Back to resultsTitanium Mesh Versus Collagen Membrane for Closure of Window in Maxillary Sinus Elevation With Implant Placement
Primary Purpose
Edentulous; Alveolar Process, Atrophy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
titanium mesh
collagen membrane
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous; Alveolar Process, Atrophy
Eligibility Criteria
Inclusion Criteria:
- no signs of sinus pathology non or light smokers less than 20 cigarettes per day no systemic disease that may affect normal healing no pscychiatric problems no history of neoplasms or radiation therapy to the head and neck no previous bone augmentation to implant site
Exclusion Criteria:
- Sinus pathology. Heavy smokers more than 20 cigarettes per day Patients with systemic disease that may affect normal healing. Psychiatric problems Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
Sites / Locations
- Faculty of Dentistry, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
collagen membrane group
titanium mesh group
Arm Description
Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with collagen membrane
Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with titanium mesh
Outcomes
Primary Outcome Measures
bone height
Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane .
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03401554
Brief Title
Titanium Mesh Versus Collagen Membrane for Closure of Window in Maxillary Sinus Elevation With Implant Placement
Official Title
Titanium Mesh Versus Collagen Membrane for Closure of Lateral Window Approach in Maxillary Sinus Floor Elevation With Simultaneous Implant Placement. Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 13, 2017 (Actual)
Primary Completion Date
November 22, 2017 (Actual)
Study Completion Date
December 17, 2017 (Actual)
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
Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane.Evaluation the quality of new bone gained when using of the titanium mesh to close the lateral window of the maxillary sinus as a new option for tenting compared to collagen membrane.
Detailed Description
this study is aimed to review the bone height, quality and closure of lateral osteotomy used for maxillary sinus floor lifting comparing titanium mesh to collagen membrane.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous; Alveolar Process, Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
collagen membrane group
Arm Type
Active Comparator
Arm Description
Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with collagen membrane
Arm Title
titanium mesh group
Arm Type
Experimental
Arm Description
Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with titanium mesh
Intervention Type
Procedure
Intervention Name(s)
titanium mesh
Intervention Description
closing the lateral window for maxillary sinus floor elevation with titanium mesh
Intervention Type
Procedure
Intervention Name(s)
collagen membrane
Intervention Description
closing the lateral window for maxillary sinus floor elevaion with collagen membrane
Primary Outcome Measure Information:
Title
bone height
Description
Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane .
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
no signs of sinus pathology non or light smokers less than 20 cigarettes per day no systemic disease that may affect normal healing no pscychiatric problems no history of neoplasms or radiation therapy to the head and neck no previous bone augmentation to implant site
Exclusion Criteria:
Sinus pathology. Heavy smokers more than 20 cigarettes per day Patients with systemic disease that may affect normal healing. Psychiatric problems Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa Mahmoud, Bds
Organizational Affiliation
Study principal investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
State/Province
الجيزة
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Titanium Mesh Versus Collagen Membrane for Closure of Window in Maxillary Sinus Elevation With Implant Placement
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