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Completed

NCT Number: NCT01735721

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

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.

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Key information

Conditions

Disorder of Maxillary Sinus Maxillary Sinus Floor Augmentation

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Amir Moeintaghavi

Mashhad, Razavi Khorasan Province, 91735-984, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Sinus Lift

Procedure

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.

Primary outcomes

  1. increase in bone height

    Time frame: 9 months

    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.

Secondary outcomes

  1. Bone Density

    Time frame: 9 months

    Changes in radiographic density after sinus grafting were evaluated using densitometry.

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 28, 2012
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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