Alveolar Ridge and Soft Tissue Augmentation Using Graft From the Maxillary Tuberosity

Study Overview
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Brief Summary
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In the study immediate implant is placed in the anterior region with autogenous bone grafting from the maxillary tuberosity in one group and in the other group immediate implant is placed with xenograft .IN both groups soft tissue grafting is done using connective tissue assessment of buccal bone thickness and soft tissue will be done 6 months post operative

Detailed Description
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immediate implant will be placed in the anterior region with autogenous graft from the maxillary tuberosity and in the other group immediate implant will be laced with xenograft soft tissue grafting using sub-epithelial connective tissue will in both groups assessment of buccal bone thickness is the primary outcome of the study, while volumetric assessment of the soft tissue and patient satisfaction are the secondary and tertiary outcome the assessment of all outcome will be 6 months post operative the extraction socket in which the implant will be placed are class I&II

Official Title
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Localized Alveolar Ridge Reconstruction and Soft Tissue Augmentation Using a Triple Graft From the Maxillary Tuberosity Simultaneous With Immediate Implant Placement ( a Randomized Clinical Clinical Study)

Conditions
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Immediate Implant Placement

Intervention / Treatment
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* Procedure: maxillary tuberosity bone graft (autogenous graft)
* Procedure: Bone graft (xenograft)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patients (American Society of Anesthesiologists I; ASA I). Age range (20-40) years. Good compliance with the plaque control instructions following initial therapy. Patients diagnosed with bone defect in the maxillary anterior esthetic zone (class 1 & 2) Availability for follow up and maintenance program. Exclusion Criteria: Peri apically infected teeth Presence of smoking habit. Presence of occlusal interferences. Pregnant females. Vulnerable group of patients (handicapped, mentally retarded and prisoners) (according to the recommendation of esthetical committee of Faculty of Dentistry Ain Shams University).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two group in which the same procedure is done ( immediate implant placement) using different bone grafts
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: immediate implant with bone graft (autogenous)<br>with immediate implant placement autogenous grafting using maxillary tuberosity will be done | Procedure: maxillary tuberosity bone graft (autogenous graft)<br>* the usage of maxillary tuberosity as source of autogenous graft supplying the needed cells for bone regeneration<br>|
| Active Comparator: immediate implant with bonegraft (xenograft)<br>with immediate implant placement grafting with xenograft will be done | Procedure: Bone graft (xenograft)<br>* xenograft is bone graft material that is obtained from porcine, bovine or equine source<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| buccal bone thickness | measuring the buccal bone thickness using CBCT | at baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volumetric assessment of soft tissue | assessment of the soft tissue thickness after soft tissue augmentation using sub- epithelial connective tissue | 6 months post opertive | 
| patient satisfaction | questionnaire in which the scale is from (0 to 10) where 0 is completely unsatisfied and 10 totally satisfied | after 6 month |