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

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

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.

Study Overview

• Status: Completed
• Conditions: Disorder of Maxillary Sinus; Maxillary Sinus Floor Augmentation
• Intervention / Treatment: Procedure: Open Sinus Lift

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Khorasan Razavi
    • Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735-984
      • Amir Moeintaghavi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open Sinus Lift with DFDBA; In each patient, one sinus was chosen at random and filled with DFDBA (Tissue Regeneration Corporation, Iran).	Procedure: Open Sinus Lift; 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.
Experimental: Open Sinus Lift with Algipore; The contra lateral sinus was filled with Algipore (Dentsply, USA).	Procedure: Open Sinus Lift; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mashhad University of Medical Sciences
• Investigators: Study Director: Amir Moeintaghavi, DDS., Msc., Mashhad University Of Medical Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: November 25, 2012
• First Submitted That Met QC Criteria: November 25, 2012
• First Posted (Estimate): November 28, 2012

Study Record Updates

• Last Update Posted (Estimate): April 8, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Sinus Floor Augmentation; Bone Substitute; Bone Transplantation
• Other Study ID Numbers: 86319