Assessment of GBR in Augmentation of Horizontally Atrophic Maxillary Ridge Using Collagen Membrane Versus Using Titanium Mesh
Primary Purpose
Horizontal Ridge Deficiency
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
titanium mesh
collagen membrane (Sausage technique)
Sponsored by
About this trial
This is an interventional treatment trial for Horizontal Ridge Deficiency
Eligibility Criteria
Inclusion Criteria:
- Patients with horizontal atrophied maxillary ridge (thin ridge) less than 4mm.
- 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 physical and psychological tolerance
Exclusion Criteria:
- Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing. 8
- Heavy smokers.4
- Alcohol or drug abuse
- Gingival bleeding or full mouth plaque index ≥ 25%.4
- Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. 9
- Unavailability for regular follow-ups
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
titanium mesh
collagen membrane(Sausage technique)
Arm Description
using non resorbable titanium mesh to fix and cover the onlay bone graft mixture to the atrophic maxillary ridge.
using resorbable collagen membrane with the sausage technique to fix the onlay bone graft mixture to the resorbed atrophic maxillary ridge
Outcomes
Primary Outcome Measures
membrane exposure
clinical postoperative complications as flap dehiscence and membrane exposure into the oral cavity, its a binary outcome (yes/No) examined and recorded by the investigator.
infection
suppuration collection related to the membrane and flap, its a binary outcome (yes/No) examined and recorded by the investigator.
inflammation
redness and tenderness of the flap, its a binary outcome (yes/No) examined and recorded by the investigator.
Secondary Outcome Measures
bone width gain
the amount of bone gained( in millimeter) after augmentation compared to the initial ridge thickness measured clinically using a caliper 2 mm below the crest of the ridge, and radiographically using the Planmeca Promax 3D CBCT unit which will be viewed on planmeca romexis software to calculate the measures needed in millimeter by the outcome assessor.
bone quality
histomorphometric analysis of the bone biopsy taken from the augmented bone to show the quality of the formed bone and the percentage of every type of tissue formed in the specimen taken( unit is area percentage %)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03635658
Brief Title
Assessment of GBR in Augmentation of Horizontally Atrophic Maxillary Ridge Using Collagen Membrane Versus Using Titanium Mesh
Official Title
Assessment of Guided Bone Regeneration in Augmentation of Horizontally Atrophic Maxillary Ridge Using Collagen Membrane Versus Using Titanium Mesh: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
October 1, 2020 (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
5. Study Description
Brief Summary
this study is aiming to Assess postoperative complications and bone quality and quantity in augmentation of horizontally atrophic maxillary ridge using a 1:1 mixture of autograft and xenograft particulate bone covered with collagen membrane with the new Sausage technique™ versus using the same mixture covered with titanium mesh.
Detailed Description
patients with atrophic maxillary ridge < 4 mm will be selected in this study for augmentation for future implant placement. The full thickness flap will be elevated including one extra tooth on each side of the edentulous area or if completely edentulous 5 mm on each side.. the bone bed will be prepared by cleaning any debris and Multiple decortication holes will be performed with a 2.0 mm round bur. the harvested bone from the chin is then mixed with the xenograft with ratio 1:1 and then put on the recipient site and will be covered with a collagen membrane with the Sausage technique (intervention group) and the other group the graft will be covered with titanium mesh (control group).
flap is repositioned and sutured. followup for 6 months and then CBCT is done. Reopening after 6 months, core biopsy is taken by a 2 mm thickness trephine from the healed augmented bone at the site of implant placement and will be sent for histomorphometric analysis and the bone thickness (buccolingual ) dimension is measured using a caliper and from the CBCT (cone beam CT) the bone width gain will be calculates and recorded.
postoperative complications( infection, wound dehiscence or membrane exposure) will be monitored and recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Horizontal Ridge Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
the participants are divided into two groups one control and the other is the intervention
Masking
None (Open Label)
Masking Description
because the two interventions used in this trial are clearly different and easily recognized by the investigator and the participants. neither the participant nor the investigator could be blinded
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
titanium mesh
Arm Type
Active Comparator
Arm Description
using non resorbable titanium mesh to fix and cover the onlay bone graft mixture to the atrophic maxillary ridge.
Arm Title
collagen membrane(Sausage technique)
Arm Type
Experimental
Arm Description
using resorbable collagen membrane with the sausage technique to fix the onlay bone graft mixture to the resorbed atrophic maxillary ridge
Intervention Type
Procedure
Intervention Name(s)
titanium mesh
Intervention Description
the non resorbable titanium mesh is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge.
Intervention Type
Procedure
Intervention Name(s)
collagen membrane (Sausage technique)
Intervention Description
the resorbable collagen membrane is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge.
Primary Outcome Measure Information:
Title
membrane exposure
Description
clinical postoperative complications as flap dehiscence and membrane exposure into the oral cavity, its a binary outcome (yes/No) examined and recorded by the investigator.
Time Frame
within 3 weeks
Title
infection
Description
suppuration collection related to the membrane and flap, its a binary outcome (yes/No) examined and recorded by the investigator.
Time Frame
10 days
Title
inflammation
Description
redness and tenderness of the flap, its a binary outcome (yes/No) examined and recorded by the investigator.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
bone width gain
Description
the amount of bone gained( in millimeter) after augmentation compared to the initial ridge thickness measured clinically using a caliper 2 mm below the crest of the ridge, and radiographically using the Planmeca Promax 3D CBCT unit which will be viewed on planmeca romexis software to calculate the measures needed in millimeter by the outcome assessor.
Time Frame
at 6 months
Title
bone quality
Description
histomorphometric analysis of the bone biopsy taken from the augmented bone to show the quality of the formed bone and the percentage of every type of tissue formed in the specimen taken( unit is area percentage %)
Time Frame
at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with horizontal atrophied maxillary ridge (thin ridge) less than 4mm.
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 physical and psychological tolerance
Exclusion Criteria:
Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing. 8
Heavy smokers.4
Alcohol or drug abuse
Gingival bleeding or full mouth plaque index ≥ 25%.4
Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. 9
Unavailability for regular follow-ups
12. IPD Sharing Statement
Learn more about this trial
Assessment of GBR in Augmentation of Horizontally Atrophic Maxillary Ridge Using Collagen Membrane Versus Using Titanium Mesh
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