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

One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis: (A Randomized Controlled Trial)

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.

Study Overview

• Status: Unknown
• Conditions: Atrophied Posterior Maxilla
• Intervention / Treatment: Procedure: Open sinus lift using chin bone graft; Procedure: Sinus lift using bone ring containing the implant.

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 12613
      • Recruiting
      • Faculty of Oral and Dental Medicine-Cairo University.
      • Contact: Mohamed K Hassan, MSc; Phone Number: 01111284444; Email: dr_mkdentistry@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. ]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.; Other Names: Lateral sinus approach with chin graft
Experimental: Sinus lift using bone ring containing the implant; Patients with atrophied posterior maxilla will undergo sinus lift using bone ring containing the implant.	Procedure: Sinus lift using bone ring containing the implant.; Patients with atrophied posterior maxilla will undergo sinus lift with chin bone ring containing the implant.; Other Names: One stage sinus lift using bone ring

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Salah Y yassin, PhD., Faculty of Oral and Dental Medicine- Cairo University

Publications and helpful links

General Publications

• Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
• Wallace SS, Froum SJ. Effect of maxillary sinus augmentation on the survival of endosseous dental implants. A systematic review. Ann Periodontol. 2003 Dec;8(1):328-43. doi: 10.1902/annals.2003.8.1.328.
• Mahesh L, Kurtzman GM, Shukla S. Trephine core: an alternative sinus lift technique. J Oral Implantol. 2014 Jul;40 Spec No:391-6. doi: 10.1563/aaid-joi-D-14-00047. Epub 2014 Mar 12. No abstract available.
• Wang PD, Klein S, Kaufman E. One-stage maxillary sinus elevation using a bone core containing a preosseointegrated implant from the mandibular symphysis. Int J Periodontics Restorative Dent. 2002 Oct;22(5):435-9.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Implant, Bone ring, Sinus lift.
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: CEBD-CU-2018-07-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No