One-stage Versus Two-stage Inverted U-shaped Ridge Splitting

Study Overview
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Brief Summary
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Fourteen patients having anterior maxillary undercut defect were selected to match a list of inclusion and exclusion criteria. The participants were randomly allocated using a computer system into two groups: Group A undergo inverted U-shaped maxillary ridge splitting using piezotomes with simultaneous implant placement in the same surgery. Group B undergo inverted U-shaped maxillary ridge splitting as a first stage and after four weeks, ridge expansion and implant placement will be performed with only envelop flap. Assessment included measurements of bone gain at the undercut defect and bone density labial to implants in each group from the cone-beam computed tomography

Official Title
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One-stage Versus Two-stage Inverted U-shaped Ridge Splitting With Simultaneous Implant Placement for Treatment of Anterior Maxillary Alveolar Ridge Undercut (a Comparative Randomized Clinical Trial)

Conditions
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Maxillary Ridge Augmentation

Intervention / Treatment
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* Procedure: One stage ridge splitting with simultaneous implant placement
* Procedure: Two-stage ridge splitting with implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Adult patients (20-45) years of age with no sex predilection At least one tooth missing in the anterior maxilla The presence of a labial undercut >2 mm in thickness which is not able to house an implant The presence of adequate bone width near the alveolar bone crest The absence of a vertical bone defect. Exclusion criteria History of any systemic disease that would contraindicate surgery example uncontrolled diabetes. Pregnancy or lactation. Long-term amino-bisphosphonate therapy. Smoking more than 10 cigarettes per day. Alcohol or drug abuse. Uncontrolled periodontal disease. Active infection. Inadequate inter-incisal space. Bruxism or clenching.

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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No

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One stage ridge splitting<br> | Procedure: One stage ridge splitting with simultaneous implant placement<br>* A full mucoperiosteal flap was raised using the sharp periosteal elevator to expose the bone crestally and buccally. An inverted U-shaped bone cut, down to the cancellous bone, was done in the undercut area with a piezoelectric device. The horizontal bone cut was made apical to the most concave point in the undercut area with a distance of 3 mm. The two vertical bone cuts were placed at least 1 mm away from the adjacent roots and extended beyond the undercut area. The released bone end was minimally elevated using a periosteotome through a greenstick fracture. All implants were installed with the implant shoulders flush to the bone level using a low-speed drilling procedure.<br>|
| Experimental: Two-stage ridge splitting<br> | Procedure: Two-stage ridge splitting with implant placement<br>* The first surgery is the same as one stage ridge splitting Four weeks later, after revascularization between the bone block and the mucoperiosteum, the second surgery will be performed. A crestal incision was done and the envelope flap slightly elevated to preserve the blood supply. The implants will be placed in the same manner as one stage ridge splitting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone density buccal to the implant | Bone density was evaluated by CBCT | baseline and 4 months | 
| Change in bone width gain at the undercut area | Bone width gain was evaluated by CBCT | baseline and 4 months |