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The goal of this clinical trial is to compare in patients with atrophied anterior maxilla, bone augmentation techniques ( gold standard bone block and tent pole technique).
The main question it aims to answer is :
Does screw tent pole technique provides better bone gain than autogenous bone block in atrophied anterior maxilla?
• Research question: Does screw tent pole technique provides better bone gain than autogenous bone block in atrophied anterior maxilla?
• Rationale for conducting the research: Several methods have been developed for the augmentation of the deficient bone volume. These include Guided Bone Regeneration (GBR) with barrier membranes, onlay bone grafting, ridge splitting and distraction osteogenesis.
The screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies. Previous studies have proven that screw tent pole technique is recommended in reconstruction of atrophied alveolar bone and its good outcome in contrary to other bone graft techniques.
This study aim to compare the outcome of screw tent pole technique to conventional gold standard technique of block bone grafts in atrophied anterior maxilla.
• Primary and secondary objectives:
primary objective to assess amount of bone gain
secondary objective assess bone quality . Trial design: Randomized clinical trial, Unicentered, Parallel groups, 2 arms, Allocation ratio 1:1, Equivalent trial • PICO: Population: patients with atrophied Anterior Maxillary area (with initial ridge width of ≤ 5 mm and moderate bone height) Intervention: Screw Tent-Pole technique Control group: Autogenous Bone Block technique Outcome: bone gain , histomorphometric evaluations, dehiscence.
Interventions
A. Screw Tent pole technique
A full-thickness flap is retracted to expose the alveolar bone (augmented site).
The screw will be removed, Histopathological biopsy sample of bone will be taken using trephine bur (the same size as pilot drill) and sequential drilling will be done for implant placement at the same visit.
B. Autogenous bone block technique
A full-thickness flap is retracted to expose the alveolar bone (augmented site).
The screw will be removed, Histopathological biopsy sample of bone will be taken using trephine bur (the same size as pilot drill) and sequential drilling will be done for implant placement at the same visit.
• Post-operative care:
Clinical follow up:
-The dehiscence will be followed up every month.
Radiographic follow up:
-Immediately after surgery and after six months, CBCT will be obtained to evaluate bone gain in each group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tent pole technique | Experimental | The screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies |
|
| autogenous bone block technique | Active Comparator | Bone block graft has been the gold standard for restoring deficient regions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tent pole technique | Procedure | The screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Gain | to assess amount of bone gain before and after 6 month of the surgical procedure | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Bone quality evaluation | the bone quality through bone core biopsy by trephine bur will be evaluated in the two techniques after 6 months post-operative | 6 month post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| soft tissue dehiscence | the soft tissue around the surgical site will be evaluated periodically through clinical inspection for 6 months post-operative | monthly for 6 months post-operative |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youmna M Abdelhady | Contact | 01066302239 | youmna.abdelhady@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Youmna M Abdelhady | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| Autogenous bone block technique | Procedure | Bone block graft has been the gold standard for restoring deficient regions. |
|
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |