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

Not Applicable

• Conditions: Atrophied Posterior Maxilla
• Interventions: Procedure: Sinus lift using bone ring containing the implant.; Procedure: Open sinus lift using chin bone graft

• Registration Number: NCT03590964
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-17
• Last Update Submitted: 2018-07-17
• Study First Posted: 2018-07-18
• Last Update Posted: 2018-07-18
• Study Start: 2018-08-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

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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. ]

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sinus lift using bone ring containing the implant	Sinus lift using bone ring containing the implant.	Patients with atrophied posterior maxilla will undergo sinus lift using bone ring containing the implant.
Open sinus lift using chin bone graft	Open sinus lift using chin bone graft	Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.

Primary Outcome Measures

Name	Time	Method
Survival rate of implant	One year post-operative.	The estimated annual failure rate will be assessed via clinical assessment, measuring unit (Binary yes\\ no)

Secondary Outcome Measures

Name	Time	Method
Established bone integration	Six months post operative.	Structural and functional integration of bone around implant will be assessed using a device with measuring unit scale of 1-100.
Pain intensity	One month post-operative.	Intensity of pain will be assessed using Visual analog scale (0 -10), 0 indicate no pain,10 indicate unbearable pain.
Marginal bone loss around implant	one year post operative	Bone loss around implant will be assessed using Cone Beam Computed Tomography, measuring unit (millimeter).
Sinus membrane perforation	During operation	Perforation of sinus lining will be assessed clinically, (Binary yes\\no).

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine-Cairo University.; 🇪🇬 Cairo, Giza, Egypt