Histomorphometric and Radiographic Evaluation of Bone Following Maxillary Sinus Augmentation

NCT06700772 | Recruiting Phase 1 DMC

• 1 other identifier: CEBD-CU-12-5-2024
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

Two groups of patients with posterior vertical deficient maxillary alveolar ridge with pneumatized sinus and needing dental implant . First group will be subjected to open sinus lifting using autogenous bone mixed with bone marrow aspirate concentrate cells from maxillary tuberosity and the second group will be subjected to open sinus lifting using autogenous bone mixed with bovine bone

Conditions

Sinus Floor Elevation

Keywords

Bone replacement materials; Bone substitutes; Maxillary sinus augmentation

Outcome Measures

Primary Outcomes (1)

• Radiographic assessment

  Calculation of vertical bone gain quantity using cone beam computed tomography

  6 months postoperative

Secondary Outcomes (1)

• Histomorphometric analysis

  6 months postoperative

Study Arms (2)

open sinus lifting using bone marrow aspirate from maxillary tuberosity mixed with bovine bone

EXPERIMENTAL

Under local anesthesia a 20 gauge needle that will be inserted inside tuberosity until aspiration is positive and then the aspirate will be collected in heparin treated tube (1ml anticoagulant citrate dextrose) for each 15 ml of aspirate The aspirate will be centrifuged at 3000 rpm for 10 minutes to separate the BMAC The upper layer containing the plasma and platelet will be separated using sterile peptide tube leaving the BMAC Mixing BMAC with bovine bone (2cc of bio-oss) and it will be applied in grafted sinus

Procedure: mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone

Open sinus lifting using autogenous bone mixed with bovine bone

ACTIVE COMPARATOR

After injection of local anesthesia a crystal incision will be done from a point corresponding to occlusal surface along external oblique ridge and extending anteriorly and inferiorly through the buccal mucosa Subperiosteal dissection will be done to expose the retromolar area ACM bur will be used to collect autogenous bone and mixing it with bovine bone 50 : 50 Then this mixture will be packed into the grafted area

Procedure: mixing autogenous bone with bovine bone

Interventions

mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone PROCEDURE

open sinus lifting using bone marrow aspirate concentrate from maxillary tuberosity and mixing it with bovine bone .

open sinus lifting using bone marrow aspirate from maxillary tuberosity mixed with bovine bone

mixing autogenous bone with bovine bone PROCEDURE

open sinus lifting using autogenous bone from retromolar area mixed with bovine bone

Open sinus lifting using autogenous bone mixed with bovine bone

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with missing maxillary teeth with pneumatized sinus and remaining bone height \<5mm
• Patients with healthy systemic condition (Medically free)
• Adequate inter-arch space for placement of the implant prosthetic part.
• Good oral hygiene
• Cooperative patients who are willing to commit for 6 months follow up

You may not qualify if:

• Smokers
• Pregnant females
• Patient with medical condition that contraindicates surgical procedures.
• Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy).
• Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
• Patients have chronic sinus disease.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of oral and dental medicine - cairo university

Cairo, New Cairo, 12613, Egypt

RECRUITING

Faculty of oral and dental medicine - cairo university

Cairo, 12613, Egypt

RECRUITING

Related Links

• Human maxillary tuberosity and jaw periosteum as sources of osteoprogenitor cells for tissue engineering.
• Stem cells in dentistry--part I: stem cell sources.

Study Officials

• Mohammed Mounir shaker

  Faculty of oral and dental medicine cairo university

  STUDY DIRECTOR

Central Study Contacts

Alaa Hassan, BSc

CONTACT

01026980299; Alaa.abdullah@dentistry.cu.edu.eg

Alaa Hassan

CONTACT

01026980299; Alaamegahed@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None. Because the two interventions used in this trial are clearly different and can be easily recognized by the participant and investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Model Details: A Randomized clinical trial A trial will be conducted in hospital of oral and maxillofacial surgery department.faculty of oral and dental medicine Cairo university Equal randomization of participant Both groups receiving treatment Each group of patient receiving a single treatment simultaneously

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: November 22, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)