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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 techniqueâ„¢ versus using the same mixture covered with titanium mesh.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| titanium mesh | Active Comparator | using non resorbable titanium mesh to fix and cover the onlay bone graft mixture to the atrophic maxillary ridge. |
|
| collagen membrane(Sausage technique) | Experimental | using resorbable collagen membrane with the sausage technique to fix the onlay bone graft mixture to the resorbed atrophic maxillary ridge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| titanium mesh | Procedure | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 3 weeks |
| infection | suppuration collection related to the membrane and flap, its a binary outcome (yes/No) examined and recorded by the investigator. | 10 days |
| inflammation | redness and tenderness of the flap, its a binary outcome (yes/No) examined and recorded by the investigator. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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the participants are divided into two groups one control and the other is the intervention
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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
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| collagen membrane (Sausage technique) | Procedure | the resorbable collagen membrane is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge. |
|
| 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 %) | at 6 months |