Implant Placement With Corticocancellous Bone Block vs Mineralized Plasmatic Matrix in Maxillary Sinus Lifting

NCT06073912 | Unknown

• 1 other identifier: 12323
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Maxillary sinus floor elevation is a predictable and effective procedure for increasing the height of the residual bone in the posterior maxilla. The sinus lift procedure is basically performed using Conventional lateral sinus floor elevation (CLSFE) when RBH \< 5 mm. The use of autogenous corticocancellous bone block allows the simultaneous placement of an implant in the severely atrophic maxilla. Autogenous corticocancellous block will be applied in these patients to decrease the number of surgical interventions and the complications related to the surgery, without any additional risk, as well as to provide graft stabilization with the implant itself, using a mechanism similar to that of a screw and nut. Although the traditional application of sticky bone inside the sinus gives the benefit of moldable shaping and accurate fit into the recipient bony cavity which hardens and allows for implant osteotomy and installation with adequate implant stability. Limited comparative studies of both techniques had been introduced to the literature. This study is aimed to compare the quantity of bone gain after open sinus lift and augmentation using autogenous corticocancellous bone blocks from the chin area versus autogenous particulate mineralized plasmatic matrix (sticky bone) graft used as control group. The primary outcome which is amount of bone gain will be measured and secondary stability of the implant.

Conditions

Maxillary Sinus Floor Elevation

Outcome Measures

Primary Outcomes (1)

• bone width and height gain

  Bone width and height in millimeter using CBCT

  4 months

Secondary Outcomes (1)

• ISQ (Implant Stability Quotients) score secondary implant stability

  6 months

Study Arms (2)

Autogenous corticocancellous block

EXPERIMENTAL

Autogenous bone graft harvested as a block from the chin area

Procedure: Open sinus lifting; Procedure: Collecting blood sample; Procedure: Bone graft harvesting; Procedure: Autogenous corticocancellous block graft; Device: Centrifuge

Mineralized plasmatic matrix

ACTIVE COMPARATOR

Mix of patient's PRP and autogenous particulate graft

Procedure: Open sinus lifting; Procedure: Collecting blood sample; Procedure: Bone graft harvesting; Procedure: Mineralized plasmatic matrix graft; Device: Centrifuge; Device: ACM bur

Interventions

Open sinus lifting PROCEDURE

Sinus lateral window to graft the floor of the sinus using sinus red diamond stone

Autogenous corticocancellous block; Mineralized plasmatic matrix

Collecting blood sample PROCEDURE

Blood sample is collected to harvest PRP and PRF

Autogenous corticocancellous block; Mineralized plasmatic matrix

Bone graft harvesting PROCEDURE

Bone graft harvesting from the chin area

Autogenous corticocancellous block; Mineralized plasmatic matrix

Autogenous corticocancellous block graft PROCEDURE

Simultaneous implant placement with sinus lifting and grafting using autogenous corticocancellous block, stabilized inside the sinus using clamp or screws that will be removed before closure

Autogenous corticocancellous block

Mineralized plasmatic matrix graft PROCEDURE

Simultaneous implant placement with sinus lifting and grafting using mineralized plasmatic matrix that is formed using PRP of the patient mixed with particulate autogenous graft from the chin area

Mineralized plasmatic matrix

Centrifuge DEVICE

Centrifuge will be needed to get the PRP in the Comparator group and PRP in both groups

Autogenous corticocancellous block; Mineralized plasmatic matrix

ACM bur DEVICE

Auto Chip Maker will be used to collect the autogenous particulate bone graft for the sticky bone graft

Mineralized plasmatic matrix

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with edentulous vertically deficient posterior maxillary ridge with remaining alveolar ridge bone height \<4=/ mm.
• Both males as well as females without any active periodontal disease.
• All patients are in a good health with no systemic, immunologic, or debilitating diseases that could affect normal bone healing.
• Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
• The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
• Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

You may not qualify if:

• On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
• General contraindications to implant surgery.
• Remaining ridges\>5mm
• Subjected to irradiation in the head and neck area less than 1 year before implantation.
• Untreated periodontitis.
• Poor oral hygiene and motivation.
• Pregnant or nursing.
• Substance abuse/smoking.
• Psychiatric problems or unrealistic expectations.
• Severe bruxism or clenching.
• Treated or under treatment with intravenous amino-bisphosphonates.
• Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
• Active infection, current or previous pathology or severe inflammation in the area intended for implant placement.
• Need of bone augmentation procedures at implant placement site.
• Unable to open mouth sufficiently to accommodate the surgical tooling.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: October 10, 2023
• Study Start: December 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10