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

Fixation Free Sandwich Osteotomy for Vertical Ridge Augmentation in Aesthetic Zone Versus Conventional Sandwich Osteotomy: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrophic Maxilla; Vertical Ridge Deficiency
• Intervention / Treatment: Procedure: vertical augmentation

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 3753450
    • Cairo University
    • Contact: Heba A. Ammar, MSc; Phone Number: 00201147497876 00201551574205; Email: heba.ammar@dentistry.cu.edu.eg
    • Contact: Tarek A. El-ghareeb, PhD; Phone Number: 00201282931864 00201227418235; Email: T.elghareeb@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fixation free; sandwich osteotomy with Interpositional graft without fixation.	Procedure: vertical augmentation; sandwich osteotomy with an Interpositional inlay graft; Other Names: segmental osteotomy with Interpositional graft
Active Comparator: conventional sandwich osteotomy; sandwich osteotomy with Interpositional graft with fixation.	Procedure: vertical augmentation; sandwich osteotomy with an Interpositional inlay graft; Other Names: segmental osteotomy with Interpositional graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographical bone gain	amount of vertical bone gain in millimeter using cone beam CT scan	4-months
radiographical bone change	amount of bone change in millimeter using cone beam CT scan	4- months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pain	pain measure on a scale using visual analog scale	1-3days
clinical edema	measure by edema index in terms of grades with minimum 1(better outcome and maximum 4( worse outcome)	1-7 days
clinical infection	binary as present or not present	1-5 days
clinical dehiscence	binary as present or not present	1-30 days

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: sandwich osteotomy; vertical augmentation,; aesthetic zone; Interpositional graft; fixation free
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: segmental osteotomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No