Comparative Study of Algipore and Decalcified Freeze-dried Bone Allograft in Open Maxillary Sinus Augmentation

Study Overview
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Brief Summary
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The aim of this study was the radiographic and clinical comparison of Algipore with decalcified freeze-dried bone allograft (DFDBA) in the open maxillary sinus lift technique using piezoelectric instruments.

Detailed Description
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Vertical and horizontal bone resorption of the alveolar ridge are common in edentulous jaws. In the distal area of the maxilla, an adequate bone volume is often lacking because of the proximity of the sinus cavities to crestal bone. Sinus floor augmentation is an established way of increasing the height and volume of bone in the posterior region of the maxilla, which increase the stability of dental implants. For this purpose various materials, including auto grafts, allografts, alloplasts, and xenografts have been used.

Official Title
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Comparative Study of Algipore and Decalcified Freeze-dried Bone Allograft in Open Maxillary Sinus Elevation Using Piezoelectric Surgery

Conditions
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Disorder of Maxillary Sinus, Maxillary Sinus Floor Augmentation

Intervention / Treatment
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* Procedure: Open Sinus Lift


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: physically healthy patients ridge bone height of less than 5 mm Exclusion Criteria: any past medical history of systemic or localized diseases that were contraindications for sinus or implant surgery
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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open Sinus Lift with DFDBA<br>In each patient, one sinus was chosen at random and filled with DFDBA (Tissue Regeneration Corporation, Iran). | Procedure: Open Sinus Lift<br>* A crestal incision was made on the mucosa of the edentulous ridge. The flap was elevated carefully and extended labially to expose the bone. A vertical releasing incision was made in the mesial end of the flap as needed. The mucoperiosteal flap was extended to expose the alveolar ridge and the lateral wall of the maxillary sinus. Then, a window was prepared using the piezoelectric device (Mectron, Italy); the Schneiderian membrane was then elevated conservatively according to the technique described by Vercellotti (2001). The sinus membrane was meticulously detached and pushed superiorly to allow for the placement of bone graft material.<br>|
| Experimental: Open Sinus Lift with Algipore<br>The contra lateral sinus was filled with Algipore (Dentsply, USA). | Procedure: Open Sinus Lift<br>* A crestal incision was made on the mucosa of the edentulous ridge. The flap was elevated carefully and extended labially to expose the bone. A vertical releasing incision was made in the mesial end of the flap as needed. The mucoperiosteal flap was extended to expose the alveolar ridge and the lateral wall of the maxillary sinus. Then, a window was prepared using the piezoelectric device (Mectron, Italy); the Schneiderian membrane was then elevated conservatively according to the technique described by Vercellotti (2001). The sinus membrane was meticulously detached and pushed superiorly to allow for the placement of bone graft material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in bone height | Baseline and 9 months radiographs were scanned with an Agfa scanner at 1200 dpi with a 12-bit grayscale and stored in JPEG format. Changes in bone height were calculated in each case. Two reference points, one at the lowest part of the ridge crest and the other at the highest part of sinus floor, were selected in two radiographs (baseline and after 9 months) and their distance was calculated in 0.1mm scale using computer. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Density | Changes in radiographic density after sinus grafting were evaluated using densitometry. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinus Floor Augmentation, Bone Transplantation, Bone Substitute