One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis
Primary Purpose
Atrophied Posterior Maxilla
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Open sinus lift using chin bone graft
Sinus lift using bone ring containing the implant.
Sponsored by
About this trial
This is an interventional treatment trial for Atrophied Posterior Maxilla focused on measuring Implant, Bone ring, Sinus lift.
Eligibility Criteria
Inclusion Criteria:
- Patients with at least a unilateral atrophied posterior maxilla indicated for open sinus lift and graft.
- All ages and both sexes were included in this study.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with good general condition allowing surgical procedure under general anesthesia.
- Patients with physical and psychological tolerance.
Exclusion Criteria:
- Patients with high risk systemic diseases like uncontrolled diabetes. As uncontrolled diabetes has a negative impact on normal bone healing.
- Patients with chronic sinusitis, maxillary sinus tumor or cyst. As they will affect accuracy of the procedure.
- Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. ]
Sites / Locations
- Faculty of Oral and Dental Medicine-Cairo University.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Open sinus lift using chin bone graft
Sinus lift using bone ring containing the implant
Arm Description
Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.
Patients with atrophied posterior maxilla will undergo sinus lift using bone ring containing the implant.
Outcomes
Primary Outcome Measures
Survival rate of implant
The estimated annual failure rate will be assessed via clinical assessment, measuring unit (Binary yes\ no)
Secondary Outcome Measures
Marginal bone loss around implant
Bone loss around implant will be assessed using Cone Beam Computed Tomography, measuring unit (millimeter).
Pain intensity
Intensity of pain will be assessed using Visual analog scale (0 -10), 0 indicate no pain,10 indicate unbearable pain.
Sinus membrane perforation
Perforation of sinus lining will be assessed clinically, (Binary yes\no).
Established bone integration
Structural and functional integration of bone around implant will be assessed using a device with measuring unit scale of 1-100.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03590964
Brief Title
One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis
Official Title
One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis: (A Randomized Controlled Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophied Posterior Maxilla
Keywords
Implant, Bone ring, Sinus lift.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized controlled trial.
Parallel group study.
A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University
Equal randomization: participants with equal probabilities for intervention.
Positive controlled: Both groups receiving treatment.
Masking
None (Open Label)
Masking Description
Because the two interventions used in this trial are clearly different and easily recognized by the participants and investigators, neither the investigators nor participants can be blinded.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open sinus lift using chin bone graft
Arm Type
Active Comparator
Arm Description
Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.
Arm Title
Sinus lift using bone ring containing the implant
Arm Type
Experimental
Arm Description
Patients with atrophied posterior maxilla will undergo sinus lift using bone ring containing the implant.
Intervention Type
Procedure
Intervention Name(s)
Open sinus lift using chin bone graft
Other Intervention Name(s)
Lateral sinus approach with chin graft
Intervention Description
Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.
Intervention Type
Procedure
Intervention Name(s)
Sinus lift using bone ring containing the implant.
Other Intervention Name(s)
One stage sinus lift using bone ring
Intervention Description
Patients with atrophied posterior maxilla will undergo sinus lift with chin bone ring containing the implant.
Primary Outcome Measure Information:
Title
Survival rate of implant
Description
The estimated annual failure rate will be assessed via clinical assessment, measuring unit (Binary yes\ no)
Time Frame
One year post-operative.
Secondary Outcome Measure Information:
Title
Marginal bone loss around implant
Description
Bone loss around implant will be assessed using Cone Beam Computed Tomography, measuring unit (millimeter).
Time Frame
one year post operative
Title
Pain intensity
Description
Intensity of pain will be assessed using Visual analog scale (0 -10), 0 indicate no pain,10 indicate unbearable pain.
Time Frame
One month post-operative.
Title
Sinus membrane perforation
Description
Perforation of sinus lining will be assessed clinically, (Binary yes\no).
Time Frame
During operation
Title
Established bone integration
Description
Structural and functional integration of bone around implant will be assessed using a device with measuring unit scale of 1-100.
Time Frame
Six months post operative.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with at least a unilateral atrophied posterior maxilla indicated for open sinus lift and graft.
All ages and both sexes were included in this study.
Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
Patients with good general condition allowing surgical procedure under general anesthesia.
Patients with physical and psychological tolerance.
Exclusion Criteria:
Patients with high risk systemic diseases like uncontrolled diabetes. As uncontrolled diabetes has a negative impact on normal bone healing.
Patients with chronic sinusitis, maxillary sinus tumor or cyst. As they will affect accuracy of the procedure.
Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. ]
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed K Hassan, MSc.
Phone
01111284444
Email
dr_mkdentistry@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah Y yassin, PhD.
Organizational Affiliation
Faculty of Oral and Dental Medicine- Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine-Cairo University.
City
Cairo
State/Province
Giza
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed K Hassan, MSc
Phone
01111284444
Email
dr_mkdentistry@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24621196
Citation
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.
Results Reference
result
PubMed Identifier
14971260
Citation
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.
Results Reference
result
PubMed Identifier
18724852
Citation
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.
Results Reference
result
PubMed Identifier
12449303
Citation
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.
Results Reference
result
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One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis
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