgical and prosthetic rehabilitation, as it may require bone augmentation to enable implant placement. The techniques proposed for vertical augmentation of the alveolar ridge include distraction osteogenesis, only grafting, and sandwich osteoplasty. Sandwich osteotomy is reported to provide more stable and predictable results with respect to the height of the alveolar ridge. The main advantage of osteotomy techniques that employ Interpositional bone grafts is reported to be the improved blood supply in the augmented region.
Detailed Description
the investigators aim to evaluate the radiographical, clinical differences of newly formed bone following vertical maxillary ridge augmentation using sandwich inlay with autogenous bone block from the rums without fixation (study group I) compared to same procedure with fixation (micro plates and screw) (control group). description of intervention: 1) diagnostic procedure: All Participant will be selected according to inclusion and exclusion criteria. Comprehensive clinical examination and understanding of patient's chief complaints will be carried out. All participants will be informed about the surgical treatment procedure and will provide their written consent to participate in the study. Preoperative panoramic radiograph will be requested prior as general screening for any pathosis and primary maxillary anterior residual bone height assessment. A (CBCT) scan will be requested for each patient to confirm amount of horizontal and vertical bone, to exactly measure the amount of bone height and to plan and guide surgical procedures of block graft. Alginate Impressions of upper & lower jaws will be taken for acquiring diagnostic dental casts. intra-surgical procedure : Harvesting procedures of the mandibular ramus block graft: After administering local anesthesia, a soft tissue incision will be made in the posterior mandible to create an envelope flap similar to that created in a third molar extraction, with an external oblique incision extending anteriorly into the buccal sulcus of the respective molar sites. A mucoperiosteal full-thickness flap will be then reflected with a sharp periosteal elevator, exposing the lateral aspect of the ramus. Osteotomies to take ABB will be performed in the ramus using trephine drills. The size of the block depended on the size of the graft needed. The size of the graft will be adjected with diamond discs under saline irrigation. Donor sites will be closed after the bone graft procedure will be completed. Recipient site preparation: Following the administration of local anesthesia, a soft tissue incision will be performed. After a full-thickness mucoperiosteal flap will be reflected, the alveolar bone exposed. The edentulous area and the residual bone ridge will be prepared carefully to receive the bone graft; the defect dimensions will be measured with a periodontal probe to determine the approximate size of the block graft to be harvested or amount of particle bone graft needed. Three full-thickness bony cuts will be performed. Two vertical stop cuts will be made using a tungsten carbide disc at the distal ends of the mid-crestal bony cut on the facial surface of alveolar ridge; the vertical cuts will be 3 mm from the neighboring teeth. The above-described cuts will be revised using ridge-splitting osteotomes (fine chisels) of sequential width (2 mm, 3 mm) and a lightweight mallet. The rectangular bony segment (transport segment) will be mobilized occlusally and be pedicled on the palatal mucoperiosteum. The autogenous blocks will be fitted between the mobilized segment and the basal bone, and the remining gap will be filled with particulated autogenous bone, in test group; there is no mean of fixation will be used while in the control group the segment will be fixed using micro-plates and screws. Scoring will be done to allow tension-free closure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertical Ridge Deficiency, Atrophic Maxilla
Keywords
sandwich osteotomy, vertical augmentation,, aesthetic zone, Interpositional graft, fixation free

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
clinical and radiographical comparisons of newly formed bone following vertical ridge augmentation which is achieved by use sandwich osteotomy with Interpositional inlay graft (ramus block) without fixation (test group), and same procedure with using micro-plates and screws as a mean of fixation (control group).
Masking
ParticipantOutcomes Assessor
Masking Description
both the participant and outcome assessor would not know to which group of study they belong investigator can not be masking
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fixation free
Arm Type
Active Comparator
Arm Description
sandwich osteotomy with Interpositional graft without fixation.
Arm Title
conventional sandwich osteotomy
Arm Type
Active Comparator
Arm Description
sandwich osteotomy with Interpositional graft with fixation.
Intervention Type
Procedure
Intervention Name(s)
vertical augmentation
Other Intervention Name(s)
segmental osteotomy with Interpositional graft
Intervention Description
sandwich osteotomy with an Interpositional inlay graft
Primary Outcome Measure Information:
Title
radiographical bone gain
Description
amount of vertical bone gain in millimeter using cone beam CT scan
Time Frame
4-months
Title
radiographical bone change
Description
amount of bone change in millimeter using cone beam CT scan
Time Frame
4- months
Secondary Outcome Measure Information:
Title
clinical pain
Description
pain measure on a scale using visual analog scale
Time Frame
1-3days
Title
clinical edema
Description
measure by edema index in terms of grades with minimum 1(better outcome and maximum 4( worse outcome)
Time Frame
1-7 days
Title
clinical infection
Description
binary as present or not present
Time Frame
1-5 days
Title
clinical dehiscence
Description
binary as present or not present
Time Frame
1-30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both sex Adulte patient (18-60 y.) Highly motivated patient with good oral hygiene No systematic diseases or conditions known to alter bone healing. No local pathosis that may interfere with bone healing. No recent history of augmentation procedure at the same area. Criteria of the edentulous ridge: The anterior maxillary vertical dimension is minimum 10mm, measured from the crest of the ridge to the nasal floor. Horizontal ridge dimension remains normal; at least 6mm. The minimum number of the missing teeth is minimum 2 teeth and the maximum will be the six anteriors. There will be increased inter-arch space compared with the adjacent teeth. Exclusion Criteria: uncontrolled Diabetes mellitus (DM) pregnancy uncontrolled local factors(periodontitis), or acute infection related to the aera. smoking: more than 20 cigarettes \day intravenous bisphosphonate patients who had received radiation treatment in the head and neck region. previous bone augmentation in the site within 6 months.
Facility Information:
Facility Name
Cairo university
City
Cairo
ZIP/Postal Code
3753450
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heba A. Ammar, MSc
Phone
00201551574205
Ext
00201147497876
Email
heba.ammar@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Tarek A. El-ghareeb, PhD
Phone
00201227418235
Ext
00201282931864
Email
T.elghareeb@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected individual participant data including diagnosis, treatment plane, surgical intervention, outcome assessment, results will be shared
IPD Sharing Time Frame
4-months follow-up
IPD Sharing Access Criteria
open

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Fixation Free Sandwich Osteotomy With an Interpositional Inlay Graft in Compere to Conventional Sandwich Osteotomy

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