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NCT Number: NCT06700772

Histomorphometric and Radiographic Evaluation of Bone Following Maxillary Sinus Augmentation

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

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of oral and dental medicine - cairo university, Cairo, New Cairo, Egypt

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About this study

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:

  • Antibiotics (Amoxicillin 1g twice daily for 5 days) to prevent any chance of infection.
  • Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days) to avoid any chance of edema or pain or swelling
  • 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:

  • Application of an ice bag to the treated area for the first 24 hours.
  • Avoid any brushing and trauma to the surgical site for one week
  • avoid smoking
  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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 .

mixing autogenous bone with bovine bone

Procedure

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

Primary outcomes

  1. Radiographic assessment

    Time frame: 6 months postoperative

    Calculation of vertical bone gain quantity using cone beam computed tomography

Secondary outcomes

  1. Histomorphometric analysis

    Time frame: 6 months postoperative

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Hassan

CONTACT

[email protected]

01026980299

Alaa Hassan, BSc

CONTACT

[email protected]

01026980299

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Histomorphometric and Radiographic Assessment of Bone Following Maxillary Sinus Augmentation Using Bone Marrow Concentrate Cells From the Maxillary Tuberosity Mixed With Bovine Bone Versus Autogenous Bone Mixed With Bovine Bone: RCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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