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

Cairo University (CU) logo

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)

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.

Trial contacts and locations

1

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Central trial contact

Mohamed K Hassan, MSc.

Data sourced from clinicaltrials.gov

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