One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis

Cairo University (CU)

Status: Unknown

Conditions: Atrophied Posterior Maxilla

Treatments: Procedure: Sinus lift using bone ring containing the implant.; Procedure: Open sinus lift using chin bone graft

Study type: Interventional

Funder types: Other

Identifiers

NCT03590964

CEBD-CU-2018-07-05

Details and patient eligibility

About

Two groups of patients with atrophy in posterior maxilla indicated for sinus lift.

First group will be subjected to open sinus lift with chin bone graft. Second group will be subjected to sinus floor elevation using a bone ring.

Full description

Two groups of patients with atrophy in posterior maxilla indicated for sinus lift.

(A) First group will be subjected to open sinus lift with chin bone graft.

• All cases will undergo surgery under general anesthesia for sinus lift and other surgery under local anesthesia for implant placement .
• Exposure of the anterior wall of maxilla according to standardized surgical approach.
• Open sinus lift and bone graft.
• After 6 months, implant will be drilled and inserted in the recipient site according to standard protocol.
• Loading on implant after 5-6 months.

(B)Second group will be subjected to sinus floor elevation using a bone ring.

• All cases will undergo surgery under local anesthesia for implant placement in the mandibular chin and other surgery under general anesthesia for sinus lift using bone ring with the implant.
• Exposure of the mandibular chin will be done under local anesthesia using a standardized surgical approach.
• Implant will be drilled and inserted in the chin according to standard protocol.
• After 3 months, second surgery under general anesthesia to place the implant and surrounding ring in the atrophied posterior maxilla.
• The bone ring containing the implant allowed to heal for 5-6 months.

Follow up:

• Clinical evaluation will be performed at the first week post-operative.
• Three months post-operative second surgery to put the implant with surrounding ring in atrophied posterior maxilla.
• Five months post-operative to the second surgery, implant will be loaded with the final restoration.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with at least a unilateral atrophied posterior maxilla indicated for open sinus lift and graft.
2. All ages and both sexes were included in this study.
3. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
4. Patients with good general condition allowing surgical procedure under general anesthesia.
5. Patients with physical and psychological tolerance.

Exclusion criteria

1. Patients with high risk systemic diseases like uncontrolled diabetes. As uncontrolled diabetes has a negative impact on normal bone healing.
2. Patients with chronic sinusitis, maxillary sinus tumor or cyst. As they will affect accuracy of the procedure.
3. Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. ]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Open sinus lift using chin bone graft

Active Comparator group

Description:

Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.

Treatment:

Procedure: Open sinus lift using chin bone graft

Sinus lift using bone ring containing the implant

Experimental group

Description:

Patients with atrophied posterior maxilla will undergo sinus lift using bone ring containing the implant.

Treatment:

Procedure: Sinus lift using bone ring containing the implant.