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RecruitingNCT06700772Updated Nov 22, 2024

Histomorphometric and Radiographic Evaluation of Bone Following Maxillary Sinus Augmentation

A Phase 1 interventional study of mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone and mixing autogenous bone with bovine bone in Sinus Floor Elevation, sponsored by Cairo University. Recruiting at 2 sites in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Cairo University · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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

Read the detailed description

Two groups of patients with partial edentulous posterior maxilla with pneumatized sinus and need dental implant. First group will be subjected to open sinus lifting using autogenous bone mixed with bone marrow aspirate concentrate cells from maxillary tuberosity (the study group) and the second group will be subjected to open sinus lifting using autogenous bone mixed with bovine bone (control group) Intervention Eligible patients will be equally randomized in a parallel two arm groups . The study group (open sinus lifting using bone marrow aspirate concentrate from maxillary tuberosity mixed with bovine bone) Procedure will be performed under local anesthesia A 20 gauge needle will be inserted in the maxillary tuberosity area through the palatal aspect until aspiration is positive.

Aspirate will be collected in a heparin-treated tube (2000:1) using 1ml of anticoagulant acid citrate dextrose solution for every 15ml of bone marrow aspiration.

Aspirate will be centrifuged at 3000 rpm for 10 minutes to separate the BMAC . The upper layer containing plasma and platelets will be collected using a sterile pipette, leaving the bone marrow aspirate bone marrow aspirate will be mixed with bovine bone and then the mixture will be applied in open sinus lifting Control group (open sinus lifting using autogenous bone from retromolar area mixed with bovine bone) After injection of local anesthesia a crestal incision will be carried out from a point corresponding to the occlusal surface along the external oblique ridge and extending anteriorly and inferiorly through the buccal mucosa, parallel to the gingival margin of the mandibular molars.

The subperiosteal dissection will be extended to expose the ascending ramus and the retromolar region.

Auto chip maker bur will be used to drill out some autogenous bone particulate from retromolar which will be mixed with xenogeneic graft with a 50% to 50% ratio respectively. this mixture will be packed into the grafted site .

Post operative instructions and follow up:

Administration of:

  1. Antibiotics (Amoxicillin 1g twice daily for 5 days) to prevent any chance of infection.
  2. Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days) to avoid any chance of edema or pain or swelling
  3. Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse will be prescribed for 60 seconds two times a day for 14 days.

    • The patient will be instructed to follow up for the next months before implant placement

Patient self-care instructions:

  1. Application of an ice bag to the treated area for the first 24 hours.
  2. Avoid any brushing and trauma to the surgical site for one week
  3. avoid smoking
  4. The patient will be asked to keep on clear fluid diet for the first 24 hours then a soft diet to be maintained for the next day.
  5. Strict oral hygiene measures in the form of regular use of toothbrush and antiseptic mouthwash starting week after surgery. Warm saline oral rinsing three times daily for one week.

Postsurgical procedure (six months lateral sinus lifting) Local anaesthesia will be administered by infiltration or nerve block to achieve the necessary anaesthesia.

A flap will be raised at the presurgical site. A core biopsy will be harvested by introducing a core drill bit in place of an initial drill.

Sequential drilling will take place to prepare osteotomy to the right size to receive an implant.

Implant will be placed in the osteotomy with the platform flush with the bone. Flap closure will be achieved by interrupted 5-0 sutures. Outcomes Primary outcome quantity of bone gain Secondary outcome quality of bone gain

02

Conditions studied

  • Sinus Floor Elevation

Keywords

  • Bone replacement materials
  • Bone substitutes
  • Maxillary sinus augmentation
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Smokers
  2. Pregnant females
  3. Patient with medical condition that contraindicates surgical procedures.
  4. Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy).
  5. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
  6. Patients have chronic sinus disease.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

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

    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

  • Active comparator
    Open sinus lifting using autogenous bone mixed with bovine bone

    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

  • Proceduremixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone

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

  • Proceduremixing autogenous bone with bovine bone

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

06

What researchers measure

Primary outcomes

  1. Radiographic assessment

    Calculation of vertical bone gain quantity using cone beam computed tomography

    Time frame: 6 months postoperative

Secondary outcomes

  1. Histomorphometric analysis

    Assessment of bone quality after open sinus lifting this bone will be harvested using trephine bur .and bone analysis will be done using H\&E stain by microscope

    Time frame: 6 months postoperative

07

Study locations

2 of 2 sites recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06700772
Lead sponsor
Cairo University
Responsible party
Alaa Megahed Hassan Abdullah (Dentist, Cairo University) — Principal investigator
First posted
Nov 22, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Nov 22, 2024

Study contacts

Alaa Hassan, BSc
Contact
Alaa.abdullah@dentistry.cu.edu.eg
01026980299
Alaa Hassan
Contact
Alaamegahed@gmail.com
01026980299
Mohammed Mounir shaker
study director · Faculty of oral and dental medicine cairo university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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